Fax: 301-847-8543

Email: henry.allen@fda.hhs.gov
24 hour Emergency Number: 1-866-300-4374

lus U.S. FOOD & DRUG

ADMINISTRATION

Hoo-o

From: Allen, Henry

Sent: Monday, June 15, 2020 12:08 PM

To: SH1@fda.hhs.gov

Cc: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Russo, Mark <Mark.Russo@fda.hhs.gov>; Carter, Lionel

<Lionel.Carter@fda.hhs.gov>; 'CAPT Joshua Simms' <Joshua.Simms@fda.hhs.gov>
Subject: Please Call Dr. Peter Navarro at (b)(6)) 7)
Importance: High

Dr Hahn:

lam the FDA Late Duty Officer this week and just received a call via the White House Situation Room.
Please call Dr. Peter Navarro at (b)(6))))))) once you’re off the phone with Dr. Birks.

This call was relayed through the White House Situation Room - Melissa Pomala —(b) (6) 9)

The requestor was Joanna Miller - (6) (6). — calling on behalf of Dr. Peter Navarro - (BYE)

Very respectfully,

LCDR Henry Allen, USPHS

Emergency Operations Center (EOC) Manager
COVID-19 FDA Incident Management Group (IMG)
FDA Late Duty Officer

Office of Emergency Operations

Office of Emergency Management

U.S, Food and Drug Administration

Desk: 301-796-8444

eal
Fax: 301-847-854,

Email: henry.allen@fda.hhs.gov
24-hour Emergency Number: 1-866-300-4374

iy U.S. FOOD & DRUG

ADMINISTRATION

HoOO-


From: Shah, Anand <Anand.Shah@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 10:35 AM

To: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum @fda.hhs.gov>;
Guram, Jeet <Jeet.Guram@fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi
<Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne *
<Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle <Dayle.Cristinzio@fda.hhs.gov>

Subject: RE: Comms Touch Base: HCQ

Totally agree — we will build all this in and send a revised version shortly

From: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 10:33 AM

To: Shah, Anand <Anand.Shah@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum@fda.hhs.gov>; Guram, Jeet
<Jeet.Guram@fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>;
Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne * <Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle

<Dayle.Cristinzio@fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ

From: Shah, Anand <Anand.Shah@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 10:29 AM

To: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum@fda.hhs.gov>;
Guram, Jeet <Jeet.Guram@fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi
<Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne *
<Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle <Dayle.Cristinzio@fda.hhs.gov>

Subject: RE: Comms Touch Base: HCQ

All good feedback. Would like to emphasize that we do not regulate YG) yyy

From: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 10:26 AM

To: Felberbaum, Michael <Michael.Felberbaum @fda.hhs.gov>; Shah, Anand <Anand.Shah@fda.hhs.gov>; Guram, Jeet
<Jeet.Guram @fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>;
Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne * <Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle

<Dayle.Cristinzio@fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ

From: Felberbaum, Michael <Michael.Felberbaum@fda.hhs.gov>
Sent: Wednesday, June 17, 2020 10:21 AM
To: Shah, Anand <Anand.Shah@fda.hhs.gov>; Guram, Jeet <Jeet.Guram @fda.hhs.gov>; Lenihan, Keagan



INTERNAL FDA USE ONLY

Agenda and notes — JIC 10:00 a.m. check-in

June 17, 2020

JIC daily check-in M-F, 10:00 — 10:30 a.m. WebEx only. For first part of meeting, we will run down status
of current items, then focus on hot topics, if any. After the meeting, updated notes will be available in
SharePoint (JIC [ HYPERLINK "http://sharepoint. fda. gov/orgs/OC-
OCET/OCETdoces/nCoV/default.aspx?RootF older=%2Forgs%2FOC%2DOCET%2FOCETdocs
%2FnCoV%2FShared%20Documents%2FJIC%20%2D%20FDA%20IMG%2FMeeting%20note
s&FolderCTID=0x012000A3A7A055F609174BBA 12CCDSOBB2BD50& View=%7bAA5DS76
D-A152-4B9E-B345-979F92F9C4C9%7d" J).

Reminders/notes/resources:

Please ask, "Who else needs to know?" (remember to use JIC email lists, in case people are on
leave - "Which email do | use?" is included in the [ HYPERLINK "http://sharepoint.fda.gov/orgs/OC-
OCET/OCETdocs/nCoV/Shared%20Documents/JIC%20-
%20FDA%20IMG/20200603_WelcomeToJIC.pdf" ])

[ HYPERLINK “https://www.statnews.com/2020/06/16/major-study-finds-common-steroid-
reduces-deaths-among-patients-with-severe-covid-19/" ] (STAT, referring to dexamethasone)

TODAY’S FOCUS DISCUSSION (Second half of meeting)

Hot topics for the group
= From NICCL call - HHS will issue a press release on distribution of remdesivir Saturday
morning

Pending, from previous discussions:

ACTION: teams will review their evergreen content, including [ HYPERLINK
"http://sharepoint.fda.gov/orgs/OC-OCET/OCETdocs/nCoV/Shared%20Documents/JIC%20-
%20FDA%20IMG/Social%20media/Evergreen%20Tweet%20Repository%20Approved%204.17.20.d
ocx" ], for continued relevance/appropriateness of use, and we'll discuss w/new ideas on
Thursday June 18

Press/Media Engagements:
What is Dr. Hahn up to today
White House (TPs, when needed: Michael F.)

Then, by area:
Press releases/media/WHTF
CDRH

CDER

CBER

CFSAN

CcVM

ORA

OPLIA

CTP

occ

OL

Consumer

[PAGE \* MERGEFORMAT ]


Dr. Hahn, attached for your review this evening:

.

Meeting memo & talking points for call with the American College of Rheumatology

. ITEM #1: Call with the American College of Rheumatology
Action: Edit By 9:00am
Wednesday 07302020American College of Rheumatology Invited participants.docx

07302020ACRcall.docx

Have a great night!


From: Shah, Anand [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=E2172EBBD96946CO8E189FD612855F51-ANAND.SHAH]

Sent: 6/19/2020 3:25:09 PM

To: Lenihan, Keagan [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=ee7320ee8c184d66bfd521b0105d17d2-Keagan.Leni)

Subject: RE: Comms Touch Base: HCQ.

Will definitely do — and thanks for the feedback this afternoon

From: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>
Sent: Friday, June 19, 2020 2:29 PM

To: Shah, Anand <Anand.Shah@fda.hhs.gov>

Subject: FW: Comms Touch Base: HCQ

FYSA — lets work with CDER on the front end of things so we don’t run into this issue. Pls reach out directly to Patrizia on
initial asks and she will help figure out the best way to put the info together.

From: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>
Sent: Friday, June 19, 2020 12:22 PM

To: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ

Patrizia

From: Shreeve, Chris <Christine.Kuethe@fda.hhs.gov>

Sent: Thursday, June 18, 2020 6:44 PM

To: Beers, Donald <Donald.Beers@fda.hhs.gov>

Cc: Clarke, Mary Beth <Marybeth.Clarke@fda.hhs.gov>; Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Cavazzoni,

Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Shah, Anand <Anand.Shah@fda.hhs.gov>; Felberbaum, Michael
<Michael.Felberbaum @fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi

<Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne *

<Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle <Dayle.Cristinzio@fda.hhs.gov>; Guram, Jeet <Jeet.Guram@fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ

Don,

Here is the document with Dr. Cavazzoni edits and ORP’s. Please let me know if you need anything further for your
review.

Thanks,
Chris

From: Shreeve, Chris

Sent: Wednesday, June 17, 2020 5:08 PM

To: Beers, Donald <Donald.Beers@fda.hhs.gov>

Cc: Clarke, Mary Beth <Marybeth.Clarke@fda.hhs.gov>; Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Cavazzoni,


CONFIDENTIAL, DELIBERATIVE, INTERNAL
Draft 6/29/20

MEMORANDUM

This memorandum provides a summary of the GAO report titled “Opportunities to Improve Federal
Response and Recovery Efforts” issued to Congress on June 25, 2020, with regard to FDA’s actions to
address challenges during the COVID-19 pandemic.

Background

The CARES Act requires GAO to submit a report on its monitoring and oversight efforts related to the
COVID-19 pandemic, with subsequent bimonthly reports through March 2021. The first report focuses on
(1) the key actions the federal government has taken, (2) potential indicators for monitoring the public
health system’s preparedness, and (3) evolving lessons learned relevant to the nation's response.

The primary challenges highlighted in the report include CDC’s incomplete and inconsistent reporting of
viral testing, shortages of critical supplies, and potential for fraud in the paycheck protection program.
GAO’s recommendations are focused on SBA, IRS, DOL and DOT, and further recommendations may be
issued based on GAO’s ongoing work as described below.

FDA’s Efforts and GAO’s Ongoing Review

FDA’s actions are discussed in connection with other federal partners’ efforts and challenges with respect
to the Strategic National Stockpile (SNS), COVID-19 testing, and vaccine development.

Below is a summary of the FDA’s actions cited in the report and issues that GAO is continuing to review:

e SNS: When describing the depletion of the stockpile’s resources, GAO references the FDA’s
issuance and revocation of the EUA for hydroxychloroquine, and FDA’s EUA for remdesivir. The
GAO states that it is conducting a comprehensive body of work on the SNS which will include
examining state requests, purchasing decisions, and restructuring the SNS based on lessons learned.

e COVID-19 Testing: When describing delays and reporting gaps in COVID-19 testing, GAO
addresses FDA’s policy changes to increase testing capacity in response to concerns around
accuracy and reliability issues associated with the CDC-deployed test. In addition, GAO noted that
FDA has limited authority to address supply shortages for testing, but took steps to encourage
increased manufacturing of supplies, e.g., swabs and transport media. GAO states that it will
continue to conduct work examining HHS and its component agencies’ roles with regard to testing.

e Vaccine Development: GAO references COVID-19 appropriations for the development of medical
countermeasures and vaccines, and notes the FDA’s participation in the ACTIV partnership and
creation of CTAP. GAO clarifies the scope of EUA authority and provides a summary of active
trials and development programs for therapeutics. GAO plans to conduct further work on federal
efforts to accelerate and coordinate development and testing of vaccines and therapeutics, and the
process and policies related to their development, approval, and distribution.

e Food Safety: GAO indicates that it will explore FDA’s response on food safety during COVID-19,
and notes that the CARES Act did not appropriate supplemental funds for inspections.

Although FDA was not a significant focus of the June 25 report, it is likely that the agency will receive
additional requests for information for subsequent reports. Testing and vaccine development, supply chain
resiliency, and food safety are likely to be relevant topics where FDA will need to provide further
information.


From: Shreeve, Chris [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=571674B26CA64F5 78288F392644 70299-CHRISTINE.K]

Sent: 6/18/2020 8:51:53 PM

To: Beers, Donald [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=d079bf15a01744bd94687d67 18ca4c42-Donald.Beer])

cc: Clarke, Mary Beth [/o=ExchangeLabs/ou=Exchange Administrative Group

(FYDIBOHF23SPDLT)/cn=Recipients/cn=b0124a15b9344d8483929470fefa403a-CLARKEM]; Lenihan, Keagan
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=ee7320ee8c184d66bfd521b0105d17d2-Keagan.Leni]; Cavazzoni, Patrizia
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=c42abd33834044ecbaa03d075cc0a5d2-Patrizia.Ca]; Shah, Anand
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=e2172ebbd96946c08e189fd612855f51-Anand.Shah]; Felberbaum, Michael
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=4819a643ca2945cdb1a2631b83e69673-Michael.Fel]; Caliguiri, Laura
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=aa086f2d6c0346c49e996932d86ac62e-Laura.Calig]; Rebello, Heidi
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=2834ce193ca949799ef063e34a2cfa0b-Heidi.Rebel]; Caccomo, Stephanie
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=950c32cebc4b4f80b302c50cf31c8524-Stephanie.C]; Pines, Wayne *
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=0e9f5ce0254041a48966c10d0c38bef5-Wayne.Pines]; Cristinzio, Dayle
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=b5a8dc4e587946fa9387 14a962df4246-Dayle.Crist]; Guram, Jeet
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=ef73bea97e2b477b847ea302c4730ccf-Gurjeet.Gur]

Subject: RE: Comms Touch Base: HCQ

Thank you.

From: Beers, Donald <Donald.Beers@fda.hhs.gov>

Sent: Thursday, June 18, 2020 7:27 PM

To: Shreeve, Chris <Christine.Kuethe @fda.hhs.gov>

Cc: Clarke, Mary Beth <Marybeth.Clarke@fda.hhs.gov>; Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Cavazzoni,
Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Shah, Anand <Anand.Shah@fda.hhs.gov>; Felberbaum, Michael
<Michael.Felberbaum @fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi
<Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie <Stephanie.Caccomo @fda.hhs.gov>; Pines, Wayne *
<Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle <Dayle.Cristinzio@fda-hhs.gov>; Guram, Jeet <Jeet.Guram@fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ

Thanks, Chris. (5)(5)) If there are further changes before finalization, | guess |
should look again.

Don

From: Shreeve, Chris <Christine.Kuethe@fda.hhs.gov>

Sent: Thursday, June 18, 2020 6:44 PM

To: Beers, Donald <Donald.Beers@fda.hhs.gov>

Cc: Clarke, Mary Beth <Marybeth.Clarke@fda.hhs.gov>; Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Cavazzoni,
Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Shah, Anand <Anand.Shah@fda.hhs.gov>; Felberbaum, Michael
<Michael.Felberbaum @fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi

<Heidi.Rebello@ fda.hhs.gov>; Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne *



From:

Sent:
To:

Emery, John [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP.
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=C68B7BBB994D48FDB2F6F6802BFDB605-JOHN.EMERY]

6/25/2020 1:06:34 PM

Amin, Stacy [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=cb3764b7438648838c¢22881a06fc6afb-Stacy.Amin]; Dickinson, Elizabeth
(FDA) [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=05cb143d66ed470ebe4dba5c54a88074-EDickins]; Raza, Mark
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=5811a7d72ee34aa7 8ff3c8ccb59f92ee-MRaza]; Kempic, Annamarie
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=c9cb9e4f9d4d4e6382380a216e50a99c-AKempic]; Edmonds, Amanda
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=232186a24a53474298d2760c060a4cc7-Amanda.Edmo]; Williams, Susan
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=63c6055 73234410491 fad54cde597ecd-Susan.Willi]; Hong, Samantha
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=9bf5fc8a16d344725f02478016a3469d-Samantha.Ho]; Beers, Donald
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=d079bf15a01744bd94687d67 18ca4c42-Donald.Beer]; Sadove, Elizabeth
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=fd45c627000d4f34b9db362ff2b6af4b-SADOVEE]; Cavazzoni, Patrizia
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=c42abd33834044ecbaa03d075cc0a5d2-Patrizia.Ca]; Sipes, Grail
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=ccee8d18ee1f4a36885078f780c2f2f8-SIPESG]; Farley, John
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=d9dc8109c3ea49ed8f897ac979b0619b-FARLEYJ]; Birnkrant, Debra B
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=07e740904c9042a0b99c6ddc16550b08-BIRNKRANT]; Schumann, Katherine
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=c3e4251f58ae47b195422a2349bSe3ce-SCHUMANNK]; Walinsky, Sarah
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=97a2ad6b3c4549a78542fce1a086f7ea-Sarah.Walin]; Booze, Kristen
[/o=ExchangeLabs/ou=Exchange Administrative Group

(FYDIBOHF23SPDLT)/cn=Recipients/cn=8633826 Lbf6646c59bf&cf7c18d12de3-Kristen.Boo]; Corrigan-Curay,
Jacqueline [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=cff7c455d5d24bc69c1239a23041a596-Jacqu.Corri]; Gormley, Andrea
(Vincent) [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=a3bcfc81bde2490abfb3b4180df23918-VINCENTA]; Leissa, Brad G
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=79e04d8b4cdf4ac7a9e823c966eefSc2-LEISSAB]; Woodcock, Janet
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=7b0453354a9a427db0a66a86c7a36f3d-Janet.Woodc]; Hodowanec, Aimee
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=01a4ec98d46a47e7847a33f14b1ee4f8-Aimee.Hodow]; Singer, Mary
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=dceb8503eea54637923bdcaec04e4349-SINGERM]; Ashley, Donald
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=40241a76230349cbb195ab1721092196-Donald.Ashl]; Leboeuf, Andrew
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=d35ec585598148118abdfd25f495c8f5-Andrew.Lebo]; Hinton, Denise
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=85feca0be0694803be6030e97c7b4adb-HINTOND); Fan, Jianghong
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=54b7399df3ea4787b5763c231ae7fbd3-Jianghong.F]; Zheng, Nan
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=841ac2bd98db4e21a610031444394f74-Nan.Zheng]; Zhang, Xinyuan



Chris Shreeve
Director, Office of Communications

Center for Drug Evaluation and Research
U.S, Food and Drug Administration
Tel: 240-402-5772

chris.shreeve@fda.hhs.gov

From: Guram, Jeet <Jeet.Guram @fda.hhs.gov>

Sent: Wednesday, June 17, 2020 3:20 PM

To: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Shah,
Anand <Anand.Shah@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum @fda.hhs.gov>; Caliguiri, Laura
<Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie
<Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne * <Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle
<Dayle.Cristinzio@fda.hhs.gov>; Shreeve, Chris <Christine.Kuethe@fda.hhs.gov>

Cc: Clarke, Mary Beth <Marybeth.Clarke@fda.hhs.gov>; Beers, Donald <Donald.Beers@fda-hhs.gov>

Subject: RE: Comms Touch Base: HCQ

No problem — looping in Don Beers as well, here is a first draft for review.

Jeet Guram, M.D.
Senior Advisor, Office of the Commissioner
Food and Drug Administration

+1 (202) 230-0451 | jeet.guram@fda.hhs.gov

From: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 11:23 AM

To: Guram, Jeet <Jeet.Guram @fda.hhs.gov>; Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Shah, Anand
<Anand.Shah@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum @fda.hhs.gov>; Caliguiri, Laura
<Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie
<Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne * <Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle
<Dayle.Cristinzio@fda.hhs.gov>; Shreeve, Chris <Christine.Kuethe@fda.hhs.gov>

Cc: Clarke, Mary Beth <Marybeth.Clarke@fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ

Thank you, Jeet.

From: Guram, Jeet <Jeet.Guram@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 11:07 AM

To: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Shah, Anand <Anand.Shah@fda.hhs.gov>; Lenihan, Keagan
<Keagan.Lenihan@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum@fda.hhs.gov>; Caliguiri, Laura
<Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie
<Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne * <Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle
<Dayle.Cristinzio@fda.hhs.gov>; Shreeve, Chris <Christine.Kuethe@fda.hhs.gov>

Cc: Clarke, Mary Beth <Marybeth.Clarke@fda.hhs.gov>

Subject: RE: Comms Touch Base: HCQ



INTERNAL FDA USE ONLY

© Kaiser Permanente Mid-Atlantic States; [ HYPERLINK
"https://www.fda.gov/media/139066/download" ] (molecular; home collection kit)

© Applied BioCode Inc.; [ HYPERLINK "https://www.fda.gov/media/139046/download" ]
(molecular)

© Emory Medical Laboratories, Emory University Hospital; [ HYPERLINK
“https://www.fda.gov/media/139050/download" | (serological)

© EUA revocation: Chembio Diagnostic System, Inc.; DPP COVID-19 IgM/IgG System - [
HYPERLINK "https://www.fda.gov/media/139109/download" ]

Web updates:

© CDRH: Asymptomatic Testing Updates to testing [ HYPERLINK
"https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-testing-
sars-cov-2" ], updated molecular diagnostic EUA [ HYPERLINK
"https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
authorizations-medical-devices/vitro-diagnostics-euas" ]

o  EUA archive page updates: [ HYPERLINK “https://www.fda.gov/medical-devices/emergency-
situations-medical-devices/historical-information-about-device-emergency-use-
authorizations" ], [ HYPERLINK "https://www.fda.gov/emergency-preparedness-and-
response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization-
archived-information" \I "covid19" ]

Stakeholders:

© CDER: Drug Information Association (DIA) 2020 Virtual Global Annual Meeting: Regulatory

Agility Under COVID 19 - Jeannie David (DSS)

SITREP ENDS

MEETING REPORT OUT (see Op Tempo for dial-in #s)

[ HYPERLINK "http://sharepoint.fda.gov/orgs/OC-
OCET/OCETdocs/nCoV/default.aspx?RootFolder=%2Forgs%2FOC%2DOCET%2FOCETdocs%2FnCoV
%2FShared%20Documents%2FJIC%20%2D%20FDA%20IMG%2FOps%20meeting%20coverage&Fol
derCTID=0x012000A3A7A055F609174BBA12CCDS50BB2BD50&View=%7bAASD576D-A152-4B9E-
B345-979F92F9C4C9%7d" | updates (task forces, etc.)

Hearings/Hill briefings

NICCL calls (Tu/Th 10:15 a.m.)

MEDIA MONITORING

See daily a.m. JIC email from Andrea Takash

See [ HYPERLINK "http://sharepoint.fda.gov/orgs/OC-
OCET/OCETdocs/nCoV/default.aspx?RootFolder=%2Forgs%2FOC%2DOCET%2FOCETdocs%2FnCoV
%2FShared%20Documents%2FJIC%20%2D%20FDA%20IMG%2FNICCL%20J1IC%20%28interagency%
20comms%29&FolderCTID=0x012000A3A7A055F609174BBA12CCD50BB2BD50&View=%7bAASD5
76D-A152-4B9E-B345-979F92F9C4C9%7d" | for social listening and other reports

HHH

[PAGE \* MERGEFORMAT ]


On Jun 16, 2020, at 2:53 PM, Felberbaum, Michael <Michael.Felberbaum @fda.hhs.gov> wrote:

Here's the proposed response to the outstanding C: (5) lll
—

From: Felberbaum, Michael

Sent: Tuesday, June 16, 2020 1:13 PM

To: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Shah, Anand <Anand.Shah@fda.hhs.gov>

Ce: Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie
<Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne * <Wayne.Pines@fda.hhs.gov>; Amin, Stacy

<Stacy.Amin@fda.hhs.gov>
Subject: FLAGGING -- NYT on HCQ

INTERNAL — DELIBERATIVE — CONFIDENTIAL
Hi both,

NYT is reviving the story it was looking to do a month or so ago about CQ/HCQ EUA — how it came to be, and now the
revocation. We should expect the story in the next day or so. Stacy, just flagging given this was the reporter you spoke
with previously, there will likely be mention of the emails from the Bright complaint. The reporter has all of the previous
comment/background we’d provided, which still stands, and ASPR had provided them comment/information as well. |
don’t expect the story to be anything we haven’t already seen written on this topic and as we noted, there have been a
number of comments, etc. provided to the reporter.

The reporter has followed up with a couple of specific questions (one which was answered by our online QA) but the

rerrainireg Ca ()/(S) lc 2 For

awareness, the reporter also noted that in an interview with her, Peter Navarro called this an action of "the deep state."
ASPA is aware and | will circle back.

Michael

Michael Felberbaum
Senior Advisor

Office of Media Affairs
Office of External Affairs
U.S. Food and Drug Administration
Tel: 240-402-9548 / Cell
ael.felberbaum @fda.hi

GOV

<image002.png>

<image004.jpg>
<image006.jpg>
<image008.jpg>
<image010.jpg>

<image012,jpg>


° RADM Araojo presenting (via pre-recorded video) on Under-representation in Clinical Trials and the
Implications for Drug Development, AACR Virtual Annual Meeting II, including highlighting FDA OMHHE’s ongoing efforts
in response to COVID-19 [SP link - talking points] 6/22

. Internal:

° Updated Occupational Health employee QAs for InsideFDA in clearance

° Working on new employee QAs on workplace reopening; in development

° InsideFDA: Face Shield Alternative to Face Mask for Medical Concerns [SP link] - holding for reopening
FDA plan

Routine/daily/weekly activities:

. Daily - Prepared talking points for Commissioner Hahn for daily White House Task Force and press briefing

. Daily - Prepared/posted tweets/graphics on above topics for Commissioner and FDA accounts, and other social
media (e.g., Facebook, LinkedIn)

. Daily or as needed - updated PDFs listing EUAs for therapeutics and medical devices

. 2x/ weekly (Wed & Fri): COVID-19 response recap emails to stakeholders

. Weekly (Wed) - Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic
Tests

. Weekly (Wed): Coronavirus Q&As for Consumers — top Q&A of week email to Consumer Update list

. Ongoing internal: additional InsideFDA FAQs for employees for employees for InsideFDA, and responding to

questions received from HHS employee portal

Published yesterday, June 9
. Press statements:

Daily roundup on topics including a new ANDA, a CDER warning letter, and a testing update

°

. Dr. Hahn media:

° 7:50-8:00 a.m. Bo Thompson morning show, Charlotte, NC

° 8:05-8:15 a.m. Drew Steele show, Fort Myers, FL

. Emergency Use Authorizations:

° Euroimmun; EURORealTime SARS-CoV-2 (molecular)

° Siemens Healthcare Diagnostics Inc.; Dimension Vista SARS-CoV-2 Total antibody assay (COV2T)
(serology)

° Siemens Healthcare Diagnostics Inc.; Dimension EXL SARS-CoV-2 Total antibody assay (CV2T) (serology)
. Web updates:

° CDER WL: organic-beauty-recipes.com selling essential oils (issued 6/8)

° CDER: ANDA Approval: Succinylcholine Chloride Injection USP, 200 mg/10 mL (20 mg/mL), Multiple-Dose

Vial (ANDA 213431), which facilitates tracheal intubation and to provide skeletal muscle relaxation during surgery or
mechanical ventilation (approved 6/8, posted 6/9)

° CDER/OTS: Burst for Spotlight on CDER Science: Translating In Vitro Antiviral Activity to the In Vivo
Setting: A Crucial Step in Fighting COVID-19

° CDER: Update to Compounding Activities | COVID-19 page on product reporting from outsourcing
facilities

° ORA: update on FDA face covering policy and signage at FDA spaces: FDA Import Offices and Ports of
Entry

° COVID-19 Page FAQ updates to help public better understand FDA's role. Updated answers:

° Q: What is the FDA doing to respond to the COVID-19 pandemic?

° Q: What is an emergency use authorization and how is it being used to respond to COVID-19?
° Q: How does COVID-19 spread?

° Q: What is the FDA’s role in approving vaccines and what is being done to produce a COVID-19
vaccine?

° Q: What does it mean to be an FDA-approved drug?

° Q: What is the FDA’s role in regulating potential treatments during a public health emergency?

° Q: What is the FDA’s role in helping to ensure the safety of the human and animal food supply?


From: Anand.Shah@fda.hhs.gov [Anand.Shah@fda.hhs.gov]

Sent: 6/24/2020 5:30:13 PM

To: Cavazzoni, Patrizia [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=c42abd33834044ecbaa03d075cc0aSd2-Patrizia.Ca]

ce: Lenihan, Keagan [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=ee7320ee8c184d66bfd521b0105d17d2-Keagan.Leni]

Subject: Re: Review requested of remarks for Dr. Shah on chloroquine and Hydroxychloroquine -- BY 6 pm today

Let me check on the date - will come back to you - this was set up by OEA. It would be great to have SME from CDER.

On Jun 24, 2020, at 17:01, Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov> wrote:

When is this planned for and will you need anyone from CDER to participate?
Patrizia

From: Booze, Kristen <Kristen.Booze@fda.hhs.gov>

Sent: Wednesday, June 24, 2020 4:56 PM

To: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>

Cc: Shreeve, Chris <Christine.Kuethe@fda.hhs.gov>

Subject: FW: Review requested of remarks for Dr. Shah on chloroquine and Hydroxychloroquine -- BY 6 pm today
Importance: High

Hi Dr. Cavazzoni,
CDER was asked to review these talking points regarding the HCQ/CQ EUA revocation.
OND-Policy, OID, OMP and ORP have all edited and cleared the talking points — their edits and comments are in

SharePoint. We wanted to allow you the chance to look at their edits before stating they are CDER cleared. They’re due
at 6pm today.

http://sharepoint.fda.gov/orgs/OC-

OCET/OCETdocs/nCoV/Shared%20Documents/SH%20talking%20points/2020-06-
26%20Shah%20remarks%20for%20stakeholder%20call%200n%20HQ.1.docx

Many thanks,
Kristen

From: Wohl, Alexander <Alexander.Wohl@fda.hhs.gov>

Sent: Wednesday, June 24, 2020 10:08 AM

To: 2019-nCoV FDA IMG JIC CDER <2019-nCoVFDAIMGJICCDER@fda.hhs.gov>; 2019-nCoV FDA IMG JIC Leadership
<2019-nCoV-FDA-IMG-JIC-Leadership@fda.hhs.gov>

Cc: Fritsch, Beth F. <Beth.Fritsch@fda.hhs.gov>; Cristinzio, Dayle <Dayle.Cristinzio@fda.hhs.gov>

Subject: Review requested of remarks for Dr. Shah on chloroquine and Hydroxychloroquine -- BY 6 pm today

Good morning JIC CDER and JIC Leadership teams,


From: Finnen, April [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=43D74B830BB1D429184B0D908 1EFE19BF-APRIL.FINNE]

Sent: 6/10/2020 7:52:07 AM

To: 2019-nCoV FDA IMG JIC [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=289715a1146847558b07a33ccab6bccf-2019-nCoV F}

cc: Mair, Michael [/o=ExchangeLabs/ou=Exchange Administrative Group

(FYDIBOHF23SPDLT)/cn=Recipients/cn=f4511bdad7564d7fac7eadc7961467ab-Michael.Mai]; Hinton, Denise
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=85feca0be0694803be6030e97c7 b4adb-HINTOND]

Subject: 10:00 JIC notes

Attachments: 20200610_JICMeetingNotes.docx

JIC daily check-in M-F, 10:00 — 10:30 a.m. WebEx only. For first part of meeting, we will run down status of current
items, then focus on hot topics, if any. After the meeting, updated notes will be available in SharePoint (JIC meeting
notes folder).

Reminders/notes/resources:

. June 10, 2020: COVID-19 and Communities of Color: Implications for Health Literacy NASEM webinar, 1:00 - 2:00
p.m.

. June 10, 2020: Resilience of the Research Enterprise During the COVID-19 Crisis: Science Communication During
Crisis NASEM webinar, 2:00 - 4:00 p.m.

. CDC COVID-19 in Racial and Ethnic Minority Groups web page, including a recording of the recent webinar

COVID-19 Response: Promising Practices in Health Equity

TODAY’S FOCUS DISCUSSION (Second half of meeting)
. Hot topics for the group

Pending, from previous discussions:

. 6/9 - need for evergreen messaging (tweets?) around need for continued preventive care (Azar OpEd -
Stephanie C.)

. 6/5 - update on plans RE HCQ/CQ revocation, if any? (Anna S. looking into CDER division plans)

. 5/27 - future of FEMA How to Help web page (Brooke Courtney + web team)

Press/Media Engagements:
. What is Dr. Hahn up to today
. White House (TPs, when needed: Michael F.)

Then, by area:
Press releases/media/WHTF
CDRH

CDER

CBER
CFSAN

CVM

ORA

OPLIA

cTP

occ

OL
Consumer
Stakeholder
Web

Social

CY


From: Kadakia, Kushal [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=A10A749D49F9473AA2CD046423EE61BD-KUSHAL.KADA]
Sent: 6/29/2020 4:10:45 PM

To: Hahn, Stephen [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=a0afacOcfa3c4b98913833e38a036e9f-Stephen.Hah]
cc: Zeta, Lowell [/o=ExchangeLabs/ou=Exchange Administrative Group

(FYDIBOHF23SPDLT)/cn=Recipients/cn=9cOfc7eb68244f4cb4260898d5dacadb-Lowell.Zeta]; Shah, Anand
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=e2172ebbd96946c08e189fd612855f51-Anand.Shah]

Subject: GAO CARES Act Report -- Memo

Attachments: GAO CARES Report Memo_06.29.2020.docx

Hi Dr. Hahn,

Lowell & | drafted a memo summarizing the FDA-relevant information in the GAO’s recent report on the CARES Act
(attached). Let us know if you have any questions or need any additional information.

Best,
Kushal

Kushal Kadakia
Office of the Commissioner
+1 240 731-3885 | kushal.kadakia@fda.hhs.gov


From: Caccomo, Stephanie [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=950C32CEBC4B4F80B302CSOCF31C8524-STEPHANIE.C]

Sent: 6/15/2020 11:13:30 AM

To: Elicker, Janet [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=88e18144ad424b8398b 1fdfe85f6deSb-JElicker]; Booze, Kristen
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=86338261bf6646c59bf8cf7c18d12de3-Kristen.Boo); Baumgartner, Kristofer
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=8f49b4b6cfcf4d249f8b1802a2c7dc40-BAUMGARTNER]; Shreeve, Chris
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=571674b26ca64f578288f39264470299-Christine.K]; Hunt, Alison
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=cOf683a75ebd4235abf90d887b5f7293-Alison.Hunt]; Tantillo, Andrew
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=c43045bfeef846fa99daa0c3d4772a1c-Andrew.Tant]; Gross, Karas
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=O0b6d3dc4ee4b415d86ec634c536453b6-Kara.Gross]; McBride, Maren
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=b65d2b38307f4b489e266d2178c46793-Maren.Kahn]; Anderson, Erika
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=98606928b9a64edfb25abale3573fdfe-Eranders]; Finnen, April
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=43d74b30bb1d429184b0d9081efe19bf-April.Finne]; Cristinzio, Dayle
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=b5a8dc4e587946fa9387 14a962df4246-Dayle.Crist]; Walsh, Sandy
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=c61503c4e7884fc28b9ef6cb8f25 14ec-Sandy.Walsh]; Caliguiri, Laura
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=aa086f2d6c0346c49e996932d86ac62e-Laura.Calig]; Rebello, Heidi
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=2834ce193ca949799ef063e34a2cfa0b-Heidi.Rebel]; Lynch, Sarah
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=d24ee4a4fc6241f48110d6b35e6704ed-Sarah.Lynch]; Black, Jennifer
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=aaf8a19f3672492293a7c1b2d1498059-Jennifer.Bl]; Meister, Karen G
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=7f2cdcd99e784c6cb3e8bf49 1 fee037f-KMEISTER]; Alexander, Nicholas
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=08e1fd211c4a4c96be426218bd0711e9-Nicholas.Al]; Sykes, LaShawn
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=95f500b32a404714b 1ec349f9d002c4c-Lashawn.Syk]; Kimberly, Brad
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=08bc909ed76d49868a5ff92c3c70fb72-Bradley.Kim]; Schipper, Jodi
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=2373b9ecd1654e65992a9a5fbeeS 9630-SCHIPPERJ]; Morin, Steve
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=0e7ada1e856e450989eca92Sefcf201a-MORINS]; Cooper, Mildred
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=aa838567ff8147ffb5933a8a698133b0-Mildred.Coo]; Wohl, Alexander
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=3ee6d17fe8114d16bc6244f59d9d00b4-Alexander.W]; Mair, Michael
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=f45 11bdad7564d7fac7eadc7961467ab-Michael.Mai]; Sadove, Elizabeth
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=fd45c627000d4f34b9db362ff2b6af4b-SADOVEE]; Guevara, Bessy
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=58097ba8edea47afb3338e67 1a43dc04-Bessy.Gueva]; Klimczak, Katherine



e =CDER:

e =CBER:
°

INTERNAL FDA USE ONLY

= IIE guidances:

= Enforcement Policy for Digital Health and Stimulation Therapeutic Devices for
Physical Rehabilitation — week of 6/15

= Enforcement Policy for Ventilators and Accessories and Other Respiratory
Devices During the Coronavirus Disease 2019 (COVID-19) Public Health
Emergency (Revised) — week of 6/15

= Recalls of Medical Devices and Corrective Actions/Repairs of Electronic Products
During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency —
week of 6/15

= Enforcement Policy for Coagulation Systems for Measurement of Viscoelastic
Properties During the Coronavirus Disease 2019 (COVID-19) Public Health
Emergency — week of 6/15

= Gravity Dx’s molecular LDT to the umbrella EUA

= Becton, Dickinson and Company, Veritor SARS-CoV-2 Assay

= Spectrum Solutions LLC, SDNA-1000 Saliva Collection Device

= Rapid Rona home collection kit using Hologic's Panther Fusion COVID-19 EUA
assay

= Kaiser Permanente Mid-Atlantic home collection kit using Roche Cobas COVID-
19 EUA assay

= Additions to umbrella EUAs for various devices, ventilators, and support
accessories

Warning letter: Organic-beauty-recipes.com selling essential oils (from CDER ops sitrep - no
date)
Updated Remdesivir HealthCare Professional Fact Sheets — 6/12 or next week
Revised EUA fact sheets for remdesivir, to update info on dosing and clinical trials, and add
info on HCQ/CQ drug interaction with remdesivir ~6/12 or week of 6/15
Beyond this week:
=" Guidance: COVID-19 infection in Employees in Pharmaceutical Manufacturing (+Daily
Roundup, listserv, reactive QAs) — late June
= Guidance: Manufacturing, Supply Chain, and Drug Inspections During COVID-19 Public
Health Emergency - Questions and Answers (+Daily Roundup) — late June
= Health Affairs Blog: CDER’s Contributions Towards Protecting Public Health During the
COVID-19 Pandemic By Patrizia Cavazzoni, M.D. [[ HYPERLINK
"http://sharepoint.fda.gov/orgs/OC-
OCET/OCETdocs/nCoV/Shared%20Documents/JIC%20-
%20FDA%20IMG/CDER/HACDERWorkCovid19PandemicJune4.docx" ]] - June/July

Use of stem cells (comms and target date TBD)

e = CFSAN:

°

« = CVM:

Checklist (w/CVM): Employee Health and Food Safety Checklist for Human and Animal Food
Operations During COVID-19 [[ HYPERLINK
"http://sharepoint.fda.gov/orgs/OFVM/OFVM%20landing%20page/Cross_Cutting_Issues/Sh
ared%20Documents/FSMA%202019-2020/FSMA%20and%20COVID-
19/Employee%20Health%20Food%20Safety%20-Checklist-for-reopening-and-operation-
changes%20515TS.docx" J]

[PAGE \* MERGEFORMAT ]


Cc: Clarke, Mary Beth <Marybeth.Clarke@fda.hhs.gov>; Beers, Donald <Donald.Beers@fda.hhs.gov>; Lenihan, Keagan
<Keagan.Lenihan@fda.hhs.gov>; Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Shah, Anand
<Anand.Shah@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum @fda.hhs.gov>; Caliguiri, Laura
<Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie
<Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne * <Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle

<Dayle.Cristinzio@fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ

Hi,
Just checking. Has this gone through CDER or will it go there after Don clears? Thanks!

Chris

Chris Shreeve
Director, Office of Communications

Center for Drug Evaluation and Research
U.S, Food and Drug Administration
Tel: 240-402-5772

chris.shreeve@fda.hhs.gov

From: Guram, Jeet <Jeet.Guram @fda.hhs.gov>

Sent: Wednesday, June 17, 2020 3:20 PM

To: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Shah,
Anand <Anand.Shah@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum @fda.hhs.gov>; Caliguiri, Laura
<Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie
<Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne * <Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle
<Dayle.Cristinzio@fda.hhs.gov>; Shreeve, Chris <Christine.Kuethe@fda.hhs.gov>

Cc: Clarke, Mary Beth <Marybeth.Clarke@fda.hhs.gov>; Beers, Donald <Donald.Beers@fda.hhs.gov>

Subject: RE: Comms Touch Base: HCQ

No problem — looping in Don Beers as well, here is a first draft for review.

Jeet Guram, M.D.
Senior Advisor, Office of the Commissioner
Food and Drug Administration

+1 (202) 230-0451 | jeet.guram@fda.hhs.gov

From: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 11:23 AM

To: Guram, Jeet <Jeet.Guram @fda.hhs.gov>; Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Shah, Anand
<Anand.Shah@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum @fda.hhs.gov>; Caliguiri, Laura
<Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie
<Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne * <Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle
<Dayle.Cristinzio@fda.hhs.gov>; Shreeve, Chris <Christine.Kuethe @fda.hhs.gov>

Cc: Clarke, Mary Beth <Marybeth.Clarke@fda.hhs.gov>

Subject: RE: Comms Touch Base: HCQ

Thank you, Jeet.


Sent: Friday, June 12, 2020 11:51 AM

To: Leboeuf, Andrew <Andrew.Leboeuf@fda.hhs.gov>
Ce: Mair, Michael <Michael.Mair@fda.hhs.gov>; Sadove, Elizabeth <Elizabeth.Sadove@fda.hhs.gov>; Walinsky, Sarah
<Sarah.Walinsky@fda.hhs.gov>; Schumann, Katherine <Katherine.Schumann@fda.hhs.gov>

Subject: FW: FOUO INFORMATION NOT RELEASABLE UNDER FOIA

FYI
<< File: BARDA EUA 039 Withdrawal Letter FINAL.docx >>

From: Beers, Donald
Sent: Friday, June 12, 2020 11:44 AM
To: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Farley, John <John.Farley@fda.hhs.gov>; Sipes, Grail

<Grail.Sipes@ fda. hhs.gov>
Subject: RE: FOUO INFORMATION NOT RELEASABLE UNDER FOIA

From: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>
Sent: Friday, June 12, 2020 11:36 AM
To: Beers, Donald <Donald.Beers@fda.hhs.gov>; Farley, John <John.Farley@fda.hhs.gov>; Sipes, Grail

<Grail.Sipes@fda.hhs.gov>
Subject: FW: FOUO INFORMATION NOT RELEASABLE UNDER FOIA

(6) just called me. They need our comments asap, so that they can finalize the memo and send back to us, to be
forwarded to Commissioner Hahn.
Patrizia

From:

Sent: Friday, June 12, 2020 11:33 AM

To: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Farley, John <John.Farley@fda.hhs.gov>; Beers, Donald
<Donald.Beers@fda.hhs.gov>

Cc: (5)(G)/llll lll

Subject: FOUO INFORMATION NOT RELEASABLE UNDER FOIA

Patrizia, John and Don,

Please see our revised final draft. Comments or suggested edits are welcome.

©)
<< File: BARDA EUA 039 Withdrawal Letter FINAL.docx >>

6
Deputy Assistant Secretary
Director, Medical Countermeasure Programs


Sent from my iPad

On Aug 7, 2020, at 2:01 PM, CDER DRUG INFO <DRUGINFO @fda.hhs.gov> wrote:

Dear (®)(6)

Thank you for writing Dr. Stephen M. Hahn, Commissioner of the Food and Drug Administration (FDA). Your
email was forwarded to the Division of Drug Information, in the FDA's Center for Drug Evaluation and
Research (CDER) for a response. Due to the number of COVID-19 related inquires we have received, we
apologize for the delay in responding.

The decision to revoke the Emergency Use Authorization (EUA) for chloroquine and hydroxychloroquine was based on
clinical trial results and data, which are found in the Memorandum Explaining Basis for Revocation of EUA. This
document describes the studies that were reviewed and how FDA utilized the data in decision making.

We hope you found this information helpful.
Best regards,

Joy

Pharmacist

Division of Drug Information

Center for Drug Evaluation and Research
Tel: 855-543-DRUG (855-543-3784)
druginfo@fda.hhs.gov

Follow us
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This communication is consistent with 21 CFR 10.85(k) and constitutes an informal communication that represents our best judgment at
this time but does not constitute an advisory opinion, does not necessarily represent the formal position of the FDA, and does not bind
or otherwise obligate or commit the agency to the views expressed.



INTERNAL FDA USE ONLY

SITREP

Published today, June 9
Press statements:

© Daily roundup on topics including ... [ HYPERLINK "http://sharepoint.fda.gov/orgs/OC-
OCET/OCETdocs/nCoV/Shared%20Documents/JIC%20-
%20FDA%20IMG/Press/For%20clearance/2020.06.09.docx" J]
° oe
Dr. Hahn media:
© 7:50-8:00 a.m. Bo Thompson morning show, Charlotte, NC
© 8:05-8:15 a.m. Drew Steele show, Fort Myers, FL
Emergency Use Authorizations:
°

Web updates:
Oo.
Stakeholders:
© CDRH: [ HYPERLINK "https://www.fda.gov/medical-devices/workshops-conferences-
medical-devices/webinar-series-respirators-health-care-personnel-use-during-covid-19-
pandemic-06092020-06092020" ] - first event in series [[ HYPERLINK
"http://sharepoint.fda.gov/orgs/OC-OCET/OCETdocs/nCoV/Shared%20Documents/JIC%20-
%20FDA%20IMG/CDRH/20200609-Respirator_Webinar2.0.pptx" ] - SP link]
© CDER: [ HYPERLINK "https://www.fda.gov/about-fda/fda-pharmacy-student-experiential-
program/fda-drug-topics-cure-id-capturing-clinicians-experiences-repurposing-drugs-
inform-future-studies-era" ] for HCPs - Capturing Clinician’s Experiences Repurposing Drugs
to Inform Future Studies in the Era of COVID-1 — Speaker Heather Stone (OMP) +
outreach/SM/ webpage — 6/9
© CFSAN: Support CDC guidance on farm workers and employers + stakeholder call ~6/9
Consumers & patients:
© FDA Voices: Rare Disease Therapy Development and Access Remain Top FDA Priorities
During the Era of COVID-19 [[ HYPERLINK "http://sharepoint.fda.gov/orgs/OC-
OCET/OCETdocs/nCoV/Shared%20Documents/JIC%20-
%20FDA%20IMG/Consumer/20200604%20FDA%20Voices%20ALS%20Rare%20disease%20]I
C.docx" ]] - likely 6/9 or 6/10
Internal
© InsideFDA: Face Shield Alternative to Face Mask for Medical Concerns [[ HYPERLINK
"http://sharepoint.fda.gov/orgs/OC-OCET/OCETdocs/nCoV/Shared%20Documents/JIC%20-
%20FDA%20IMG/Internal%20comms/20200529%20-
%20Employee%20QA_Face%20Shield%20Alternative%20to%20Face%20Masks%20for%20M
edical%20Concern.docx" ]]

Likely today, June 9 [all internal confidential]
Press statements:
© Daily roundup on topics including ... [ HYPERLINK "http://sharepoint.fda.gov/orgs/OC-
OCET/OCETdocs/nCoV/Shared%20Documents/JIC%20-
%20FDA%20IMG/Press/For%20clearance/2020.06.09.docx" ]]

[PAGE \* MERGEFORMAT ]


Thanks,
Chris

From: Shreeve, Chris

Sent: Wednesday, June 17, 2020 5:08 PM

To: Beers, Donald <Donald.Beers@fda.hhs.gov>

Cc: Clarke, Mary Beth <Marybeth.Clarke@fda.hhs.gov>; Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Cavazzoni,
Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Shah, Anand <Anand.Shah@fda.hhs.gov>; Felberbaum, Michael
<Michael.Felberbaum @fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi
<Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne *

<Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle <Dayle.Cristinzio@fda.hhs.gov>; Guram, Jeet <Jeet.Guram@fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ.

Thank you, Don. We will get it through CDER as quickly as possible and then back to you.

Chris

From: Beers, Donald <Donald.Beers@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 4:42 PM

To: Shreeve, Chris <Christine.Kuethe @fda.hhs.gov>; Guram, Jeet <Jeet.Guram@fda.hhs.gov>

Cc: Clarke, Mary Beth <Marybeth.Clarke@fda.hhs.gov>; Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Cavazzoni,
Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Shah, Anand <Anand.Shah@fda.hhs.gov>; Felberbaum, Michael
<Michael.Felberbaum@fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi
<Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne *
<Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle <Dayle.Cristinzio@fda.hhs.gov>

Subject: RE: Comms Touch Base: HCQ.

Chris,

lam glad to give my feedback now, but it would probably be good for me to look again if there are further revisions. |
have a couple of comments with potential edits on the last page of the attached.

Don

From: Shreeve, Chris <Christine.Kuethe@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 3:22 PM

To: Guram, Jeet <Jeet.Guram @fda.hhs.gov>

Ce: Clarke, Mary Beth <Marybeth.Clarke@fda.hhs.gov>; Beers, Donald <Donald.Beers@fda.hhs.gov>; Lenihan, Keagan
<Keagan.Lenihan@fda.hhs.gov>; Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Shah, Anand
<Anand.Shah@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum @fda.hhs.gov>; Caliguiri, Laura
<Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie
<Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne * <Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle

<Dayle.Cristinzio@fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ

Hi,
Just checking. Has this gone through CDER or will it go there after Don clears? Thanks!

Chris


Cc: Clarke, Mary Beth <Marybeth.Clarke@fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ

Sounds good — I'll take a stab at adding info on what the original EUA meant, the data that was used to make the
decision to revoke the EUA, and what the revocation did and didn’t mean, and then I’Il send the document back around
to this group plus Don Beers.

Jeet Guram, M.D.
Senior Advisor, Office of the Commissioner
Food and Drug Administration

+1 (202) 230-0451 | ject.guram@fda.hhs.gov

From: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 10:57 AM

To: Guram, Jeet <Jeet.Guram@fda.hhs.gov>; Shah, Anand <Anand.Shah@fda.hhs.gov>; Lenihan, Keagan
<Keagan.Lenihan@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum@fda.hhs.gov>; Caliguiri, Laura
<Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie
<Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne * <Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle
<Dayle.Cristinzio@fda.hhs.gov>; Shreeve, Chris <Christine. Kuethe@fda.hhs.gov>

Cc: Clarke, Mary Beth <Marybeth.Clarke@fda.hhs.gov>

Subject: RE: Comms Touch Base: HCQ

Adding Chris Shreeve, who can make sure this goes through CDER clearance, DAV in particular since they wrote the
memo. | recommend that Don Beers also review.
Patrizia

From: Guram, Jeet <Jeet.Guram@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 10:53 AM

To: Shah, Anand <Anand.Shah@fda.hhs.gov>; Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Felberbaum, Michael
<Michael.Felberbaum @fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi

<Heidi.Rebello@ fda.hhs.gov>; Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne *
<Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle <Dayle.Cristinzio@fda.hhs.gov>

Cc: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Clarke, Mary Beth <Marybeth.Clarke@fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ.

Attaching the document as well

Jeet Guram, M.D.
Senior Advisor, Office of the Commissioner
Food and Drug Administration

+1 (202) 230-0451 | jeet.guram@fda.hhs.gov

From: Shah, Anand <Anand.Shah@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 10:52 AM

To: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum @fda.hhs.gov>;
Guram, Jeet <Jeet.Guram@fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi
<Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne *
<Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle <Dayle.Cristinzio@fda.hhs.gov>

Cc: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Clarke, Mary Beth <Marybeth.Clarke@fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ



From: Rom, Colin [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=F59636221F4340D697DBD43EE27255FB-COLIN.ROM]
Sent: 7/29/2020 7:57:03 AM

To: Hahn, Stephen [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=a0afacOcfa3c4b98913833e38a036e9f-Stephen.Hah]
ce: Lenihan, Keagan [/o=ExchangeLabs/ou=Exchange Administrative Group

(FYDIBOHF23SPDLT)/cn=Recipients/cn=ee7320ee8c184d66bfd521b0105d17d2-Keagan.Leni]; Anderson, Erika
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=98606928b9a64edfb25aba1e3573fdfe-Eranders]; Shah, Anand
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=e2172ebbd96946c08e189fd612855f51-Anand.Shah]; Rebello, Heidi
{/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=2834ce193ca949799ef063e34a2cfa0b-Heidi.Rebel]; Tobias, Lindsay
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=a4766773c717470bbc55d204b5f067b2-Lindsay.Sto]; McWilliams, Carly
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=b68c7458214244d08424fd441fea4fda-Carlyle.McW]

Subject: RE: 7/28- TUESDAY HOMEWORK - INTERNAL CONFIDENTIAL

Thank you. Will send this back to the team

From: Hahn, Stephen <SH1@fda.hhs.gov>

Sent: Wednesday, July 29, 2020 7:53 AM

To: Rom, Colin <Colin.Rom@fda.hhs.gov>

Cc: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Anderson, Erika <Erika.Anderson@fda.hhs.gov>; Shah, Anand
<Anand.Shah@fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>; Tobias, Lindsay
<Lindsay.Tobias@fda.hhs.gov>; McWilliams, Carly <Carly.McWilliams@fda.hhs.gov>

Subject: Re: 7/28- TUESDAY HOMEWORK - INTERNAL CONFIDENTIAL

Here are my comments on the talkers

1. I'd like us to communicate about the HCQ EUA revocation in a way that better reflects what happened and provide
granularity. The EUA was issued at the request of BARDA in order to get donated drug into the system. It was not
initiated by FDA and this is an important point that is often overlooked by our stakeholders. Likewise the revocation was
requested by BARDA after they reviewed the data. They then requested revocation. That was not a unilateral FDA
action.

2. [think the numbers of INDS has increased to over 200 so perhaps we can revise those numbers if accurate.

3. I'd recommend revising the following sentence: The regulatory and scientific process surrounding
such a revocation confirms the strength of the decision-making on an EUA.... To “the
regulatory and scientific process surrounding our review and assessment of EUAs during the

pandemic, confirms the strength...
Thanks
Steve

From: Colin Rom <Colin.Rom@fda.hhs.gov>

Date: Tuesday, July 28, 2020 at 10:54 PM

To: Stephen Hahn <SH1@fda.hhs.gov>

Cc: Keagan Lenihan <Keagan.Lenihan@fda.hhs.gov>, Erika Anderson <Erika.Anderson@fda.hhs.gov>, Anand
Shah <Anand.Shah@fda.hhs.gov>, Heidi Rebello <Heidi.Rebello@fda.hhs.gov>, "Tobias, Lindsay"
<Lindsay.Tobias@fda.hhs.gov>, Carly McWilliams <Carly.McWilliams@fda.hhs.gov>

Subject: 7/28- TUESDAY HOMEWORK - INTERNAL CONFIDENTIAL



From: Finnen, April [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=43D74B830BB1D429184B0D908 1EFE19BF-APRIL.FINNE]

Sent: 6/15/2020 7:41:25 AM

To: Caccomo, Stephanie [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=950c32cebc4b4f80b302c50cf3 1¢8524-Stephanie.C]; Booze, Kristen
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=8633826 1bf6646c59bf8cf7c18d12de3-Kristen.Boo]; Baumgartner, Kristofer
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=8f49b4b6cfcf4d249f8b1802a2c7dc40-BAUMGARTNER]; Shreeve, Chris
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=571674b26ca64f578288f39264470299-Christine.K]; Hunt, Alison
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=cOf683a75ebd4235abf90d887b5f7293-Alison.Hunt]; Tantillo, Andrew
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=c43045bfeef846fa99daa0c3d4772a1c-Andrew.Tant]; Gross, Karas
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=O0b6d3dc4ee4b415d86ec634c536453b6-Kara.Gross]; McBride, Maren
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=b65d2b38307f4b489e266d2178c46793-Maren.Kahn]; Anderson, Erika
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=98606928b9a64edfb25abale3573fdfe-Eranders]; Cristinzio, Dayle
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=b5a8dc4e587946fa938714a962df4246-Dayle.Crist]; Walsh, Sandy
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=c61503c4e7884fc28b9ef6cb8f25 14ec-Sandy.Walsh]; Caliguiri, Laura
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=aa086f2d6c0346c49e996932d86ac62e-Laura.Calig]; Rebello, Heidi
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=2834ce193ca949799ef063e34a2cfa0b-Heidi.Rebel]; Lynch, Sarah
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=d24ee4a4fc6241f48110d6b35e6704ed-Sarah.Lynch]; Black, Jennifer
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=aaf8a19f3672492293a7c1b2d1498059-Jennifer.Bl]; Meister, Karen G
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=7f2cdcd99e784c6cb3e8bf491fee037f-KMEISTER]; Alexander, Nicholas
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=08e1fd211c4a4c96be426218bd0711e9-Nicholas.Al]; Sykes, LaShawn
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=95f500b32a404714b 1ec349f9d002c4c-Lashawn.Syk]; Kimberly, Brad
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=08bc909ed76d49868a5ff92c3c70fb72-Bradley.Kim]; Schipper, Jodi
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=2373b9ecd1654e65992a9a5fbeeS59630-SCHIPPERJ]; Morin, Steve
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=0e7ada1e856e450989eca9 25efcf201a-MORINS]; Cooper, Mildred
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=aa838567ff8147ffb5933a8a698133b0-Mildred.Coo]; Wohl, Alexander
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=3ee6d17fe8114d16bc6244f59d9d00b4-Alexander.W]; Mair, Michael
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=f45 11bdad7564d7fac7eadc7961467ab-Michael.Mai]; Sadove, Elizabeth
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=fd45c627000d4f34b9db362ff2b6af4b-SADOVEE]; Guevara, Bessy
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=58097ba8edea47afb3338e67 1a43dc04-Bessy.Gueva]; Klimczak, Katherine
[(/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=01a6c20534774be590c50f0d455c8 1de-Katherine.K]; Van Pool, Kendall



in many cases by starting patients right when they enter the hospital and preventing the need for a ventilator). There
was an interview with a women Doctor in Texas who was prescribing HC along with the other drugs and was amazed at
the results. She was treating patients in her outpatient practice and said there where people coming to her from all
over, that were in various stages of Covid, and even she could not believe how well the treatment was working. Then
one day, she got a call from a CVS Pharmacy and they were not going to fill that patient’s prescription. She got them to
fill this one, but they said they would no longer do so in the future. The Doctor said she had to scramble to get HC for
her patients and was not sure what she was going to do.

| could go on and on. There are many interviews | have watched in the news and many other such stories found on the
internet (some videos, some articles), where Doctors have treated patients, in early stages as well as critical stages, with
great success,

Many Doctors have expressed their befuddlement with the message you are sending. Some have even stated because of
the the results of your actions that many people will die and have died. Some have even said they feel the FDA is
corrupt. Some say the FDA and others are in the pockets of the pharmaceutical companies. | certainly hope that is not
the case but | myself have certainly wondered what is really going on here.

Then there was the so called “study” of patients in the VA, that turned out to be bogus. They were patient record
reviews, never with the patients, done by, as | understand, two Ophthalmologists, and | think one was stated as having a
political bias. There were many Doctors absolutely disgusted by it. Why weren’t you and why did you not say so.

Then we have the latest one that was a big blow to HC. Are you even aware of who put it out? It was RETRACTED,
because of the peer reviews of Doctors and others who actually read it, but the damage was already done. | think this
study was probably the one that led to you stating that HC was no longer considered an effective treatment of Covid.
This has caused Governor’s to ban the off label use in their states, Pharmacies not allowed to fill prescriptions for Covid
treatment, limited it’s use to hospitals only, Doctors wondering if they will loose their license if they continue to
prescribe it for Covid. Even other countries where Doctor’s have had success with HC, have banned the use of the drug
for treatment of Covid. The problem is, | have never heard you or any others make a public correction or issue an
apology about these bogus studies. | certainly have to wonder why. Why not issue a public statement to clear the air and
once again allow it’s use if the Doctor feels it is best for their patient. As It stands now, there is complete confusion on
the matter. | am sure there are many people who still think it is way too dangerous. That it will kill you, as some have
stated. Unbelievable!

When it comes to the concerns | have heard you and others express about the heart rhythm side affect of HC. |am not a
doctor, but | have heard several Doctors dispute that. Doctors who prescribe HC for arthritis, lupus, and maybe other off
label uses. They have said that in their situations, they have only seen limited side affects with using the drug. Some
stated they used to do the heart testing with patients, but no longer feel it is necessary because it is practically non-
existent in heart healthy patients. | have heard some using HC for Covid who are testing the heart because of the
concerns even though this drug has been used for decades, with a well known track record.

Dr. Hahn, | do thank you for your service to our country. | am sorry for being rather harsh in my statements. | just feel so
passionate about this. | do personally feel that lives have been and will be lost needlessly because of the negative
connotation that has been placed on HC. Not only by the FDA and other officials, our news media, but even by many in
the medical community. | am convinced that a lot has to do with political bias. To put that bias ahead of saving lives is
beyond anything | can imagine. | heard one Doctor state that some in the medical community have broken their oath as
a Doctor, to put the health and wellbeing of their patients first. That it is a derelict of duty.

| pray that someone would step forward and set the record straight, so more lives can be saved with allowing the use of
HC and these other drugs.

Thank you and “God Bless”,
1) (a concerned citizen from (b)(6)


[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=db264f9a066044fc82aca6b12698467e-Kendall.Van]; Leggin, Brooke
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=c876a439c57d4d0abaa3c8898c803db3-Brooke.Legg]; ODonnell, Allison
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=d0cdfec112cf4f558f9650bc5591a898-Allison.ODo]; Pines, Wayne *
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=0e9f5ce0254041a48966c10d0c38befS-Wayne.Pines]; Elicker, Janet
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=88e18144ad424b8398b 1fdfe85f6deSb-JElicker]; Roberts, Michelle
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=e1c09da5d79049fb902729d7e8328a34-Michelle.Ro]; Luebke, Yasemin
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=10d526e5c46f47ce83978507a5365deS-Yasemin.Lue]; Hodnette, Jonathan
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=eea0ff4c9fe6418ea8bf16a891db85b9-Jonathan.Ho]; Campbell, Christopher
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=8e72b376d4a54dd08fcOf7ae915401d4-Christopher]; Leboeuf, Andrew
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=d35ec585598148118abdfd25f495c8f5-Andrew.Lebo]; Schumann, Katherine
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=c3e4251f58ae47b195422a2349b5e3ce-SCHUMANNK]; Walinsky, Sarah
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=97a2ad6b3c4549a78542fce1a086f7ea-Sarah.Walin]; Kraus, Stefanie
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=9d3959f3365b4fc39a7eb3245392 15bc-Stefanie.Kr]; Beers, Donald
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=d079bf15a01744bd94687d67 18ca4c42-Donald.Beer]; Raza, Mark
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=5811a7d72ee34aa78ff3c8ccb59f92ee-MRaza]; Lenihan, Keagan
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=ee7320ee8c184d66bfd521b0105d17d2-Keagan.Leni]; Abram, Anna
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=fb77660891384232a7cd9086fcbb1a3b-Anna.Abram]; Shah, Anand
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=e2172ebbd96946c08e189fd612855f51-Anand.Shah]

cc: Sipes, Grail [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=ccee8d18ee1f4a36885078f780c2f2f8-SIPESG]; Farley, John
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=d9dc8109c3ea49ed8f897ac979b0619b-FARLEYJ]

Subject: RE: Rollout Email for HCQ

Jan Elicker created a placeholder for the revocation letter link:
https://www.fda.gov/media/138945/download

Will replace w/actual letter PDF as soon as available.

Other OCET pages that will be updated today, on greenlight:

. EUA page — current EUAs
° EUA archive page — terminated EUAs (new COVID section)

From: Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>
Sent: Monday, June 15, 2020 7:36 AM
To: Booze, Kristen <Kristen.Booze@fda.hhs.gov>; Baumgartner, Kristofer <Kristofer.Baumgartner @fda.hhs.gov>;


INTERNAL FDA USE ONLY

changes%20515TS.docx" ]] mid-to-late June. Needs to go through HHS, OMB clearance after
CDC posts testing guidance (which is also in clearance)

Working to clear a reactive statement RE: the salmon and cutting boards story out of China
6/16

« = CVM:

°
e = ORA:

© Guidance: Disinfection of Surfaces on Interstate Conveyances (in OMB clearance)
© OPLIA:

°

© CTP:
°

Potentially a new blog by Europe office, emphasizing EU collaboration - week of 6/22 or
later

Feature on ORA employee's experience being in India during pandemic and visiting
hydroxychloroquine plant - possible FDA Voices - TBD on external comms

« Consumer & patient updates:

°
°

Language translation of FAQs on face coverings and for DIY ventilator makers
Getting Smarter About Food Safety: The Pandemic and Lessons Learned (based on similar
FDA Voices) ~week of 6/15

« Web updates:

°

°

OC/CDRH: User-friendly tool on website for labs that need information on test component
substitutes when supply issues arise (+ webinar)

OCET: New page: Updates on activities performed under the rapid response to COVID-19 3D
printing [ HYPERLINK "https://www.fda.gov/emergency-preparedness-and-
response/coronavirus-disease-2019-covid-19/fda-efforts-connect-manufacturers-and-
health-care-entities-fda-department-veterans-affairs-national" ] (w/NIH, VA) [[ HYPERLINK
"“http://sharepoint.fda.gov/orgs/OC-OCET/OCETdocs/nCoV/Shared%20Documents/JIC%20-
%20FDA%20IMG/CDRH/20200522_3DprintWMOU_update.docx" ] - markup; [ HYPERLINK
"http://sharepoint.fda.gov/orgs/OC-OCET/OCETdocs/nCoV/Shared%20Documents/JIC%20-
%20FDA%20IMG/Web/For%20clearance/20200612_3DprintMOU_update_OCCreview.docx"
J] maybe ~6/18 or 6/19

At-a-Glance PDF update 6/19

* Stakeholders:

°

°

CDER: Virtual/remote human factor validation testing follow-up (internal reactive Q&A)
RADM Araojo presenting (via pre-recorded video) on Under-representation in Clinical Trials
and the Implications for Drug Development, [ HYPERLINK
“https://www.aacr.org/meeting/aacr-annual-meeting-2020/aacr-virtual-annual-meeting-ii/"
], including highlighting FDA OMHHE’s ongoing efforts in response to COVID-19 [[ HYPERLINK
"http://sharepoint.fda.gov/orgs/OC-OCET/OCETdocs/nCoV/Shared%20Documents/JIC%20-
%20FDA%20IMG/Stakeholders/For%20clearance/20200622_AACRPanel%20.docx" ] - talking
points] 6/22

© Internal:

°
°
°

Updated Occupational Health employee QAs for InsideFDA in clearance (w/OO)

Working on new employee QAs on workplace reopening; in development

Updates to Occupational Health InsideFDA [ HYPERLINK
"http://inside.fda.gov:9003/EmployeeResources/EnvironmentSafetyandHealth/EmployeeSa
fetyOccupationalHealth/ucm017203.htm" J, including updated clinic visit questionnaire [[
HYPERLINK "http://sharepoint.fda.gov/orgs/OC-

[PAGE \* MERGEFORMAT ]


From: Shah, Anand <Anand.Shah@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 10:52 AM

To: Lenihan, Keagan <Keagan.lenihan@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum @fda.hhs.gov>;
Guram, Jeet <Jeet.Guram@fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi
<Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne *
<Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle <Dayle.Cristinzio@fda.hhs.gov>

Cc: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Clarke, Mary Beth <Marybeth.Clarke@fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ.

+Patrizia and Mary Beth for awareness. Jeet will be reaching out to CDER shortly to help pull it all together
Anand

From: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 10:39 AM

To: Shah, Anand <Anand.Shah@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum@fda.hhs.gov>; Guram, Jeet
<Jeet.Guram @fda.hhs.govo; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>;
Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne * <Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle

<Dayle.Cristinzio@fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ

Thanks!

From: Shah, Anand <Anand.Shah@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 10:35 AM

To: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum @fda.hhs.gov>;
Guram, Jeet <Jeet.Guram@fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi
<Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne *
<Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle <Dayle.Cristinzio@fda.hhs.gov>

Subject: RE: Comms Touch Base: HCQ

Totally agree — we will build all this in and send a revised version shortly

From: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 10:33 AM

To: Shah, Anand <Anand.Shah@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum@fda.hhs.gov>; Guram, Jeet
<Jeet.Guram @fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>;
Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne * <Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle

<Dayle.Cristinzio@fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ.

From: Shah, Anand <Anand.Shah@fda.hhs.gov>
Sent: Wednesday, June 17, 2020 10:29 AM

To: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum @fda.hhs.gov>;



From: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 10:26 AM

To: Felberbaum, Michael <Michael.Felberbaum @fda.hhs.gov>; Shah, Anand <Anand.Shah@fda.hhs.gov>; Guram, Jeet
<Jeet.Guram @fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>;
Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne * <Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle

<Dayle.Cristinzio@fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ.

From: Felberbaum, Michael <Michael.Felberbaum@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 10:21 AM

To: Shah, Anand <Anand.Shah@fda.hhs.gov>; Guram, Jeet <Jeet.Guram @fda.hhs.gov>; Lenihan, Keagan
<Keagan.Lenihan@fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi
<Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne *

<Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle <Dayle.Cristinzio@fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ

CCC) 2)
|
C—O)
Se -
LLL 1 took a quick stab at

rearranging a bit.

From: Shah, Anand <Anand.Shah@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 10:03 AM

To: Guram, Jeet <Jeet.Guram @fda.hhs.gov>; Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Caliguiri, Laura
<Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie
<Stephanie.Caccomo@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum@fda.hhs.gov>; Pines, Wayne *

<Wayne.Pines@fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ

Great, thanks for the clarification. let’s get feedback from this group and then we can circulate wider

From: Guram, Jeet <Jeet.Guram@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 10:02 AM

To: Shah, Anand <Anand.Shah@fda.hhs.gov>; Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Caliguiri, Laura
<Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie
<Stephanie.Caccomo@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum@fda.hhs.gov>; Pines, Wayne *

<Wayne.Pines@fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ

Thanks — just to clarify this has not been reviewed by CDER yet

Jeet Guram, M.D.
Senior Advisor, Office of the Commissioner
Food and Drug Administration


<Grail.Sipes@fda.hhs.gov>
Subject: RE: FOUO INFORMATION NOT RELEASABLE UNDER FOIA

From: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>
Sent: Friday, June 12, 2020 11:36 AM
To: Beers, Donald <Donald.Beers@fda.hhs.gov>; Farley, John <John.farley@fda.hhs.gov>; Sipes, Grail

<Grail.Sipes@ fda.hhs.gov>
Subject: FW: FOUO INFORMATION NOT RELEASABLE UNDER FOIA

(®))ust called me. They need our comments asap, so that they can finalize the memo and send back to us, to be
forwarded to Commissioner Hahn.
Patrizia

From:

Sent: Friday, June 12, 2020 11:33 AM

To: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Farley, John <John.Farley@fda.hhs.gov>; Beers, Donald
<Donald.Beers@fda.hhs.gov>

Ce: (6) (6) ll

Subject: FOUO INFORMATION NOT RELEASABLE UNDER FOIA

Patrizia, John and Don,

Please see our revised final draft. Comments or suggested edits are welcome.

6)
<< File: BARDA EUA 039 Withdrawal Letter FINAL.docx >>

Deputy Assistant Secretary

Director, Medical Countermeasure Programs
Biomedical Advanced Research and Development Authority
BARDA

Assistant Secretary for Preparedness and Response ASPR
Department of Health and Human Services

330 Independence Avenue, S.W. Room 640 G
Washington, D.C. 20201

Office: 202-260-0899

Mobile:
et comm
emai: (6)(6) nnn

Legally Privileged - This e-mail transmission and any documents attached to it may contain information that is legally
privileged. If you are not the intended recipient, or a person responsible for delivering this transmission to the intended
recipient, you are hereby notified that any disclosure, copying, distribution, or use of this transmission is strictly


° C-PATH press release: C-Path Launches CURE Drug Repurposing Collaboratory to Accelerate
Identification of Existing Drugs to Treat Infectious Diseases, Including COVID-19 (FDA-funded work, including an FDA
quote) - week of 6/8? [SP link]

° CDER: Virtual/remote human factor validation testing follow-up (internal reactive Q&A)

° OEA: Stakeholder toolkit for Convalescent Plasma, including fact sheet, tweets, and newsletter content
(some materials in toolkit now available in Spanish) - likely week of 6/8

° Drug Information Association (DIA) 2020 Virtual Global Annual Meeting: Regulatory Agility Under COVID
19 -Jeannie David (DSS) — 6/16

° SES: Dr. Hahn to provide opening remarks on call with American Hospital Association (membership
meeting about 700 members) - planning phase - 6/18

° MedDRA User's Group webinar: Impact of COVID-19 on pharmacovigilance, Sonja Brajovic (OSE) — 6/18
° RADM Araojo presenting (via pre-recorded video) on Under-representation in Clinical Trials and the

Implications for Drug Development, AACR Virtual Annual Meeting Il, including highlighting FDA OMHHE’s ongoing efforts
in response to COVID-19 [SP link - talking points] 6/22

. Internal:

° Updated Occupational Health employee QAs for InsideFDA in clearance

° Working on new employee QAs on workplace reopening; in development

° OCS: FDA IRB (Institutional Review Board) Interim Guidelines RE COVID-19 [SP link] ~6/11

Routine/daily/weekly activities:

. Daily - Prepared talking points for Commissioner Hahn for daily White House Task Force and press briefing

. Daily - Prepared/posted tweets/graphics on above topics for Commissioner and FDA accounts, and other social
media (e.g., Facebook, LinkedIn)

. Daily or as needed - updated PDFs listing EUAs for therapeutics and medical devices

. 2x/ weekly (Wed & Fri): COVID-19 response recap emails to stakeholders

. Weekly (Wed) - Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic
Tests

. Weekly (Wed): Coronavirus Q&As for Consumers — top Q&A of week email to Consumer Update list

. Ongoing internal: additional InsideFDA FAQs for employees for employees for InsideFDA, and responding to

questions received from HHS employee portal

Published yesterday, June 8

. Press statements:

° Daily roundup on topics including revisions to some respirator EUAs, a new guidance, a new ventilator
EUA, two new web pages, and a testing update

. Dr. Hahn media:

° HHS Learning Curve podcast: The FDA: Science in Action interview w/Dr. Hahn (6/5)

. Emergency Use Authorizations:

° Genetron Health (Beijing) Co., Ltd.; Genetron SARS-CoV-2 RNA Test (molecular)

° BioMedInnovations SuppleVent Ventilator added to Appendix B (note: don't see it added yet, but 6/8 DR
says added to 3/24 vent EUA)

. Web updates:

° New web page: Innovation to Respond to COVID-19 - Includes links to and descriptions of the new
partnerships FDA is leading or participating in to respond to COVID-19

° New web page: COVID-19 Educational Resources - Includes links to all the videos, fact sheets and social
media toolkits that FDA has created on COVID-19

° CDER: Sanitizing Tunnels QA - one external and one internal QA [SP link

. Stakeholders:

° CDER Guidance: Temporary Policy on Prescription Drug Marketing Act Requirements for Distribution of
Drug Samples During the COVID-19 Public Health Emergency

° FDA joined the Muscular Dystrophy Association for the MDA Advocacy Institute: A COVID-19 Discussion

with the FDA


Thanks!

From: Shah, Anand <Anand.Shah@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 10:35 AM

To: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum @fda.hhs.gov>;
Guram, Jeet <Jeet.Guram@fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi
<Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne *
<Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle <Dayle.Cristinzio@fda.hhs.gov>

Subject: RE: Comms Touch Base: HCQ

Totally agree — we will build all this in and send a revised version shortly

From: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 10:33 AM

To: Shah, Anand <Anand.Shah@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum@fda.hhs.gov>; Guram, Jeet
<Jeet.Guram @fda.hhs.govo; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>;
Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne * <Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle

<Dayle.Cristinzio@fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ

From: Shah, Anand <Anand.Shah@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 10:29 AM

To: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum @fda.hhs.gov>;
Guram, Jeet <Jeet.Guram@fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi
<Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne *
<Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle <Dayle.Cristinzio@fda.hhs.gov>

Subject: RE: Comms Touch Base: HCQ

All good feedback. Would like to emphasize that we do not regulate the (5S)

From: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 10:26 AM

To: Felberbaum, Michael <Michael.Felberbaum@fda.hhs.gov>; Shah, Anand <Anand.Shah@fda.hhs.gov>; Guram, Jeet
<Jeet.Guram @fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>;
Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne * <Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle
<Dayle.Cristinzio@fda.hhs.gov>

Subject: RE: Comms Touch Base: HCQ



Jeet Guram, M.D.
Senior Advisor, Office of the Commissioner
Food and Drug Administration

+1 (202) 230-0451 | jeet.guram@fda.hhs.gov

From: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 10:57 AM

To: Guram, Jeet <Jeet.Guram @fda.hhs.gov>; Shah, Anand <Anand.Shah@fda.hhs.gov>; Lenihan, Keagan
<keagan.Lenihan@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum@fda.hhs.gov>; Caliguiri, Laura
<Laura.Caliguiri@ fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie
<Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne * <Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle
<Dayle.Cristinzio@fda.hhs.gov>; Shreeve, Chris <Christine.Kuethe @fda.hhs.gov>

Cc: Clarke, Mary Beth <Marybeth.Clarke@fda.hhs.gov>

Subject: RE: Comms Touch Base: HCQ

Adding Chris Shreeve, who can make sure this goes through CDER clearance, DAV in particular since they wrote the
memo. | recommend that Don Beers also review.
Patrizia

From: Guram, Jeet <Jeet.Guram@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 10:53 AM

To: Shah, Anand <Anand.Shah@fda.hhs.gov>; Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Felberbaum, Michael
<Michael.felberbaum@fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi
<Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne *
<Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle <Dayle.Cristinzio@fda.hhs.gov>

Ce: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Clarke, Mary Beth <Marybeth.Clarke @fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ

Attaching the document as well

Jeet Guram, M.D.
Senior Advisor, Office of the Commissioner
Food and Drug Administration

+1 (202) 230-0451 | jeet.guram@fda.hhs.gov

From: Shah, Anand <Anand.Shah@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 10:52 AM

To: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum @fda.hhs.gov>;
Guram, Jeet <Jeet.Guram@fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi
<Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne *
<Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle <Dayle.Cristinzio@fda.hhs.gov>

Cc: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Clarke, Mary Beth <Marybeth.Clarke@fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ

+Patrizia and Mary Beth for awareness. Jeet will be reaching out to CDER shortly to help pull it all together
Anand

From: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>
Sent: Wednesday, June 17, 2020 10:39 AM


. Internal
. Meeting report-outs

SITREP

Published today, June 10
. Press statements:

° Daily roundup [input here]

° a

. Emergency Use Authorizations: these 3 are posting now

° Illumina, Inc.; Illumina COVIDSeq Test (molecular, first next-gen sequencing test)
° ChromaCode Inc.; HDPCR SARS-CoV-2 Assay (molecular)

° Warrior Diagnostics, Inc.; Warrior Diagnostics SARS-CoV-2 Assay (LDT)

. Web updates:

° a

. Stakeholders:

° Pre-tape for BIO (virtual) conference fireside chat with Dr. Hahn aired today (+ additional FDA speakers
presenting throughout the conference this week)

° MCMi weekly email update (PDF) ++LINK

° a

. Consumers & patients:

° a

. Internal

°

Likely today, June 10 [all internal confidential]

. Press statements:

° FDA Authorizes First Next Generation Sequence Test for Diagnosing COVID-19 [SP link] - (Illumina)

. Emergency Use Authorizations:

° Kaiser Permanente Mid-Atlantic home collection kit using Roche Cobas COVID-19 EUA assay — 6/9
update?

° Fulgent/Picture Genetics; Nasal swab home collection kit — 6/9 update?

. Web updates:

° CDRH: New Q&A: Hospital Beds, Stretchers, and Mattresses During the COVID-19 Public Health
Emergency [SP link] - 6/10

° CBER/ORA warning letter: Eucyt Laboratories, LLC, regarding products including an exosome product

fraudulently marketed as a treatment or prevention of COVID-19 (+ roundup) - issued 6/5, posting 6/9 update?
. Stakeholders:

° CDER/OTS Burst for Spotlight on CDER Science - Translating In Vitro Antiviral Activity to the In Vivo
Setting: A Crucial Step in Fighting COVID-19 [SP link] - OCC cleared

. Consumers & patients:

° FDA Voices: Rare Disease Therapy Development and Access Remain Top FDA Priorities During the Era of
COVID-19 [SP link] - likely 6/10

. Internal

°

Likely tomorrow, June 11 [all internal confidential]

. Press statements:
° Daily roundup
°

. Dr. Hahn media:


.

INTERNAL FDA USE ONLY

New web page: [ HYPERLINK “https://www.fda.gov/emergency-preparedness-and-
response/coronavirus-disease-2019-covid-19/covid-19-educational-resources" ] - Includes
links to all the videos, fact sheets and social media toolkits that FDA has created on COVID-
19

CDER: Sanitizing Tunnels QA - one [ HYPERLINK "https://www.fda.gov/drugs/information-
drug-class/qa-consumers-hand-sanitizers-and-covid-19" Jand one internal QA [[ HYPERLINK
"“http://sharepoint.fda.gov/orgs/OC-OCET/OCETdocs/nCoV/Shared%20Documents/JIC%20-
%20FDA%20IMG/CDER/REACTIVE%20QAs_disinfectant%20tunnels_CDER%20cleared.docx"
1]

Stakeholders:

°

CDER Guidance: [ HYPERLINK "https://www.fda.gov/regulatory-information/search-fda-
guidance-documents/temporary-policy-prescription-drug-marketing-act-requirements-
distribution-drug-samples-during-covid" ]

FDA [ HYPERLINK “https://twitter.com/US_FDA/status/126525 1336842473472" ] the
Muscular Dystrophy Association for the MDA Advocacy Institute: A COVID-19 [ HYPERLINK
"“https://forms.office.com/Pages/ResponsePage.aspx?id=GljAaRdcmkSXkLYKPH5SIrtTApbGw
-Dhk_Ix4uzAbRUNjY1WjgSNDBMMkU2MjhWWDBIMDRXUDIVUS4u" ] with the FDA
CDER: Revised coursework: [ HYPERLINK
"https://www.accessdata.fda.gov/cder/dr/course/framework/index.html" ]-OCC cleared,
not posting until 2021

CDER: Hand Sanitizer--new content for [ HYPERLINK
“https://www.fda.gov/drugs/information-drug-class/qa-consumers-hand-sanitizers-and-
covid-19" ] on disinfectant tunnels; update to main FDA FAQs; internal reactive QA [[
HYPERLINK “http://sharepoint.fda.gov/orgs/OC-
OCET/OCETdocs/nCoV/Shared%20Documents/JIC%20-
%20FDA%20IMG/CDER/Hand%20Sanitizer%20COVID%2019%20Guidances%20QA_UPDATES
_06.01.20.docx" ]] CDER - please confirm this is done - left the main FAQ update under
likely today

SES: Stakeholder call — Arthritis Foundation

SES: Stakeholder call — American College of Rheumatology

Oncology listening session on COVID

SITREP ENDS

MEETING REPORT OUT (see Op Tempo for dial-in #s)

[ HYPERLINK “http://sharepoint.fda.gov/orgs/OC-

OCET/OCETdocs/nCoV/default.aspx?RootFolder=%2Forgs%2FOC%2DOCET%2FOCETdocs%2FnCoV
%2FShared%20Documents%2FJIC%20%2D%20FDA%20IMG%2FOps%20meeting%20coverage&Fol
derCTID=0x012000A3A7A055F609174BBA12CCDSOBB2BD50&View=%7 bAASD576D-A152-4B9E-

B345-979F92F9C4C9%7d" ] updates (task forces, etc.)
Hearings/Hill briefings
NICCL calls (Tu/Th 10:15 a.m.)

MEDIA MONITORING

See daily a.m. JIC email from Andrea Takash

[PAGE \* MERGEFORMAT ]


From: Felberbaum, Michael <Michael.Felberbaum@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 10:21 AM

To: Shah, Anand <Anand.Shah@fda.hhs.gov>; Guram, Jeet <Jeet.Guram @fda.hhs.gov>; Lenihan, Keagan
<Keagan.Lenihan@fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi
<Heidi.Rebello@ fda.hhs.gov>; Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne *
<Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle <Dayle.Cristinzio@fda.hhs.gov>

Subject: RE: Comms Touch Base: HCQ

a
_
[
cs. | took a quick stab at

rearranging a bit.

From: Shah, Anand <Anand.Shah@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 10:03 AM

To: Guram, Jeet <Jeet.Guram @fda.hhs.gov>; Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Caliguiri, Laura
<Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie

<Stephanie.Caccomo@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum@fda.hhs.gov>; Pines, Wayne *

<Wayne.Pines@fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ

Great, thanks for the clarification. let’s get feedback from this group and then we can circulate wider

From: Guram, Jeet <Jeet.Guram @fda.hhs.gov>

Sent: Wednesday, June 17, 2020 10:02 AM

To: Shah, Anand <Anand.Shah@fda.hhs.gov>; Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Caliguiri, Laura
<Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie

<Stephanie.Caccomo@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum@fda.hhs.gov>; Pines, Wayne *

<Wayne.Pines@fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ

Thanks — just to clarify this has not been reviewed by CDER yet

Jeet Guram, M.D.
Senior Advisor, Office of the Commissioner
Food and Drug Administration

+1 (202) 230-0451 | jeet.guram@fda.hhs.gov

From: Shah, Anand <Anand.Shah@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 10:01 AM

To: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi
<Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Felberbaum, Michael
<Michael.felberbaum @fda.hhs.gov>; Pines, Wayne * <Wayne.Pines@fda.hhs.gov>; Guram, Jeet

<Jeet.Guram @fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ



. Enforcement Policy for Digital Health and Stimulation Therapeutic Devices for Physical
Rehabilitation — week of 6/15

. Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices
During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised) — week of 6/15

. Recalls of Medical Devices and Corrective Actions/Repairs of Electronic Products During
the Coronavirus Disease 2019 (COVID-19) Public Health Emergency — week of 6/15

. Enforcement Policy for Coagulation Systems for Measurement of Viscoelastic Properties
During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency — week of 6/15

. EUAs:

. Gravity Dx’s molecular LDT to the umbrella EUA

. Becton, Dickinson and Company, Veritor SARS-CoV-2 Assay

. Spectrum Solutions LLC, SDNA-1000 Saliva Collection Device

. Rapid Rona home collection kit using Hologic's Panther Fusion COVID-19 EUA assay

. Kaiser Permanente Mid-Atlantic home collection kit using Roche Cobas COVID-19 EUA
assay

. Additions to umbrella EUAs for various devices, ventilators, and support accessories

. CDER:

° Warning letter: Organic-beauty-recipes.com selling essential oils (from CDER ops sitrep - no date)

° Updated Remdesivir HealthCare Professional Fact Sheets — 6/12 or next week

° Revised EUA fact sheets for remdesivir, to update info on dosing and clinical trials, and add info on

HCQ/CQ drug interaction with remdesivir ~6/12 or week of 6/15

° Beyond this week:

. Guidance: COVID-19 infection in Employees in Pharmaceutical Manufacturing (+Daily Roundup,
listserv, reactive QAs) — late June

. Guidance: Manufacturing, Supply Chain, and Drug Inspections During COVID-19 Public Health
Emergency - Questions and Answers (+Daily Roundup) — late June

. Health Affairs Blog: CDER’s Contributions Towards Protecting Public Health During the COVID-19
Pandemic By Patrizia Cavazzoni, M.D. [SP link] - June/July

. CBER:

° Use of stem cells (comms and target date TBD)

. CFSAN:

° Checklist (w/CVM): Employee Health and Food Safety Checklist for Human and Animal Food Operations
During COVID-19 [SP link]

. CVM:

°

. ORA:

° Guidance: Disinfection of Surfaces on Interstate Conveyances (OMA clearance)

. OPLIA:

° Feature to go in ORAcle on ORA employee's experience being in India during pandemic and visiting
hydroxychloroquine plant [internal to ORA + external comms TBD]

. CTP:

° we

. Consumer & patient updates:

° Language translation of FAQs on face coverings and for DIY ventilator makers

° Getting Smarter About Food Safety: The Pandemic and Lessons Learned (based on similar FDA Voices)
. Web updates:

° OC/CDRH: User-friendly tool on website for labs that need information on test component substitutes
when supply issues arise (+ webinar)

° OCET: New page: Updates on activities performed under the rapid response to COVID-19 3D printing
MOU (w/NIH, VA) [SP link] ~maybe week of 6/8

. Stakeholders:

° Pharmaceutical Care Management Association (PCMA) webinar (Drs. Shah and Guram) 6/11 - TPs

forthcoming for JIC/OCC clearance (POC: Chaitali Patel)


INTERNAL FDA USE ONLY

See [ HYPERLINK "http://sharepoint.fda.gov/orgs/OC-
OCET/OCETdocs/nCoV/default.aspx?RootFolder=%2Forgs%2FOC%2DOCET%2FOCETdocs%2FnCoV
%2FShared%20Documents%2FJIC%20%2D%20FDA%20IMG%2FNICCL%20JIC%20%28interagency%
20comms%29&FolderCTID=0x012000A3A7A055F609174BBA12CCD50BB2BD50&View=%7bAASDS
76D-A152-4B9E-B345-979F92F9C4C9%7d" ] for social listening and other reports

HH

[PAGE \* MERGEFORMAT ]


<Michael.Felberbaum @fda.hhs.gov>; Pines, Wayne * <Wayne.Pines@fda.hhs.gov>; Guram, Jeet

<Jeet.Guram @fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ

Moving Steve to bcc

Dear All-

Following up from yesterday’s discussion, Jeet worked with CDER on a proposed statement that provides scientific
rationale for our decision.

We welcome your feedback.
Thank you

Anand

-----Original Appointment-----

From: Hahn, Stephen <SH1@fda.hhs.gov>

Sent: Monday, June 15, 2020 9:44 PM

To: Hahn, Stephen; Lenihan, Keagan; Shah, Anand; Caliguiri, Laura; Rebello, Heidi; Caccomo, Stephanie; Felberbaum,
Michael; Pines, Wayne *

Subject: Comms Touch Base: HCQ.

When: Tuesday, June 16, 2020 8:15 AM-8:30 AM (UTC-05:00) Eastern Time (US & Canada).

Where: (6)(G)llll ill


From: Guram, Jeet <Jeet.Guram@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 11:07 AM

To: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Shah, Anand <Anand.Shah@fda.hhs.gov>; Lenihan, Keagan
<Keagan.Lenihan@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum@fda.hhs.gov>; Caliguiri, Laura
<Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie
<Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne * <Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle
<Dayle.Cristinzio@fda.hhs.gov>; Shreeve, Chris <Christine.Kuethe@fda.hhs.gov>

Cc: Clarke, Mary Beth <Marybeth.Clarke@fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ

Jeet Guram, M.D.
Senior Advisor, Office of the Commissioner
Food and Drug Administration

+1 (202) 230-0451 | jeet.guram@fda.hhs.gov

From: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 10:57 AM

To: Guram, Jeet <Jeet.Guram @fda.hhs.gov>; Shah, Anand <Anand.Shah@fda.hhs.gov>; Lenihan, Keagan
<Keagan.Lenihan@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum@fda.hhs.gov>; Caliguiri, Laura
<Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie
<Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne * <Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle
<Dayle.Cristinzio@fda.hhs.gov>; Shreeve, Chris <Christine.Kuethe @fda.hhs.gov>

Ce: Clarke, Mary Beth <Marybeth.Clarke@fda.hhs.gov>

Subject: RE: Comms Touch Base: HCQ

Adding Chris Shreeve, who can make sure this goes through CDER clearance, DAV in particular since they wrote the
memo. | recommend that Don Beers also review.
Patrizia

From: Guram, Jeet <Jeet.Guram@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 10:53 AM

To: Shah, Anand <Anand.Shah@fda.hhs.gov>; Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Felberbaum, Michael
<Michael.Felberbaum @fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi
<Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne *
<Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle <Dayle.Cristinzio@fda.hhs.gov>

Cc: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Clarke, Mary Beth <Marybeth.Clarke @fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ

Attaching the document as well

Jeet Guram, M.D.
Senior Advisor, Office of the Commissioner
Food and Drug Administration

+1 (202) 230-0451 | jeet.guram@fda.hhs.gov


INTERNAL FDA USE ONLY

© FDA Authorizes First Next Generation Sequence Test for Diagnosing COVID-19 [[ HYPERLINK
"http://sharepoint.fda.gov/orgs/OC-OCET/OCETdocs/nCoV/Shared%20Documents/JIC%20-
%20FDA%20IMG/Press/For%20clearance/Illumina%20NGS%20testV2.docx" ]] - likely 6/9
Dr. Hahn media:
© 7:50-8:00 a.m. Bo Thompson morning show, Charlotte, NC
© 8:05-8:15 a.m. Drew Steele show, Fort Myers, FL
Emergency Use Authorizations:
©  Euroimmun; EURORealTime SARS-CoV-2 (molecular) auth. 6/8
© Siemens Healthcare Diagnostics Inc.; Dimension Vista SARS-CoV-2 Total antibody assay
(COV2T) (serology) auth. 6/8
© Siemens Healthcare Diagnostics Inc.; Dimension EXL SARS-CoV-2 Total antibody assay (CV2T)
(serology) auth. 6/8
Ow
Web updates:
co  CDER WL: Organic Beauty Products (issuing 6/8)
© CDER: disinfectant tunnels update to main FDA FAQs 6/9?
© CBER/ORA warning letter: Eucyt Laboratories, LLC, regarding products manufactured by the
firm including an exosome product fraudulently marketed as a treatment or prevention of
COVID-19 (+ roundup) issued 6/5, posting TBD (ORA checking status)
Stakeholders:
© CDRH: Webinar Series: SAVE THE DATE for next webinar on 6/23 shared via CDRH email
subscription
o  CFSAN: Support CDC guidance on farm workers and employers + stakeholder call ~6/9
Consumers & patients:
© FDA Voices: Rare Disease Therapy Development and Access Remain Top FDA Priorities
During the Era of COVID-19 [[ HYPERLINK "http://sharepoint.fda.gov/orgs/OC-
OCET/OCETdocs/nCoV/Shared%20Documents/JIC%20-
%20FDA%20IMG/Consumer/20200604%20FDA%20Voices%20ALS%20Rare%20disease%20J1
C.docx" ]] - likely 6/9 or 6/10
Internal
© InsideFDA: Face Shield Alternative to Face Mask for Medical Concerns [[ HYPERLINK
"“http://sharepoint.fda.gov/orgs/OC-OCET/OCETdocs/nCoV/Shared%20Documents/JIC%20-
%20FDA%20IMG/Internal%20comms/20200529%20-
%20Employee%20QA_Face%20Shield%20Alternative%20to%20Face%20Masks%20for%20M.
edical%20Concern.docx" ]]

Likely tomorrow, June 10 [all internal confidential]
Press statements:
© Daily roundup

Ow
Dr. Hahn media:
°
Emergency Use Authorizations:
Ow
Web updates:
Ow
Stakeholders:

[PAGE \* MERGEFORMAT ]


From: Shreeve, Chris

Sent: Wednesday, June 17, 2020 5:08 PM

To: Beers, Donald <Donald.Beers@fda.hhs.gov>

Cc: Clarke, Mary Beth <Marybeth.Clarke@fda.hhs.gov>; Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Cavazzoni,
Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Shah, Anand <Anand.Shah@fda.hhs.gov>; Felberbaum, Michael
<Michael.Felberbaum @fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi
<Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne *

<Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle <Dayle.Cristinzio@fda.hhs.gov>; Guram, Jeet <Jeet.Guram@fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ

Thank you, Don. We will get it through CDER as quickly as possible and then back to you.

Chris

From: Beers, Donald <Donald.Beers@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 4:42 PM

To: Shreeve, Chris <Christine.kKuethe @fda.hhs.gov>; Guram, Jeet <Jeet.Guram@fda.hhs.gov>

Cc: Clarke, Mary Beth <Marybeth.Clarke@fda.hhs.gov>; Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Cavazzoni,
Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Shah, Anand <Anand.Shah@fda.hhs.gov>; Felberbaum, Michael
<Michael.Felberbaum @fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi
<Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne *
<Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle <Dayle.Cristinzio@fda.hhs.gov>

Subject: RE: Comms Touch Base: HCQ

Chris,

lam glad to give my feedback now, but it would probably be good for me to look again if there are further revisions. |
have a couple of comments with potential edits on the last page of the attached.

Don

From: Shreeve, Chris <Christine.Kuethe@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 3:22 PM

To: Guram, Jeet <Jeet.Guram @fda.hhs.gov>

Cc: Clarke, Mary Beth <Marybeth.Clarke@fda.hhs.gov>; Beers, Donald <Donald.Beers@fda.hhs.gov>; Lenihan, Keagan
<Keagan.Lenihan@fda.hhs.gov>; Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Shah, Anand
<Anand.Shah@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum @fda.hhs.gov>; Caliguiri, Laura
<Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie
<Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne * <Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle

<Dayle.Cristinzio@fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ

Hi,
Just checking. Has this gone through CDER or will it go there after Don clears? Thanks!

Chris

Chris Shreeve
Director, Office of Communications

Center for Drug Evaluation and Research
U.S. Food and Drug Administration


To: Guram, Jeet <Jeet.Guram @fda.hhs.gov>; Shah, Anand <Anand.Shah@fda.hhs.gov>; Lenihan, Keagan
<Keagan.Lenihan@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum@fda.hhs.gov>; Caliguiri, Laura
<Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie
<Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne * <Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle
<Dayle.Cristinzio@fda.hhs.gov>; Shreeve, Chris <Christine.Kuethe@fda.hhs.gov>

Cc: Clarke, Mary Beth <Marybeth.Clarke@fda.hhs.gov>

Subject: RE: Comms Touch Base: HCQ

Adding Chris Shreeve, who can make sure this goes through CDER clearance, DAV in particular since they wrote the
memo. | recommend that Don Beers also review.
Patrizia

From: Guram, Jeet <Jeet.Guram @fda.hhs.gov>

Sent: Wednesday, June 17, 2020 10:53 AM

To: Shah, Anand <Anand.Shah@fda.hhs.gov>; Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Felberbaum, Michael
<Michael.Felberbaum@fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi
<Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne *
<Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle <Dayle.Cristinzio@fda.hhs.gov>

Ce: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Clarke, Mary Beth <Marybeth.Clarke@fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ.

Attaching the document as well

Jeet Guram, M.D.
Senior Advisor, Office of the Commissioner
Food and Drug Administration

+1 (202) 230-0451 | jeet.guram@fda.hhs.gov

From: Shah, Anand <Anand.Shah@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 10:52 AM

To: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum @fda.hhs.gov>;
Guram, Jeet <Jeet.Guram @fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi
<Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne *
<Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle <Dayle.Cristinzio@fda.hhs.gov>

Ce: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Clarke, Mary Beth <Marybeth.Clarke@fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ.

+Patrizia and Mary Beth for awareness. Jeet will be reaching out to CDER shortly to help pull it all together
Anand

From: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 10:39 AM

To: Shah, Anand <Anand.Shah@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum @fda.hhs.gov>; Guram, Jeet
<Jeet.Guram @fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>;
Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne * <Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle
<Dayle.Cristinzio@fda.hhs.gov>

Subject: RE: Comms Touch Base: HCQ.

Thanks!


From: (b) (6)

Sent: 8/7/2020 7:34:13 PM

To: CDER DRUG INFO [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=82081760a0544b00beS884dfcf1 f96cb-DRUGINFO]

ce: FDA Commissioner [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=1e34b2c290a94c4a8d7 af884727 cdOf8-Commissione]

Subject: Re: Hydroxychloroquine Emergency Use Authorization

Joy,

No, this information has not been helpful. This is probably somewhat of a typical automated response and, | think,
shows that no one there is the least bit concerned about saving lives. | hope | am wrong, but | also doubt that Dr. Hahn
even saw my original email. So sad!

The studies you refer to have mostly been discredited once peer reviewed. What about more recent studies in our
country that have shown good positive results. With all due respect, it is hard for me to understand why a person like Dr.
Hahn would not do some research of Hydroxychloroquine on his own and talk to the many, many Doctors and
healthcare professionals, (even other countries), who have used the drug a lot in early treatment, in the correct doses,
and in combination with other medications, having had tremendous success. | realize this is not the cure all, but it is
working for many. | have heard and read countless interviews and testimonies on the use of this treatment. | have heard
leading physicians, epidemiologists, and others who are using it and are completely baffled by the response of the FDA.
Many indicating the loss of life as a result of the FDA’s actions. Others saying if the FDA would publicly reverse their
statement or ban and allow this off label use, that thousands of lives would be saved. The statements | have heard are
not real recent, which to me means that thousands of lives have already been lost. | do not see how anyone could
honestly live with that. There are some pretty dark forces at work out there.

All | can do is to continue to pray that the Lord will open some eyes and hearts and do what is right for the American
people, and not succumb to the politicians, drug companies, and other forces. Yes, | believe that is what is happening, if
the truth were really known. Like | said in my previous email to Dr. Hahn, who is really controlling you?

So | ask, Dr. Hahn, “In Jesus Name”, please step up and do what you know in your
conscience is the right thing to do for the lives of many people.

| hope that you, Dr. Hahn, are able to read this response as well as my original email.
Thank you for your service to our country & “God Bless”,

9) (a concerned senior citizen from (6)\(6)

p.s. | feel so strongly, that | am including a complete copy of my previous email below:

My concerns about the FDA’s stance on Hydroxychloroquine

Dr. Hahn,

| do not know where to begin. | guess | am just very puzzled as to why You and others in the FDA, CDC, Dr. Fauci, are so
resistant to HC. It makes me wonder who is actually controlling you all. There are many others, but | refer you to the
following link and | hope you will read it in is entirety:

https://www.google.com/url?sa=t&rct=|&q=&esrc=s&source=web&cd=&ved=2ahUKEwiC_tHiwp3qAhXLFjQIHcA3Cz0QFj
ABegQIAhAB&url=https%3A%2F%2Fwww.statnews.com%2F2020%2F06%2F16%2Fhydroxychloroquine-emergency-use-
patients-politicians%2F&usg=AOvVaw3q79dhsXgEWo8TFfSzt20M

As a Doctor, | can not believe you are not aware of all the Doctors who are using HC along with other drugs
(Azithromycin, Zinc) with great success. | have seen so many interviews, of patients who have credited HC for saving
their lives, of Doctors who are using HC and with great success. (In many cases keeping patients out of the hospital and


Alison <Alison.Hunt@fda.hhs.gov>; Tantillo, Andrew <Andrew.Tantillo@fda.hhs.gov>; Gross, Karas
<Karas.Gross@fda.hhs.gov>; McBride, Maren <Maren.McBride@fda.hhs.gov>; Anderson, Erika
<Erika.Anderson@fda.hhs.gov>; Finnen, April <April.Finnen@fda.hhs.gov>; Cristinzio, Dayle
<Dayle.Cristinzio@fda.hhs.gov>; Walsh, Sandy <Sandy.Walsh@fda.hhs.gov>; Caliguiri, Laura
<Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>; Lynch, Sarah <Sarah.Lynch@fda.hhs.gov>;
Black, Jennifer <Jennifer.Black@fda.hhs.gov>; Meister, Karen G <Karen.Meister@fda.hhs.gov>; Alexander, Nicholas
<Nicholas.Alexander @fda.hhs.gov>; Sykes, LaShawn <LaShawn.Sykes@fda.hhs.gov>; Kimberly, Brad

<Brad.Kimberly @fda.hhs.gov>; Schipper, Jodi <jodi.schipper@fda.hhs.gov>; Morin, Steve <Steve.Morin@fda.hhs.gov>;
Cooper, Mildred <Mildred.Cooper@fda.hhs.gov>; Wohl, Alexander <Alexander.Wohl@fda.hhs.gov>; Mair, Michael
<Michael.Mair@fda.hhs.gov>; Sadove, Elizabeth <Elizabeth.Sadove@fda.hhs.gov>; Guevara, Bessy
<Bessy.Guevara@fda.hhs.gov>; Klimczak, Katherine <Katherine.Klimczak@fda.hhs.gov>; Van Pool, Kendall
<Kendall.VanPool@fda.hhs.gov>; Leggin, Brooke <Brooke.Leggin@fda.hhs.gov>; ODonnell, Allison

<Allison.ODonnell @fda.hhs.gov>; Pines, Wayne * <Wayne.Pines@fda.hhs.gov>; Roberts, Michelle
<Michelle.Roberts1@fda.hhs.gov>; Luebke, Yasemin <Yasemin.Luebke@fda.hhs.gov>; Hodnette, Jonathan
<Jonathan.Hodnette @fda.hhs.gov>; Campbell, Christopher <Christopher.Campbell@fda.hhs.gov>; Leboeuf, Andrew
<Andrew.Leboeuf@fda.hhs.gov>; Schumann, Katherine <Katherine.Schumann@fda.hhs.gov>; Walinsky, Sarah
<Sarah.Walinsky@fda.hhs.gov>; Kraus, Stefanie <Stefanie.Kraus@fda.hhs.gov>; Beers, Donald
<Donald.Beers@fda.hhs.gov>; Raza, Mark <Mark.Raza@fda.hhs.gov>; Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>;
Abram, Anna <Anna.Abram@fda.hhs.gov>; Shah, Anand <Anand.Shah@fda.hhs.gov>

Cc: Sipes, Grail <Grail.Sipes@fda.hhs.gov>; Farley, John <John.Farley@fda.hhs.gov>

Subject: RE: Plan for tomorrow: HCQ

The revocation letter and FAQs are now posted:

Revocation letter w/ memo attached: https://www.fda.gov/media/138945/download
EUA FAQs: https://www.fda.gov/media/138946/download

Updated EUA page: https://www ..fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
framework/emergency-use-authorization#tcoviddrugs

Jan Elicker

OEA Web and Digital Services Staff

Web posting lead

Joint Information Center (JIC)

2019 Novel Coronavirus (COVID-19) Incident Management Group (IMG)
office: 301-796-8416

cel: (6)(6)NN

From: Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>

Sent: Sunday, June 14, 2020 8:31 PM

To: Booze, Kristen <Kristen.Booze@fda.hhs.gov>; Baumgartner, Kristofer <Kristofer.Baumgartner @fda.hhs.gov>;
Shreeve, Chris <Christine.kKuethe@fda.hhs.gov>; Hunt, Alison <Alison.Hunt@fda.hhs.gov>; Tantillo, Andrew
<Andrew.Tantillo@fda.hhs.gov>; Gross, Karas <Karas.Gross@fda.hhs.gov>; McBride, Maren
<Maren.McBride@fda.hhs.gov>; Anderson, Erika <Erika.Anderson@fda.hhs.gov>; Finnen, April
<April.Finnen@fda.hhs.gov>; Cristinzio, Dayle <Dayle.Cristinzio@fda.hhs.gov>; Walsh, Sandy
<Sandy.Walsh@fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi
<Heidi.Rebello@fda.hhs.gov>; Lynch, Sarah <Sarah.Lynch@fda.hhs.gov>; Black, Jennifer Jennifer.Black@fda.hhs.gov>;
Meister, Karen G <Karen.Meister@fda.hhs.gov>; Alexander, Nicholas <Nicholas.Alexander@fda.hhs.gov>; Sykes,
LaShawn <LaShawn.Sykes@fda.hhs.gov>; Kimberly, Brad <Brad.Kimberly@fda.hhs.gov>; Schipper, Jodi
<jodi.schipper@fda.hhs.gov>; Morin, Steve <Steve.Morin@fda.hhs.gov>; Cooper, Mildred
<Mildred.Cooper@fda.hhs.gov>; Wohl, Alexander <Alexander.Woh|@fda.hhs.gov>; Mair, Michael
<Michael.Mair@fda.hhs.gov>; Sadove, Elizabeth <Elizabeth.Sadove@fda.hhs.gov>; Guevara, Bessy
<Bessy.Guevara@fda.hhs.gov>; Klimcezak, Katherine <Katherine.Klimczak@fda.hhs.gov>; Van Pool, Kendall



From: (b) (6), (b) (4)

Sent: 7/6/2020 2:24:43 PM

To: Shah, Anand [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=e2172ebbd96946c08e189fd612855f51-Anand.Shah]

Subject: HCQ EUA Revocation

Hi Dr Shah

Is the FDA planning to re-instate the EUA for HCQ in light of the Henry Ford Hospital system study?

| feel that the revocation of the HCQ EUA on 6/15/20 was questionable, since it was apparently based
on the VA-REACH study which included only 300 subjects, and the Oxford RECOVERY study which
did not publish the protocol for the HCG arm of the trial.

Thank you

(b) (6), (b) (4)


. Internal
° InsideFDA: Face Shield Alternative to Face Mask for Medical Concerns [SP link!

Likely tomorrow, June 10 [all internal confidential]
. Press statements:

° Daily roundup

° ws

. Dr. Hahn media:

° ws

. Emergency Use Authorizations:

° ws

. Web updates:

° ws

. Stakeholders:

° Pre-tape for BIO (virtual) conference fireside chat with Dr. Hahn will air 6/10
° MCMi weekly email update [SP link
° on

. Consumers & patients:

° on

. Internal

°

Pending release, week of June 8 and beyond [all internal confidential]

. Press statements:

° Daily roundups (M-F)

° FDA provides update on continuity of user fee related work for medical product reviews during
pandemic [SP link] - later week of 6/8

° FDA Provides Update on Foreign, Domestic Routine Inspections Across Products, Announces New
Approach to State Produce Inspections potentially ~6/9 [SP link

. Dr. Hahn media:

° Taping additional podcast footage 6/12 for new FDA podcast hosted by Dr. Shah (including COVID topics,
but will also cover a variety of other FDA topics; podcast name TBD)

. CDRH:

° Upcoming IIE guidances:

. Enforcement Policy for Viral Transport Media During the Coronavirus Disease 2019 (COVID-19)
Public Health Emergency ~week of 6/15

. Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications
—week of 6/8 or 6/15

. Enforcement Policy for Non-invasive Electrical Stimulation Devices Intended for Treatment of
Major Depressive Disorder (MDD) — week of 6/8 or 6/15

° EUAs:

° Web updates:

. WLs - Operation Fraud Alert - fraudulent COVID products (CDRH, Jeremy Kahn)~mid June or
later

. New Q&A: Hospital Beds, Stretchers, and Mattresses During the COVID-19 Public Health
Emergency [SP link] week of 6/8?

° Stakeholders:

. CDRH: Webinar series on PPE — 6/23

° Beyond this week:

. IIE guidances:


NYT is reviving the story it was looking to do a month or so ago about CQ/HCQ EUA — how it came to be, and now the
revocation. We should expect the story in the next day or so. Stacy, just flagging given this was the reporter you spoke
with previously, there will likely be mention of the emails from the Bright complaint. The reporter has all of the previous
comment/background we’d provided, which still stands, and ASPR had provided them comment/information as well. |
don’t expect the story to be anything we haven’t already seen written on this topic and as we noted, there have been a
number of comments, etc. provided to the reporter.

The reporter has followed up with a couple of specific questions (one which was answered by our online QA) but the

retaining Cs()(S) ltt? For

awareness, the reporter also noted that in an interview with her, Peter Navarro called this an action of "the deep state."
ASPA is aware and | will circle back.

Michael
Michael Felberbaum

Senior Advisor

Office of Media Affairs

Office of External Affairs

U.S. Food and Drug Administration
Tel: 240-402-9548 / Cel (0) (6)
michael.felberbaum@fda. gi

<image002.png>

<image004.jpg>
<image006.jpg>
<image008.jpg>
<image010.jpg>

<image012.jpg>


INTERNAL FDA USE ONLY

Stakeholder

Web
Social

Internal
Meeting report-outs

SITREP

Published today, June 17
Press statements:

°

°

Daily roundup on topics including ... [[ HYPERLINK "http://sharepoint.fda.gov/orgs/OC-
OCET/OCETdocs/nCoV/Shared%20Documents/JIC%20-
%20FDA%20IMG/Press/For%20clearance/2020.06.17.docx" ]]

Dr. Hahn media:

°

Emergency Use Authorizations:

°

Web updates:

°

Stakeholders:

°

MCMi weekly email update (PDF) ++LINK

Consumers & patients:

°

Internal

°

Likely today, June 17 [ail internal confidential]

Press statements:

°

°

FDA Issues Warning Letters to Companies Inappropriately Marketing Antibody Tests, Placing
Public Health at Risk [[ HYPERLINK "http://sharepoint.fda.gov/orgs/OC-
OCET/OCETdocs/nCoV/Shared%20Documents/JIC%20-
%20FDA%20IMG/Press/For%20clearance/20200612%20-
%20Test%20Warning%20Letters%20Press%20Release%20Draft%20v2.docx" J] (first WL
issued 6/10, but not yet posted - Medakit Ltd.; 4 WLs in this release) ~6/17

FDA quote in partner release (FDA-funded): C-Path Launches CURE Drug Repurposing
Collaboratory to Accelerate Identification of Existing Drugs to Treat Infectious Diseases,
Including COVID-19 + will be added to [ HYPERLINK “https://www.fda.gov/emergency-
preparedness-and-response/coronavirus-disease-2019-covid-19/innovation-respond-covid-
19" ] web page - [[ HYPERLINK "http://sharepoint.fda.gov/orgs/OC-
OCET/OCETdocs/nCoV/Shared%20Documents/JIC%20-
%20FDA%20IMG/Press/For%20clearance/CURE_PPP-Draft_PressRelease-
6%208%2020.docx" ]] likely ~6/17 (delayed for revisions/another OCC review)

Emergency Use Authorizations:

°

[PAGE \* MERGEFORMAT ]


. Enforcement Policy for Coagulation Systems for Measurement of Viscoelastic Properties
During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency — timing TBD

. EUAs:

. Becton, Dickinson and Company, Veritor SARS-CoV-2 Assay

. Spectrum Solutions LLC, SDNA-1000 Saliva Collection Device

. Fulgent/Picture Genetics; Nasal swab home collection kit - timing TBD

. Rapid Rona home collection kit using Hologic's Panther Fusion COVID-19 EUA assay -
timing TBD

. Additions to umbrella EUAs for various devices, ventilators, and support accessories

. CDER:

° Stakeholders:

. CDER guidance: Statistical Considerations for Clinical Trials During the COVID-19 Public Health
Emergency (+Daily Roundup, listserv messages [SP link]) - likely week of 6/15, later in week (in OMB clearance)

° Beyond this week:

. Guidance: COVID-19 infection in Employees in Pharmaceutical Manufacturing (+Daily Roundup,
listserv, reactive QAs) — late June

. Guidance: Manufacturing, Supply Chain, and Drug Inspections During COVID-19 Public Health
Emergency - Questions and Answers (+Daily Roundup) — late June

. Health Affairs Blog: CDER’s Contributions Towards Protecting Public Health During the COVID-19
Pandemic By Patrizia Cavazzoni, M.D. [SP link] - June/July

. CBER:

° Use of stem cells (comms and target date TBD)

° Updates on HCT/Ps - late week of 6/15, or week of 6/22

° Guidance on vaccines - timing TBD

. CFSAN:

° Checklist (w/CVM): Employee Health and Food Safety Checklist for Human and Animal Food Operations

During COVID-19 [SP link] mid-to-late June. Needs to go through HHS, OMB clearance after CDC posts testing guidance
(which is also in clearance)

° Working to clear a reactive statement RE: the salmon and cutting boards story out of China 6/16
. CVM:

°

. ORA:

° Guidance: Disinfection of Surfaces on Interstate Conveyances (in OMB clearance)

. OPLIA:

° Potentially a new blog by Europe office, emphasizing EU collaboration - week of 6/22 or later

° Feature on ORA employee's experience being in India during pandemic and visiting hydroxychloroquine
plant - possible FDA Voices - TBD on external comms

. CTP:

° we

. Consumer & patient updates:

Language translation of FAQs on face coverings and for DIY ventilator makers
Getting Smarter About Food Safety: The Pandemic and Lessons Learned (based on similar FDA Voices)
~week of 6/15

. Web updates:

° OC/CDRH: User-friendly tool on website for labs that need information on test component substitutes
when supply issues arise (+ webinar)

° OCET: New page: Updates on activities performed under the rapid response to COVID-19 3D printing
MOU (w/NIH, VA) [SP link - markup; SP link for OCC clearance] maybe ~6/18 or 6/19

° At-a-Glance PDF update 6/19

. Stakeholders:

° CDER: Virtual/remote human factor validation testing follow-up (internal reactive Q&A)


[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=01a6c20534774be590c50f0d455c81de-Katherine.K]; Van Pool, Kendall
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=db264f9a066044fc82aca6b12698467e-Kendall.Van]; Leggin, Brooke
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=c876a439c57d4d0abaa3c8898c803db3-Brooke.Legg]; ODonnell, Allison
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=d0cdfec1 12cf4f558f9650bc5591a898-Allison.ODo]; Pines, Wayne *
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=0e9f5ce0254041a48966c10d0c38bef5-Wayne.Pines]; Roberts, Michelle
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=e1c09da5d79049fb902729d7e8328a34-Michelle.Ro]; Luebke, Yasemin
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=10d526e5c46f47ce83978507a5365deS-Yasemin.Lue]; Hodnette, Jonathan
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=eea0ff4c9fe6418ea8bf16a891db85b9-Jonathan.Ho]; Campbell, Christopher
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=8e72b376d4a54dd08fcOf7ae915401d4-Christopher]; Leboeuf, Andrew
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=d35ec585598148118abdfd25f495c8f5-Andrew.Lebo]; Schumann, Katherine
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=c3e4251f58ae47b195422a2349b5e3ce-SCHUMANNK]; Walinsky, Sarah
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=97a2ad6b3c4549a78542fce1a086f7ea-Sarah.Walin]; Kraus, Stefanie
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=9d3959f3365b4fc39a7eb3245392 15bc-Stefanie.Kr]; Beers, Donald
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=d079bf15a01744bd94687d67 18ca4c42-Donald.Beer]; Raza, Mark
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=5811a7d72ee34aa78ff3c8ccb59f92ee-MRaza]; Lenihan, Keagan
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=ee7320ee8c184d66bfd521b0105d17d2-Keagan.Leni]; Abram, Anna
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=fb77660891384232a7cd9086fcbb1a3b-Anna.Abram]; Shah, Anand
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=e2172ebbd96946c08e189fd612855f51-Anand.Shah]

cc: Sipes, Grail [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=ccee8d18ee1f4a36885078f780c2f2f8-SIPESG]; Farley, John
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=d9dc8109c3ea49ed8f897ac979b0619b-FARLEYJ]

Subject: RE: Plan for tomorrow: HCQ

Thanks Jan. Resolving some last minute edits with HHS on PR. Will keep you posted on PR.

Stephanie Caccomo
Press Officer

Office of Media Affairs

Office of External Affairs

U.S. Food and Drug Administration
Desk: 301.348.1956

Cell: (5) GY
stephanie.caccomo@fda.hhs.gov

From: Elicker, Janet <Janet.Elicker@fda.hhs.gov>

Sent: Monday, June 15, 2020 11:08 AM

To: Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Booze, Kristen <Kristen.Booze@fda.hhs.gov>;
Baumgartner, Kristofer <Kristofer.Baumgartner@fda.hhs.gov>; Shreeve, Chris <Christine.Kuethe@fda.hhs.gov>; Hunt,


k. thanks.

From: Booze, Kristen <Kristen.Booze@fda.hhs.gov>
Sent: Sunday, June 14, 2020 12:30 PM

To: Sadove, Elizabeth <Elizabeth.Sadove@fda.hhs.gov>
Subject: RE: CDER EUA actions QAs

Most likely will be closer to 2pm. Sorry. |’ll send as soon as | have them back from CDER leadership.

From: Sadove, Elizabeth <Elizabeth.Sadove@fda.hhs.gov>
Sent: Saturday, June 13, 2020 10:38 PM

To: Booze, Kristen <Kristen.Booze@fda.hhs.gov>
Subject: Re: CDER EUA actions QAs

| can review around 1:00. Thanks for the heads up.

From: Booze, Kristen <Kristen.Booze@fda.hhs.gov>
Date: June 13, 2020 at 8:39:36 PM EDT

To: Sadove, Elizabeth <Elizabeth.Sadove@fda.hhs.gov>
Subject: CDER EUA actions QAs

Hi Liz,

I’m working on external QAs for the HCQ/CQ, EUA revocation. Andrew Leboeuf suggested that you review them before |
send them to OCC for final review.

The QAs will likely be cleared around 1 or 2pm tomorrow (Sunday) and then Ill send them to you, if you will be
available. We are working on a tight timeline to get them fully cleared by Monday morning. Will you be available to
review around that time? If not, |can send them to you for a review after OCC clears them, which will likely be much
later Sunday evening.

Thanks,
Kristen

Kristen Booze, MPH
Health Communications Specialist

Office of Communications, Division of Public Education and Outreach
Center for Drug Evaluation and Research

Office: (301) 796-7790 Mobile: (E)XG)NNNN

U.S. FOOD & DRUG

ADMINISTRATION

HooO-f


+1 (202) 230-0451 | jeet.guram@fda.hhs.gov

From: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>
Sent: Wednesday, June 17, 2020 10:57 AM

To: Guram, Jeet <Jeet.Guram @fda.hhs.gov>; Shah, Anand <Anand.Shah@fda.hhs.gov>; Lenihan, Keagan
<Keagan.Lenihan@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum@fda.hhs.gov>; Caliguiri, Laura
<Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie
<Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne * <Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle
<Dayle.Cristinzio@fda.hhs.gov>; Shreeve, Chris <Christine.Kuethe@fda.hhs.gov>

Cc: Clarke, Mary Beth <Marybeth.Clarke@fda.hhs.gov>

Subject: RE: Comms Touch Base: HCQ

Adding Chris Shreeve, who can make sure this goes through CDER clearance, DAV in particular since they wrote the
memo. | recommend that Don Beers also review.
Patrizia

From: Guram, Jeet <Jeet.Guram@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 10:53 AM

To: Shah, Anand <Anand.Shah@fda.hhs.gov>; Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Felberbaum, Michael
<Michael.Felberbaum @fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi
<Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne *
<Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle <Dayle.Cristinzio@fda.hhs.gov>

Cc: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Clarke, Mary Beth <Marybeth.Clarke@fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ

Attaching the document as well

Jeet Guram, M.D.
Senior Advisor, Office of the Commissioner
Food and Drug Administration

+1 (202) 230-0451 | ject.guram@fda.hhs.gov

From: Shah, Anand <Anand.Shah@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 10:52 AM

To: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum @fda.hhs.gov>;
Guram, Jeet <Jeet.Guram@fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi
<Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne *
<Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle <Dayle.Cristinzio@fda.hhs.gov>

Cc: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Clarke, Mary Beth <Marybeth.Clarke@fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ

+Patrizia and Mary Beth for awareness. Jeet will be reaching out to CDER shortly to help pull it all together
Anand

From: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>
Sent: Wednesday, June 17, 2020 10:39 AM
To: Shah, Anand <Anand.Shah@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum@fda.hhs.gov>; Guram, Jeet

<Jeet.Guram @fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>;
Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne * <Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle



Hi Everyone:
Thanks for your help and suggestions.
| left a VM with Janice Sheehy and spoke with Frank Olivarria.

Very respectfully,

LCDR Henry Allen, USPHS

Manager, Emergency Operations Center (EOC)
COVID-19 FDA Incident Management Group (IMG)
Office of Emergency Operations

Office of Emergency Management

U.S. Food and Drug Administration

Desk: 301-796-8444

Cell:

Fax: 301-847-8543,

Email: henry.allen@fda.hhs.gov
24 hour Emergency Number: 1-866-300-4374

try U.S. FOOD & DRUG

ADMINISTRATION

HOooOo- of

From: Hahn, Stephen <SH1@fda.hhs.gov>

Sent: Monday, June 15, 2020 12:29 PM

To: Allen, Henry <Henry.Allen@fda.hhs.gov>

Cc: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Russo, Mark <Mark.Russo@fda.hhs.gov>; Carter, Lionel
<Lionel.Carter@fda.hhs.gov>; Simms, Joshua <Joshua.Simms@fda.hhs.gov>; Sheehy, Janice

<Janice.Sheehy @fda.hhs.gov>; Olivarria, Frank <Frank.Olivarria@fda.hhs.gov>

Subject: Re: Please Call Dr. Peter Navarro at (B)(6) 9)

Call made. Thanks
Steve

From: "Allen, Henry" <Henry.Allen@fda.hhs.gov>

Date: Monday, June 15, 2020 at 12:17 PM

To: Stephen Hahn <SH1@fda.hhs.gov>

Cc: Keagan Lenihan <Keagan.Lenihan@fda.hhs.gov>, Mark Russo <Mark.Russo@fda.hhs.gov>, Lionel Carter
<Lionel.Carter@fda.hhs.gov>, "Simms, Joshua" <Joshua.Simms@fda.hhs.gov>, Janice Sheehy
<Janice.Sheehy @fda.hhs.gov>, Frank Olivarria <Frank.Olivarria@fda.hhs.gov>

Subject: RE: Please Call Dr. Peter Navarro at (b)(6) 9)

Adding Janice Sheehy and Frank Olivarria.
Very respectfully,

LCDR Henry Allen, USPHS

Manager, Emergency Operations Center (EOC)
COVID-19 FDA Incident Management Group (IMG)
Office of Emergency Operations

Office of Emergency Management

U.S. Food and Drug Administration

Desk: 301-796-8444

Cell: (OGM


From: Shah, Anand [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=E2172EBBD96946CO8E189FD612855F51-ANAND.SHAH]

Sent: 6/19/2020 3:26:06 PM

To: Guram, Jeet [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=ef73bea97e2b477b847ea302c47 30ccf-Gurjeet.Gur)

Subject: FW: Comms Touch Base: HCQ

See below —

Let me know when you have a draft for you and me to review together? We should aim to send this out to physicians on
Monday COB

From: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>
Sent: Friday, June 19, 2020 2:29 PM

To: Shah, Anand <Anand.Shah@fda.hhs.gov>

Subject: FW: Comms Touch Base: HCQ

FYSA — lets work with CDER on the front end of things so we don’t run into this issue. Pls reach out directly to Patrizia on
initial asks and she will help figure out the best way to put the info together.

From: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>
Sent: Friday, June 19, 2020 12:22 PM

To: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ

Patrizia

From: Shreeve, Chris <Christine.Kuethe@fda.hhs.gov>

Sent: Thursday, June 18, 2020 6:44 PM

To: Beers, Donald <Donald.Beers@fda.hhs.gov>

Cc: Clarke, Mary Beth <Marybeth.Clarke@fda.hhs.gov>; Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Cavazzoni,
Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Shah, Anand <Anand.Shah@fda.hhs.gov>; Felberbaum, Michael
<Michael.Felberbaum @fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi
<Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne *
<Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle <Dayle.Cristinzio@fda.hhs.gov>; Guram, Jeet <Jeet.Guram@fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ

Don,

Here is the document with Dr. Cavazzoni edits and ORP’s. Please let me know if you need anything further for your
review.


To: Shah, Anand <Anand.Shah@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum@fda.hhs.gov>; Guram, Jeet
<Jeet.Guram @fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>;
Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne * <Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle

<Dayle.Cristinzio@fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ

Thanks!

From: Shah, Anand <Anand.Shah@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 10:35 AM

To: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum @fda.hhs.gov>;
Guram, Jeet <Jeet.Guram@fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi
<Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne *
<Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle <Dayle.Cristinzio@fda.hhs.gov>

Subject: RE: Comms Touch Base: HCQ

Totally agree — we will build all this in and send a revised version shortly

From: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 10:33 AM

To: Shah, Anand <Anand.Shah@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum@fda.hhs.gov>; Guram, Jeet
<Jeet.Guram @fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>;
Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne * <Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle

<Dayle.Cristinzio@fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ.

From: Shah, Anand <Anand.Shah@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 10:29 AM

To: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum @fda.hhs.gov>;
Guram, Jeet <Jeet.Guram@fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi
<Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne *

<Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle <Dayle.Cristinzio@fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ

All good feedback. Would like to emphasize that we do not regulate the BYE) yyy

From: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>
Sent: Wednesday, June 17, 2020 10:26 AM
To: Felberbaum, Michael <Michael.Felberbaum @fda.hhs.gov>; Shah, Anand <Anand.Shah@fda.hhs.gov>; Guram, Jeet

<Jeet.Guram @fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>;
Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne * <Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle



INTERNAL FDA USE ONLY

© CDER: MedDRA User's Group webinar: Impact of COVID-19 on pharmacovigilance, Sonja
Brajovic (OSE) — 6/18
© SES: Dr. Hahn to provide opening remarks on call with American Hospital Association
(membership meeting about 700 members) - 6/18
Consumers & patients:
°
Internal
°

Pending release, week of June 15 and beyond [all internal confidential]
Press statements:
© Daily roundups (M-F)
© Inspection-related updates:
= Foreign inspections with update on drug UFAs ~ week of 6/15
= Foods interim update based on AFDO response, focus on food safety going into
summer season - maybe week of 6/15
= Domestic inspections update—as we have more clarity around resuming domestic
inspections, will provide - timing TBD (longer term)
Dr. Hahn media:
© Twitter Q&A initiative responses [[ HYPERLINK "http://sharepoint.fda.gov/orgs/OC-
OCET/OCETdocs/nCoV/Shared%20Documents/JIC%20-
%20FDA%20IMG/Social%20media/20200615Twitter%20QA%20Ep2%20v2.docx" ]]
CDRH:
© Upcoming IIE guidances:
= CDRH: Update to 506) guidance on device shortage reporting ~ 6/18 or 6/19
o- EUAs:

© Web updates:
= WLs - Operation Fraud Alert - fraudulent COVID products (CDRH, Jeremy Kahn)~mid
June or later
° Stakeholders:
= CDRH: Communications to alert HCPs on Certain COVID-19 Serology/Antibody Tests
Should Not Be Used (scope broadened beyond Phamatech) ~later week of 6/15, or
week of 6/22
= CDRH: New FAQ web page - Importing (+ Registration and Listing) Medical Devices
During the COVID-19 Pandemic [[ HYPERLINK "http://sharepoint.fda.gov/orgs/OC-
OCET/OCETdocs/nCoV/Shared%20Documents/JIC%20-
%20FDA%20IMG/CDRH/20200603%20COVID-
19%20FAQ%20IMPORTS%20clean%20final%200PEQ%20cleared%20edits%20from%2
ODICE.docx" }] “later week of 6/15, or week of 6/22
= CDRH: Webinar series on PPE (imported respirators) — next 6/23 (comms likely ~ 6/17)
© Beyond this week:
= IIE guidances:
= Enforcement Policy for Viral Transport Media During the Coronavirus Disease
2019 (COVID-19) Public Health Emergency ~week of 6/22 or later

[PAGE \* MERGEFORMAT ]


From: Guram, Jeet <Jeet.Guram @fda.hhs.gov>
Sent: Wednesday, June 17, 2020 3:20 PM

To: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Shah,
Anand <Anand.Shah@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum @fda.hhs.gov>; Caliguiri, Laura
<Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie
<Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne * <Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle
<Dayle.Cristinzio@fda.hhs.gov>; Shreeve, Chris <Christine.Kuethe@fda.hhs.gov>

Ce: Clarke, Mary Beth <Marybeth.Clarke@fda.hhs.gov>; Beers, Donald <Donald.Beers @fda.hhs.gov>

Subject: RE: Comms Touch Base: HCQ

No problem — looping in Don Beers as well, here is a first draft for review.

Jeet Guram, M.D.
Senior Advisor, Office of the Commissioner
Food and Drug Administration

+1 (202) 230-0451 | ject.guram@fda.hhs.gov

From: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>
Sent: Wednesday, June 17, 2020 11:23 AM

To: Guram, Jeet <Jeet.Guram @fda.hhs.gov>; Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Shah, Anand
<Anand.Shah@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum @fda.hhs.gov>; Caliguiri, Laura
<Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie
<Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne * <Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle
<Dayle.Cristinzio@fda.hhs.gov>; Shreeve, Chris <Christine.Kuethe@fda.hhs.gov>

Ce: Clarke, Mary Beth <Marybeth.Clarke@fda.hhs.gov>

Subject: RE: Comms Touch Base: HCQ

Thank you, Jeet.

From: Guram, Jeet <Jeet.Guram @fda.hhs.gov>

Sent: Wednesday, June 17, 2020 11:07 AM

To: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Shah, Anand <Anand.Shah@fda.hhs.gov>; Lenihan, Keagan
<Keagan.Lenihan@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum@fda.hhs.gov>; Caliguiri, Laura
<Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie
<Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne * <Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle
<Dayle.Cristinzio@fda.hhs.gov>; Shreeve, Chris <Christine.Kuethe @fda.hhs.gov>

Cc: Clarke, Mary Beth <Marybeth.Clarke@fda.hhs.gov>

Subject: RE: Comms Touch Base: HCQ.

Jeet Guram, M.D.
Senior Advisor, Office of the Commissioner
Food and Drug Administration

+1 (202) 230-0451 | jeet.guram@fda.hhs.gov


Biomedical Advanced Research and Development Authority

BARDA

Assistant Secretary for Preparedness and Response ASPR
Department of Health and Human Services

330 Independence Avenue, S.W. Room 640 G
Washington, D.C. 20201

Office: 202-260-0899

Mobile: Dora
Fax:
email (6)(6)/y nnn

Legally Privileged - This e-mail transmission and any documents attached to it may contain information that is legally
privileged. If you are not the intended recipient, or a person responsible for delivering this transmission to the intended
recipient, you are hereby notified that any disclosure, copying, distribution, or use of this transmission is strictly
prohibited. If you have received this transmission in error, please immediately notify the sender and destroy the original
transmission, attachments, and destroy any hard copies.

Note to contractors: nothing in this e-mail is intended to constitute contractual direction or to impact cost, price, or
schedule contained in the contract. If the contractor believes there is an impact, the contractor must disregard that
portion of the communication and contact the Contracting Officer for direction


<Dayle.Cristinzio@fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ

From: Felberbaum, Michael <Michael.Felberbaum@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 10:21 AM

To: Shah, Anand <Anand.Shah@fda.hhs.gov>; Guram, Jeet <Jeet.Guram@fda.hhs.gov>; Lenihan, Keagan
<Keagan.Lenihan@fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi
<Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne *

<Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle <Dayle.Cristinzio@fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ

From: Shah, Anand <Anand.Shah@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 10:03 AM

To: Guram, Jeet <Jeet.Guram @fda.hhs.gov>; Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Caliguiri, Laura
<Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie

<Stephanie.Caccomo@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum@fda.hhs.gov>; Pines, Wayne *

<Wayne.Pines@fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ

Great, thanks for the clarification. let’s get feedback from this group and then we can circulate wider

From: Guram, Jeet <Jeet.Guram@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 10:02 AM

To: Shah, Anand <Anand.Shah@fda.hhs.gov>; Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Caliguiri, Laura
<Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie

<Stephanie.Caccomo@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum@fda.hhs.gov>; Pines, Wayne *

<Wayne.Pines@fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ

Thanks — just to clarify this has not been reviewed by CDER yet

Jeet Guram, M.D.
Senior Advisor, Office of the Commissioner
Food and Drug Administration

+1 (202) 230-0451 | jeet.guram@fda.hhs.gov

From: Shah, Anand <Anand.Shah@fda.hhs.gov>
Sent: Wednesday, June 17, 2020 10:01 AM

To: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi
<Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Felberbaum, Michael



+Patrizia and Mary Beth for awareness. Jeet will be reaching out to CDER shortly to help pull it all together
Anand

From: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 10:39 AM

To: Shah, Anand <Anand.Shah@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum@fda.hhs.gov>; Guram, Jeet
<Jeet.Guram @fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>;
Caccomo, Stephanie <Stephanie.Caccomo @fda.hhs.gov>; Pines, Wayne * <Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle

<Dayle.Cristinzio@fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ,

Thanks!

From: Shah, Anand <Anand.Shah@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 10:35 AM

To: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum @fda.hhs.gov>;
Guram, Jeet <Jeet.Guram@fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi
<Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne *
<Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle <Dayle.Cristinzio@fda.hhs.gov>

Subject: RE: Comms Touch Base: HCQ

Totally agree — we will build all this in and send a revised version shortly

From: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 10:33 AM

To: Shah, Anand <Anand.Shah@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum@fda.hhs.gov>; Guram, Jeet
<Jeet.Guram @fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>;
Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne * <Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle

<Dayle.Cristinzio@fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ

From: Shah, Anand <Anand.Shah@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 10:29 AM

To: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum @fda.hhs.gov>;
Guram, Jeet <Jeet.Guram@fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi
<Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne *
<Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle <Dayle.Cristinzio@fda.hhs.gov>

Subject: RE: Comms Touch Base: HCQ

All good feedback. Would like to emphasize that we do not regulate (6S) yyy
fe


Legally Privileged - This e-mail transmission and any documents attached to it may contain information that is legally
privileged. If you are not the intended recipient, or a person responsible for delivering this transmission to the intended
recipient, you are hereby notified that any disclosure, copying, distribution, or use of this transmission is strictly
prohibited. If you have received this transmission in error, please immediately notify the sender and destroy the original
transmission, attachments, and destroy any hard copies.

Note to contractors: nothing in this e-mail is intended to constitute contractual direction or to impact cost, price, or
schedule contained in the contract. If the contractor believes there is an impact, the contractor must disregard that
portion of the communication and contact the Contracting Officer for direction


<Katherine.Klimczak@fda.hhs.gov>; Van Pool, Kendall <Kendall. VanPool@fda.hhs.gov>; Leggin, Brooke
<Brooke.Leggin@fda.hhs.gov>; ODonnell, Allison <Allison.ODonnell@fda.hhs.gov>; Pines, Wayne *
<Wayne.Pines@fda.hhs.gov>; Elicker, Janet <Janet.Elicker@fda.hhs.gov>; Roberts, Michelle

<Michelle.Roberts1@fda.hhs.gov>; Luebke, Yasemin <Yasemin.Luebke@fda.hhs.gov>; Hodnette, Jonathan
<Jonathan.Hodnette@fda.hhs.gov>; Campbell, Christopher <Christopher.Campbell@fda.hhs.gov>; Leboeuf, Andrew

<Andrew.Leboeuf@fda.hhs.gov>; Schumann, Katherine <Katherine.Schumann@fda.hhs.gov>; Walinsky, Sarah
<Sarah.Walinsky@fda.hhs.gov>,; Kraus, Stefanie <Stefanie.Kraus@fda.hhs.gov>; Beers, Donald
<Donald.Beers@fda.hhs.gov>; Raza, Mark <Mark.Raza@fda.hhs.gov>; Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>;
Abram, Anna <Anna.Abram @fda.hhs.gov>; Shah, Anand <Anand.Shah@fda.hhs.gov>

Cc: Sipes, Grail <Grail.Sipes@fda.hhs.gov>; Farley, John <John.Farley@fda.hhs.gov>

Subject: Plan for tomorrow: HCQ.

Hi all!

To sum up policy rollout:

Stephanie Caccomo
Press Officer

Office of Media Affairs

Office of External Affairs

U.S. Food and Drug Administration
Desk: 301.348.1956

Col: (B) (6
steph: mo@fda.hhs.qov

-----Original Appointment-----

From: Caccomo, Stephanie

Sent: Sunday, June 14, 2020 1:33 PM

To: Caccomo, Stephanie; Booze, Kristen; Baumgartner, Kristofer (Kristofer.Baumgartner@fda.hhs.gov); Shreeve, Chris;
Hunt, Alison; Tantillo, Andrew; Gross, Karas; McBride, Maren; Anderson, Erika; Finnen, April; Cristinzio, Dayle; Walsh,
Sandy; Caliguiri, Laura; Rebello, Heidi; Lynch, Sarah; Black, Jennifer; Meister, Karen G; Alexander, Nicholas; Sykes,
LaShawn; Kimberly, Brad; Schipper, Jodi; Morin, Steve; Cooper, Mildred; Wohl, Alexander; Mair, Michael
(Michael.Mair@fda.hhs.gov); Sadove, Elizabeth (Elizabeth.Sadove@fda.hhs.gov); Guevara, Bessy; Klimczak, Katherine;
Van Pool, Kendall; Leggin, Brooke; ODonnell, Allison; Pines, Wayne *; Elicker, Janet; Roberts, Michelle; Luebke, Yasemin;
Hodnette, Jonathan; Campbell, Christopher; Leboeuf, Andrew; Schumann, Katherine; Walinsky, Sarah; Kraus, Stefanie;
Beers, Donald; Raza, Mark; Lenihan, Keagan; Abram, Anna; Shah, Anand

Cc: Sipes, Grail; Farley, John

Subject: Quick check in on comms for tmrw--HCQ EUA

When: Sunday, June 14, 2020 8:00 PM-8:15 PM (UTC-05:00) Eastern Time (US & Canada).

Where: webex

INTERNAL DELIBERATIVE

Hi all—sorry to ping on a Sunday, but still lots of moving pieces. Let’s try to put CDER SMEs plus agency comms folks ona
call to nail down timing for tomorrow. Will cancel meeting if not needed.

Join by phone

Free

Access code: (6) (6)


Hi,
Just checking. Has this gone through CDER or will it go there after Don clears? Thanks!

Chris

Chris Shreeve
Director, Office of Communications

Center for Drug Evaluation and Research
U.S. Food and Drug Administration

Tel: 240-402-5772

ch reeve@fda hhs.gov

From: Guram, Jeet <Jeet.Guram @fda.hhs.gov>

Sent: Wednesday, June 17, 2020 3:20 PM

To: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Shah,
Anand <Anand.Shah@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum @fda.hhs.gov>; Caliguiri, Laura
<Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie
<Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne * <Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle
<Dayle.Cristinzio@fda.hhs.gov>; Shreeve, Chris <Christine. Kuethe@fda.hhs.gov>

Cec: Clarke, Mary Beth <Marybeth.Clarke@ fda.hhs.gov>; Beers, Donald <Donald.Beers@fda.hhs.gov>

Subject: RE: Comms Touch Base: HCQ

No problem — looping in Don Beers as well, here is a first draft for review.

Jeet Guram, M.D.
Senior Advisor, Office of the Commissioner
Food and Drug Administration

+1 (202) 230-0451 | jeet.guram@fda.hhs.gov

From: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 11:23 AM

To: Guram, Jeet <Jeet.Guram @fda.hhs.gov>; Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Shah, Anand
<Anand.Shah@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum @fda.hhs.gov>; Caliguiri, Laura
<Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie
<Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne * <Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle
<Dayle.Cristinzio@fda.hhs.gov>; Shreeve, Chris <Christine.Kuethe @fda.hhs.gov>

Cc: Clarke, Mary Beth <Marybeth.Clarke@fda.hhs.gov>

Subject: RE: Comms Touch Base: HCQ

Thank you, Jeet.

From: Guram, Jeet <Jeet.Guram @fda.hhs.gov>

Sent: Wednesday, June 17, 2020 11:07 AM

To: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Shah, Anand <Anand.Shah@fda.hhs.gov>; Lenihan, Keagan
<Keagan.Lenihan@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum@fda.hhs.gov>; Caliguiri, Laura
<Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie
<Stephanie.Caccomo @fda.hhs.gov>; Pines, Wayne * <Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle
<Dayle.Cristinzio@fda.hhs.gov>; Shreeve, Chris <Christine.Kuethe @fda.hhs.gov>



<Kendall.VanPool@fda.hhs.gov>; Leggin, Brooke <Brooke.Leggin@fda.hhs.gov>; ODonnell, Allison
<Allison.ODonnell @fda.hhs.gov>; Pines, Wayne * <Wayne.Pines@fda.hhs.gov>; Elicker, Janet
<Janet.Elicker@fda.hhs.gov>; Roberts, Michelle <Michelle.Roberts1@fda.hhs.gov>; Luebke, Yasemin
<Yasemin.Luebke@ fda.hhs.gov>; Hodnette, Jonathan <Jonathan.Hodnette @fda.hhs.gov>; Campbell, Christopher
<Christopher.Campbell@fda.hhs.gov>; Leboeuf, Andrew <Andrew.Leboeuf@fda.hhs.gov>; Schumann, Katherine
<Katherine.Schumann@fda.hhs.gov>; Walinsky, Sarah <Sarah.Walinsky@fda.hhs.gov>; Kraus, Stefanie
<Stefanie.Kraus@fda.hhs.gov>; Beers, Donald <Donald.Beers@fda.hhs.gov>; Raza, Mark <Mark.Raza@fda.hhs.gov>;
Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Abram, Anna <Anna.Abram@fda.hhs.gov>; Shah, Anand
<Anand.Shah@fda.hhs.gov>

Cc: Sipes, Grail <Grail.Sipes@fda.hhs.gov>; Farley, John <John.Farley@fda.hhs.gov>

Subject: Plan for tomorrow: HCQ.

Hi all!

To sum up policy rollout:

Stephanie Caccomo
Press Officer

Office of Media Affairs

Office of External Affairs

U.S. Food and Drug Administration
Desk: 301.348.1956

Cell: (6) (6)
steph: mo@fda.hhs.qov

-----Original Appointment-----

From: Caccomo, Stephanie

Sent: Sunday, June 14, 2020 1:33 PM

To: Caccomo, Stephanie; Booze, Kristen; Baumgartner, Kristofer (Kristofer.Baumgartner@fda.hhs.gov); Shreeve, Chris;
Hunt, Alison; Tantillo, Andrew; Gross, Karas; McBride, Maren; Anderson, Erika; Finnen, April; Cristinzio, Dayle; Walsh,
Sandy; Caliguiri, Laura; Rebello, Heidi; Lynch, Sarah; Black, Jennifer; Meister, Karen G; Alexander, Nicholas; Sykes,
LaShawn; Kimberly, Brad; Schipper, Jodi; Morin, Steve; Cooper, Mildred; Wohl, Alexander; Mair, Michael

(Michael. Mair@fda.hhs.gov); Sadove, Elizabeth (Elizabeth.Sadove@fda.hhs.gov); Guevara, Bessy; Klimczak, Katherine;
Van Pool, Kendall; Leggin, Brooke; ODonnell, Allison; Pines, Wayne *; Elicker, Janet; Roberts, Michelle; Luebke, Yasemin;
Hodnette, Jonathan; Campbell, Christopher; Leboeuf, Andrew; Schumann, Katherine; Walinsky, Sarah; Kraus, Stefanie;
Beers, Donald; Raza, Mark; Lenihan, Keagan; Abram, Anna; Shah, Anand

Cc: Sipes, Grail; Farley, John

Subject: Quick check in on comms for tmrw--HCQ EUA

When: Sunday, June 14, 2020 8:00 PM-8:15 PM (UTC-05:00) Eastern Time (US & Canada).

Where: webex

INTERNAL DELIBERATIVE

Hi all—sorry to ping on a Sunday, but still lots of moving pieces. Let’s try to put CDER SMEs plus agency comms folks ona
call to nail down timing for tomorrow. Will cancel meeting if not needed.

Join by phone
(CYC S Fo
(©)(6) E'S Toll Free
Access code: (b)(6))



From: Beers, Donald [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=D079BF15A01744BD94687D67 18CA4C42-DONALD.BEER]

Sent: 6/17/2020 5:46:15 PM

To: Clarke, Mary Beth [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=b0124a15b9344d8483929470fefa403a-CLARKEM]; Shreeve, Chris
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=571674b26ca64f578288f39264470299-Christine.K]

ce: Lenihan, Keagan [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=ee7320ee8c184d66bfd521b0105d17d2-Keagan.Leni]; Cavazzoni, Patrizia
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=c42abd33834044ecbaa03d075cc0aSd2-Patrizia.Ca]; Shah, Anand
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=e2172ebbd96946c08e189fd612855f51-Anand.Shah]; Felberbaum, Michael
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=4819a643ca2945cdb1a2631b83e69673-Michael.Fel]; Caliguiri, Laura
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=aa086f2d6c0346c49e996932d86ac62e-Laura.Calig]; Rebello, Heidi
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=2834ce193ca949799ef063e34a2cfa0b-Heidi.Rebel]; Caccomo, Stephanie
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=950c3 2cebc4b4f80b302c50cf31c8524-Stephanie.C]; Pines, Wayne *
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=0e9f5ce0254041a48966c10d0c38bef5-Wayne.Pines]; Cristinzio, Dayle
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=b5a8dc4e587946fa938714a962df4246-Dayle.Crist]; Guram, Jeet
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=ef73bea97e2b477b847ea302c4730ccf-Gurjeet.Gur]

Subject: RE: Comms Touch Base: HCQ

Mary Beth,

Don

From: Clarke, Mary Beth <Marybeth.Clarke@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 5:34 PM

To: Shreeve, Chris <Christine.Kuethe@fda.hhs.gov>; Beers, Donald <Donald.Beers@fda.hhs.gov>

Cc: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Shah, Anand
<Anand.Shah@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum @fda.hhs.gov>; Caliguiri, Laura
<Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie
<Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne * <Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle
<Dayle.Cristinzio@fda.hhs.gov>; Guram, Jeet <Jeet.Guram@fda.hhs.gov>

Subject: RE: Comms Touch Base: HCQ

Mary Beth

From: Shreeve, Chris <Christine.Kuethe@fda.hhs.gov>
Sent: Wednesday, June 17, 2020 5:08 PM
To: Beers, Donald <Donald.Beers@fda.hhs.gov>


From: Hinton, Denise [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=85FECAOBE0694803BE6030E97C7B4ADB-HINTOND]

Sent: 6/8/2020 2:21:57 PM

To: Mair, Michael [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=f45 11bdad7564d7fac7eadc7961467ab-Michael.Mai)}

Subject: RE: does the Commish know

No details — will call you later today...

From: Mair, Michael <Michael.Mair@fda.hhs.gov>
Sent: Monday, June 8, 2020 2:04 PM
To: Hinton, Denise <Denise.Hinton@fda.hhs.gov>
Subject: RE: does the Commish know

Assuming there r no issues or concerns...?

From: Hinton, Denise <Denise.Hinton@fda.hhs.gov>
Sent: Monday, June 8, 2020 1:04 PM

To: Mair, Michael <Michael.Mair@fda.hhs.gov>
Subject: RE: does the Commish know

Yes but said he'll circle back - no details

From: Mair, Michael <Michael.Mair@fda.hhs.gov>
Sent: Monday, June 8, 2020 12:57 PM

To: Hinton, Denise <Denise.Hinton@fda.hhs.gov>
Subject: does the Commish know

About the HCQ/CQ EUA revocation?


From: Hinton, Denise [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=85FECAOBE0694803BE6030E97C7B4ADB-HINTOND]

Sent: 6/15/2020 5:38:15 PM

To: Caccomo, Stephanie [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=950c32cebc4b4f80b302c50cf3 1c8524-Stephanie.C]

Subject: FW: WIRED Interview Request

FYSA.

Thanks,

Denise

From: Huckins, Grace <grace_huckins@wired.com>
Sent: Monday, June 15, 2020 5:10 PM

To: Hinton, Denise <Denise.Hinton@fda.hhs.gov>
Subject: WIRED Interview Request

Dear Admiral Hinton,

My name is Grace Huckins, and | am a writer on WIRED's science desk. | am currently working on a story about the FDA's
revocation of the EUA for hydroxychloroquine, and | was hoping that you might be available for comment. If you are free
to talk for about ten minutes any time before 10 AM PST tomorrow, it would be greatly appreciated. You can reach me
at 650-785-8539.

Thank you so much for your time,

Grace


Office of Chief Counsel
Cell: 240-381-3334


INTERNAL FDA USE ONLY

Updated Occupational Health employee QAs for InsideFDA in clearance

Working on new employee QAs on workplace reopening; in development

OCS: FDA IRB (Institutional Review Board) Interim Guidelines RE COVID-19 [[ HYPERLINK
"http://sharepoint.fda.gov/orgs/OC-OCET/OCETdocs/nCoV/Shared%20Documents/JIC%20-
%20FDA%20IMG/Other%20-
%20for%20clearance/20200605_OCS_IRB_interim_guidelines.docx" ]} ~6/11

Routine/daily/weekly activities:

Daily - Prepared talking points for Commissioner Hahn for daily White House Task Force and press
briefing

Daily - Prepared/posted tweets/graphics on above topics for Commissioner and FDA accounts, and
other social media (e.g., Facebook, LinkedIn)

Daily or as needed - updated PDFs listing EUAs for [ HYPERLINK
“https://www.fda.gov/media/136832/download" ] and [ HYPERLINK
"https://www.fda.gov/media/136702/download" ]

2x/ weekly ([ HYPERLINK "https://www.fda.gov/emergency-preparedness-and-response/about-
mcmi/mcmi-newsletters" ] & Fri): COVID-19 response recap emails to stakeholders

Weekly (Wed) - [ HYPERLINK "https://www.fda.gov/medical-devices/workshops-conferences-
medical-devices/virtual-town-hall-series-immediately-effect-guidance-coronavirus-covid-19-
diagnostic-tests-04012020" ]

Weekly (Wed): Coronavirus Q&As for Consumers — top Q&A of week email to Consumer Update
list

Ongoing internal: additional [ HYPERLINK
"“http://inside.fda.gov:9003/OC/OfficeofScientificMedicalPrograms/OfficeofCounter-
TerrorismandEmergingThreats/COVID-
19%20Information%20for%20FDA%20Staff/ucm646347.htm" \I "_blank" ] for employees for
InsideFDA, and responding to questions received from HHS employee portal

Published yesterday, June 8
Press statements:

© [HYPERLINK "https://www.fda.gov/news-events/press-announcements/coronavirus-covid-
19-update-daily-roundup-june-8-2020" ] on topics including revisions to some respirator
EUAs, a new guidance, a new ventilator EUA, two new web pages, and a testing update
Dr. Hahn media:
© HHS Learning Curve podcast: [ HYPERLINK "https://podcasts.apple.com/us/podcast/ep4-the-
fda-science-in-action/id1514670547?i=1000476974288" ] interview w/Dr. Hahn (6/5)
Emergency Use Authorizations:
©  Genetron Health (Beijing) Co., Ltd.; [ HYPERLINK
"https://www.fda.gov/media/138682/download" ] (molecular)
©  BioMedInnovations SuppleVent Ventilator added to [ HYPERLINK
"https://www.fda.gov/media/136528/download" ](note: don't see it added yet, but 6/8 DR
says added to 3/24 vent EUA)
Web updates:
co New web page: [ HYPERLINK “https://www.fda.gov/emergency-preparedness-and-
response/coronavirus-disease-2019-covid-19/innovation-respond-covid-19" ] - Includes links
to and descriptions of the new partnerships FDA is leading or participating in to respond to
COVID-19

[PAGE \* MERGEFORMAT ]


SITREP

Published today, June 9
. Press statements:

° Daily roundup on topics including ... finput here

° on

. Dr. Hahn media:

° 7:50-8:00 a.m. Bo Thompson morning show, Charlotte, NC

° 8:05-8:15 a.m. Drew Steele show, Fort Myers, FL

. Emergency Use Authorizations:

° a

. Web updates:

° a

. Stakeholders:

° CDRH: Webinar Series - Respirators for Health Care Personnel Use during COVID-19 Pandemic - first
event in series [slides - SP link]

° CDER: Division of Drug Information CURE ID webinar for HCPs - Capturing Clinician’s Experiences

Repurposing Drugs to Inform Future Studies in the Era of COVID-1 — Speaker Heather Stone (OMP) + outreach/SM/
webpage — 6/9

° CFSAN: Support CDC guidance on farm workers and employers + stakeholder call ~6/9

. Consumers & patients:

° FDA Voices: Rare Disease Therapy Development and Access Remain Top FDA Priorities During the Era of
COVID-19 [SP link] - likely 6/9 or 6/10

. Internal

° InsideFDA: Face Shield Alternative to Face Mask for Medical Concerns [SP link!

Likely today, June 9 [all internal confidential]
. Press statements:

° Daily roundup on topics including ... [input here

° FDA Authorizes First Next Generation Sequence Test for Diagnosing COVID-19 [SP link] - likely 6/9
. Dr. Hahn media:

° 7:50-8:00 a.m. Bo Thompson morning show, Charlotte, NC

° 8:05-8:15 a.m. Drew Steele show, Fort Myers, FL

. Emergency Use Authorizations:

° Euroimmun; EURORealTime SARS-CoV-2 (molecular) auth. 6/8

° Siemens Healthcare Diagnostics Inc.; Dimension Vista SARS-CoV-2 Total antibody assay (COV2T)
(serology) auth. 6/8

° Siemens Healthcare Diagnostics Inc.; Dimension EXL SARS-CoV-2 Total antibody assay (CV2T) (serology)
auth. 6/8

° on

. Web updates:

° CDER WL: Organic Beauty Products (issuing 6/8)

° CDER: disinfectant tunnels update to main FDA FAQs 6/9?

° CBER/ORA warning letter: Eucyt Laboratories, LLC, regarding products manufactured by the firm

including an exosome product fraudulently marketed as a treatment or prevention of COVID-19 (+ roundup) issued 6/5,
posting TBD (ORA checking status)

. Stakeholders:

° CDRH: Webinar Series: SAVE THE DATE for next webinar on 6/23 shared via CDRH email subscription

° CFSAN: Support CDC guidance on farm workers and employers + stakeholder call ~6/9

. Consumers & patients:

° FDA Voices: Rare Disease Therapy Development and Access Remain Top FDA Priorities During the Era of

COVID-19 [SP link] - likely 6/9 or 6/10


<Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle <Dayle.Cristinzio@fda.hhs.gov>; Guram, Jeet <Jeet.Guram@fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ.

Don,

Here is the document with Dr. Cavazzoni edits and ORP’s. Please let me know if you need anything further for your
review.

Thanks,
Chris

From: Shreeve, Chris

Sent: Wednesday, June 17, 2020 5:08 PM

To: Beers, Donald <Donald.Beers@fda.hhs.gov>

Cc: Clarke, Mary Beth <Marybeth.Clarke@fda.hhs.gov>; Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Cavazzoni,
Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Shah, Anand <Anand.Shah@fda.hhs.gov>; Felberbaum, Michael
<Michael.Felberbaum @fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi
<Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne *
<Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle <Dayle.Cristinzio@fda.hhs.gov>; Guram, Jeet <Jeet.Guram@fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ.

Thank you, Don. We will get it through CDER as quickly as possible and then back to you.

Chris

From: Beers, Donald <Donald.Beers@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 4:42 PM

To: Shreeve, Chris <Christine.Kuethe@fda.hhs.gov>; Guram, Jeet <Jeet.Guram @fda.hhs.gov>

Cc: Clarke, Mary Beth <Marybeth.Clarke@fda.hhs.gov>; Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Cavazzoni,
Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Shah, Anand <Anand.Shah@fda.hhs.gov>; Felberbaum, Michael
<Michael.Felberbaum @fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi
<Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne *
<Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle <Dayle.Cristinzio@fda.hhs.gov>

Subject: RE: Comms Touch Base: HCQ.

Chris,

lam glad to give my feedback now, but it would probably be good for me to look again if there are further revisions. |
have a couple of comments with potential edits on the last page of the attached.

Don

From: Shreeve, Chris <Christine.Kuethe@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 3:22 PM

To: Guram, Jeet <Jeet.Guram@fda.hhs.gov>

Cc: Clarke, Mary Beth <Marybeth.Clarke@fda.hhs.gov>; Beers, Donald <Donald.Beers@fda.hhs.gov>; Lenihan, Keagan
<Keagan.Lenihan@fda.hhs.gov>; Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Shah, Anand
<Anand.Shah@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum @fda.hhs.gov>; Caliguiri, Laura
<Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie
<Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne * <Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle
<Dayle.Cristinzio@fda.hhs.gov>

Subject: RE: Comms Touch Base: HCQ.



prohibited. If you have received this transmission in error, please immediately notify the sender and destroy the original
transmission, attachments, and destroy any hard copies.

Note to contractors: nothing in this e-mail is intended to constitute contractual direction or to impact cost, price, or
schedule contained in the contract. If the contractor believes there is an impact, the contractor must disregard that
portion of the communication and contact the Contracting Officer for direction


° CDER: Revised coursework: FDA's Role in Public Health: Drug Efficacy, Safety, Quality, and Beyond-OCC
cleared, not posting until 2021

° CDER: Hand Sanitizer--new content for FAQs on disinfectant tunnels; update to main FDA FAQs; internal
reactive QA [SP link] CDER - please confirm this is done - left the main FAQ update under likely today

° SES: Stakeholder call — Arthritis Foundation

° SES: Stakeholder call - American College of Rheumatology

° Oncology listening session on COVID

SITREP ENDS

MEETING REPORT OUT (see Op Tempo for dial-in #s)

. Standing meetings updates (task forces, etc.)

. Hearings/Hill briefings

. NICCL calls (Tu/Th 10:15 a.m.)

MEDIA MONITORING

. See daily a.m. JIC email from Andrea Takash

° See NICCL JIC folder for social listening and other reports
HHH

April Finnen

IMG JIC Section Chief

2019 Novel Coronavirus (COVID-19) Incident Management Group (IMG)
U.S. Food and Drug Administration

Cell: 240-507-7742 €Call this # or IM/Skype to reach me

JIC (Joint Information Center) leads email: 2019-nCoV-FDA-IMG-JIC-Leadership@fda.hhs.gov

U.S. FOOD & DRUG

ADMINISTRATION

BOooO- 8


Sent: 6/12/2020 6:31:29 PM

To: Sadove, Elizabeth [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=fd45c627000d4f34b9db362ff2b6af4b-SADOVEE]

Subject: RE: FOUO INFORMATION NOT RELEASABLE UNDER FOIA

Hi Liz,

From: Sadove, Elizabeth <Elizabeth.Sadove@fda.hhs.gov>

Sent: Friday, June 12, 2020 6:29 PM

To: Hinton, Denise <Denise.Hinton@fda.hhs.gov>

Subject: FW: FOUO INFORMATION NOT RELEASABLE UNDER FOIA

This is the revocation letter for the hydroxy/chloroquine EVA. (Ey ys
LS ee

From: Beers, Donald <Donald.Beers@fda.hhs.gov>

Sent: Friday, June 12, 2020 5:46 PM

To: Sadove, Elizabeth <Elizabeth.Sadove@fda.hhs.gov>; Leboeuf, Andrew <Andrew.Leboeuf@fda.hhs.gov>
Cc: Mair, Michael <Michael.Mair@fda.hhs.gov>; Sipes, Grail <Grail.Sipes@fda.hhs.gov>; Farley, John
<John.Farley@fda.hhs.gov>

Subject: RE: FOUO INFORMATION NOT RELEASABLE UNDER FOIA

Thanks, Liz. For anyone who has not yet viewed this, | have added my revision to the footnote to the version Liz
provided in the attached. (If you have already marked up the previous version, you can send me that.)

Please let me know if you have any comments or if you will not have comments, | guess at least by tomorrow morning.
Liz and Andrew, who else will need to review this before it is finalized for signature on Monday?

Andrew, do you have a sense of when you might have the memo to be enclosed ready for review?

Don << File: Hydroxy revocation db 4 40.doc >>

From: Sadove, Elizabeth <Elizabeth.Sadove@fda.hhs.gov>

Sent: Friday, June 12, 2020 4:27 PM

To: Beers, Donald <Donald.Beers@fda.hhs.gov>; Leboeuf, Andrew <Andrew.Leboeuf@fda.hhs.gov>

Cc: Mair, Michael <Michael.Mair@fda.hhs.gov>; Walinsky, Sarah <Sarah.Walinsky@fda.hhs.gov>; Schumann, Katherine

<Katherine.Schumann@fda.hhs.gov>; Sipes, Grail <Grail.Sipes@fda.hhs.gov>; Farley, John <John.Farley@fda.hhs.gov>
Subject: RE: FOUO INFORMATION NOT RELEASABLE UNDER FOIA

Thanks Don- | made a couple of small edits for consistency (6)(5)) yyy) throughout. Thanks.
<< File: Hydroxy revocation db.doc >>


From: Lenihan, Keagan [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=EE7320EE8C184D66BFD521B0105D17D2-KEAGAN. LENI]

Sent: 6/19/2020 4:05:48 PM

To: Shah, Anand [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=e2172ebbd96946c08e189fd612855f51-Anand.Shah]

Subject: RE: Comms Touch Base: HCQ.

No problem.

From: Shah, Anand <Anand.Shah@fda.hhs.gov>
Sent: Friday, June 19, 2020 3:25 PM

To: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ

Will definitely do — and thanks for the feedback this afternoon

From: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>
Sent: Friday, June 19, 2020 2:29 PM

To: Shah, Anand <Anand.Shah@fda.hhs.gov>

Subject: FW: Comms Touch Base: HCQ.

FYSA — lets work with CDER on the front end of things so we don’t run into this issue. Pls reach out directly to Patrizia on
initial asks and she will help figure out the best way to put the info together.

From: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>
Sent: Friday, June 19, 2020 12:22 PM

To: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ

Patrizia

From: Shreeve, Chris <Christine.Kuethe@fda.hhs.gov>

Sent: Thursday, June 18, 2020 6:44 PM

To: Beers, Donald <Donald.Beers@fda.hhs.gov>

Cc: Clarke, Mary Beth <Marybeth.Clarke@fda.hhs.gov>; Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Cavazzoni,

Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Shah, Anand <Anand.Shah@fda.hhs.gov>; Felberbaum, Michael
<Michael.Felberbaum @fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi

<Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne *

<Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle <Dayle.Cristinzio@fda.hhs.gov>; Guram, Jeet <Jeet.Guram@fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ.

Don,

Here is the document with Dr. Cavazzoni edits and ORP’s. Please let me know if you need anything further for your
review.


INTERNAL FDA USE ONLY

Web updates:
© Main FAQ edits/updates from CDER [[ HYPERLINK "http://sharepoint.fda.gov/orgs/OC-
OCET/OCETdocs/nCoV/Shared%20Documents/JIC%20-
%20FDA%20IMG/Web/For%20clearance/General%20FAQs/20200616_FAQ_CDER_Updates.
docx" J]
° -
Stakeholders:
© OEA: Stakeholder toolkit for Convalescent Plasma, including fact sheet, tweets, and
newsletter content (some materials in toolkit now available in Spanish) - likely “6/17
© CFSAN: Foods program calls with states, to raise particular issues/challenges the industry is
experiencing and to identify potential solutions - calls to begin 6/17 [[ HYPERLINK
"http://sharepoint.fda.gov/orgs/OFVM/OFVMExecSec/OEPReview/Shared%20Documents/C
OVID-
19/Industry%20info/Processed%20Fruit%20%20Veg%20Industry%20Request%2006122020.
pptx" ] - slides]
°
Consumers & patients:
© Weekly consumer update FAQ email, on COVID-19 treatments, and proper use of
disinfectants [[ HYPERLINK "http://sharepoint.fda.gov/orgs/OC-
OCET/OCETdocs/nCoV/Shared%20Documents/JIC%20-
%20FDA%20IMG/Consumer/20200616FAQemail.docx" ]]
Internal
°

Likely tomorrow, June 18 [all internal confidential]
Press statements:
© Daily roundup
© FDA Takes Additional Action to Harness Real-World Data to Inform COVID-19 Response
Efforts [[ HYPERLINK “http://sharepoint.fda.gov/orgs/OC-
OCET/OCETdocs/nCoV/Shared%20Documents/JIC%20-
%20FDA%20IMG/Press/For%20clearance/Diagnostics%20Accelerator%20PR%206%2015%2
020.docx" ]] + FDA quote in Reagan-Udall Foundation release [[ HYPERLINK
"http://sharepoint.fda.gov/orgs/OC-OCET/OCETdocs/nCoV/Shared%20Documents/JIC%20-
%20FDA%20IMG/Press/For%20clearance/Diagnostics%20Evidence%20Accelerator%20RUF%
20Draft%206%2015%2020.docx" }] - 6/18, ~10:00 a.m.

° ane
Dr. Hahn media:
°
Emergency Use Authorizations:
° oo
Web updates:
Own
Stakeholders:
©  CDER: CURE ID discussion at International Society for Neglected Tropical Diseases [
HYPERLINK “https://www.isntd.org/isntd-connect" J—- Heather Stone (OMP) [ HYPERLINK
"http://sharepoint.fda.gov/orgs/OC-OCET/OCETdocs/nCoV/Shared%20Documents/JIC%20-
%20FDA%20IMG/CDER/CURE_ISNTD%20Webinar_6.16.2020.pptx" ]] 6/18

[PAGE \* MERGEFORMAT ]


From: Booze, Kristen <Kristen.Booze@fda.hhs.gov>
Sent: Wednesday, June 24, 2020 4:56 PM

To: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>
Cc: Shreeve, Chris <Christine.Kuethe@fda.hhs.gov>

Subject: FW: Review requested of remarks for Dr. Shah on chloroquine and Hydroxychloroquine -- BY 6 pm today
Importance: High

Hi Dr. Cavazzoni,

CDER was asked to review these talking points regarding the HCQ/CQ EUA revocation.

OND-Policy, OID, OMP and ORP have all edited and cleared the talking points — their edits and comments are in
SharePoint. We wanted to allow you the chance to look at their edits before stating they are CDER cleared. They’re due

at 6pm today.

http://sharepoint.fda.gov/orgs/OC-
OCET/OCETdocs/nCoV/Shared%20Documents/SH%20talking%20points/2020-06-
26%20Shah%20remarks%20for%20stakeholder%20call%200n%20HQ.1.docx

Many thanks,
Kristen

From: Wohl, Alexander <Alexander.Woh!|@fda.hhs.gov>

Sent: Wednesday, June 24, 2020 10:08 AM

To: 2019-nCoV FDA IMG JIC CDER <2019-nCoVFDAIMGJICCDER @fda.hhs.gov>; 2019-nCoV FDA IMG JIC Leadership
<2019-nCoV-FDA-IMG-JIC-Leadership@fda.hhs.gov>

Cc: Fritsch, Beth F. <Beth.Fritsch@fda.hhs.gov>; Cristinzio, Dayle <Dayle.Cristinzio@fda.hhs.gov>
Subject: Review requested of remarks for Dr. Shah on chloroquine and Hydroxychloroquine -- BY 6 pm today

Good morning JIC CDER and JIC Leadership teams,

Attached for your review and comments are draft opening remarks to be given by Dr. Shah to an upcoming
stakeholder call with the autoimmune community to explain the scientific basis behind the revocation
of emergency use authorizations for chloroquine and hydroxychloroquine.

If you could provide your edits and comments by 6 pm this evening that would be greatly appreciated. Please
make any edits in the SharePoint document below:

http://sharepoint.fda.gov/orgs/OC-
OCET/OCETdocs/nCoV/Shared%20Documents/SH%20talking%20points/2020-06-
26%20Shah%20remarks%20for%20stakeholder%20call%200n%20HQ.1.docx

Thanks,

Alex


EUA, the request for and revocation of the EUA, the donation of HCQ to the SNS, and the disposition of
HCQ from the SNS after the EUA was revoked.

During the course of any lawsuit, the opposing party may use the discovery process to obtain agency records about the
allegations related to the case. The law requires FDA to preserve such information in whatever form it is generated and
maintained. Therefore, the agency requires your assistance to preserve documents and other evidence, including
electronic data, in connection with the subject of these lawsuits.

As an FDA employee, you are required to preserve all documents and data related to the subject of these lawsuits,
including information stored in hard copy, on computer systems, on removable or portable electronic storage media,
and on your personal computer, if used to create agency records. All electronically stored data, including e-mails and
other electronic communication, word processing documents, spreadsheets, databases, calendars, telephone voice
mails, and other kinds of media, must be retained until resolution of this matter. In addition, you must retain non-
electronic documents and evidence in whatever form, including personal or desk files, calendars, notes,
correspondence, and other things relevant to the case. Any routine data destruction policies related to these records
must be discontinued until further notice from me.

You do not need to collect and produce the documents/electronic data at this time; rather, we are only seeking
to preserve and prevent the destruction of existing information. Failure to preserve and retain information may
result in sanctions against the agency. Consequently, if you are unsure whether certain information should be
preserved, err on the side of caution and preserve the information until you have discussed the issue with [indicate who
should be contacted]. If production of some or all of the material is required at a later date, you will receive further
instructions from an attorney assigned to this matter. Also, if you have any questions about how to preserve
electronically stored information, please contact me.

Although you are not required to collect documents/electronic data at this time, where possible, it is advisable
to segregate potentially relevant information. This can help ensure it is not inadvertently destroyed (e.g., by operation
of an electronic system or according to prior record retention policies) and can facilitate ease of retrieval if production
becomes necessary.

In addition, please make sure that this message is distributed to all personnel in your office who may be involved
in, or have information pertaining to, this lawsuit. Because this message is confidential, however, do not send it outside
the agency without first discussing it with me or an attorney from my office. Please send me the names of the people
to whom you forward this message. | also advise that you document the specific actions taken by you and your office in
response to this message.

If you or your office have in your possession, custody, or control any documents/electronic data within the
category described above, or if you are responsible for an office that has any documents/electronic data, you must
preserve and retain the information through the time that you are either instructed to collect it or informed that the
preservation instruction is no longer in effect. As stated above, no documents/electronic data need be collected or
produced at this point.

Please click the “yes” voting button above to confirm that you have received this notice, understand your obligations,
and agree to comply with the instructions.

If you have any questions about your obligations to preserve information, please contact Susan Williams at

Susan.Williams@fda.hhs.gov.


SITREP

Published today, June 17
. Press statements:

° Daily roundup on topics including ... [add input!
° ws

. Dr. Hahn media:

° a

. Emergency Use Authorizations:

° a

. Web updates:

° a

. Stakeholders:

° MCMi weekly email update (PDF) ++LINK
. Consumers & patients:

° ws

. Internal

°

Likely today, June 17 [all internal confidential]

. Press statements:

° FDA Issues Warning Letters to Companies Inappropriately Marketing Antibody Tests, Placing Public
Health at Risk [SP link] (first WL issued 6/10, but not yet posted - Medakit Ltd.; 4 WLs in this release) ~6/17

° FDA quote in partner release (FDA-funded): C-Path Launches CURE Drug Repurposing Collaboratory to

Accelerate Identification of Existing Drugs to Treat Infectious Diseases, Including COVID-19 + will be added to innovation
web page - [SP link] likely ~6/17 (delayed for revisions/another OCC review)

° on

. Emergency Use Authorizations:

° on

. Web updates:

° Main FAQ edits/updates from CDER [SP link]

° on

. Stakeholders:

° OEA: Stakeholder toolkit for Convalescent Plasma, including fact sheet, tweets, and newsletter content
(some materials in toolkit now available in Spanish) - likely ~6/17

° CFSAN: Foods program calls with states, to raise particular issues/challenges the industry is experiencing
and to identify potential solutions - calls to begin 6/17 [SP link - slides]

° a

. Consumers & patients:

° Weekly consumer update FAQ email, on COVID-19 treatments, and proper use of disinfectants [SP link
. Internal

°

Likely tomorrow, June 18 [all internal confidential]

. Press statements:

° Daily roundup

° FDA Takes Additional Action to Harness Real-World Data to Inform COVID-19 Response Efforts [SP link] +
FDA quote in Reagan-Udall Foundation release [SP link] - 6/18, ~10:00 a.m.

° a

. Dr. Hahn media:

°

. Emergency Use Authorizations:


°

Emergency Use Authorizations:

.
° a

. Web updates:

° ws

. Stakeholders:

° Pharmaceutical Care Management Association (PCMA) webinar (Drs. Shah and Guram) 6/11 (POC:
Chaitali Patel) - recorded 6/9

° ws

. Consumers & patients:

° ws

. Internal

° OCS: FDA IRB (Institutional Review Board) Interim Guidelines RE COVID-19 [SP link] ~6/11 (OCC has
cleared)

Pending release, week of June 8 and beyond [all internal confidential]

. Press statements:
° Daily roundups (M-F)
° FDA Provides Update on Foreign, Domestic Routine Inspections Across Products, Announces New

Approach to State Produce Inspections [SP link] and update on continuity of user fee related work for medical product
reviews during pandemic [SP link] -- on hold pending senior leadership discussions / may be combined

° CDRH statement on bundle of WLs to test kit manufacturers - later week of 6/8, or week of 6/15

. Dr. Hahn media:

° Taping additional podcast footage 6/12 for new FDA podcast hosted by Dr. Shah (including COVID topics,
but will also cover a variety of other FDA topics; podcast name TBD)

. CDRH:

° Upcoming IIE guidances:

.

° EUAs:

. ane

° Web updates:

. WLs - Operation Fraud Alert - fraudulent COVID products (CDRH, Jeremy Kahn)~mid June or
later

° Stakeholders:

. CDRH: Webinar series on PPE — next 6/23

° Beyond this week:

. IIE guidances:

. Enforcement Policy for Viral Transport Media During the Coronavirus Disease 2019
(COVID-19) Public Health Emergency ~week of 6/15 or later

. Recalls of Medical Devices and Corrective Actions/Repairs of Electronic Products During
the Coronavirus Disease 2019 (COVID-19) Public Health Emergency — week of 6/15 or 6/22

. Enforcement Policy for Coagulation Systems for Measurement of Viscoelastic Properties
During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency — week of 6/15

. Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee
Applications — week of 6/22

. Enforcement Policy for Non-invasive Electrical Stimulation Devices Intended for
Treatment of Major Depressive Disorder (MDD) — week of 6/22

. Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices
During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised) — week of 7/5

. Enforcement Policy for Digital Health and Stimulation Therapeutic Devices for Physical
Rehabilitation — week of 7/5

. EUAs:

. Becton, Dickinson and Company, Veritor SARS-CoV-2 Assay


From: Hinton, Denise [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=85FECAOBE0694803BE6030E97C7B4ADB-HINTOND]

Sent: 6/15/2020 4:53:31 PM

To: Mair, Michael [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=f45 11bdad7564d7fac7eadc7961467ab-Michael.Mai)

Subject: RE: Please Call Dr. Peter Navarro at (b)(6)))

| want

From: Mair, Michael <Michael.Mair@fda.hhs.gov>

Sent: Monday, June 15, 2020 4:18 PM

To: Hinton, Denise <Denise.Hinton@fda.hhs.gov>
Subject: RE: Please Call Dr. Peter Navarro at (B)(6) I)

If u want — no big deal to me — just letting u know

From: Hinton, Denise <Denise.Hinton@fda.hhs.gov>
Sent: Monday, June 15, 2020 4:17 PM
To: Mair, Michael <Michael.Mair@fda.hhs.gov>

Subject: RE: Please Call Dr. Peter Navarro at (B)(6) 7)

Will do some reconnaissance....

From: Mair, Michael <Michael.Mair@fda.hhs.gov>

Sent: Monday, June 15, 2020 3:25 PM

To: Hinton, Denise <Denise.Hinton@fda.hhs.gov>
Subject: RE: Please Call Dr. Peter Navarro at (b)(6) 0)

Not so far as | know — request for Commis to call passed along and he made call — all he said was “call made”

From: Hinton, Denise <Denise.Hinton@fda.hhs.gov>
Sent: Monday, June 15, 2020 3:24 PM

To: Mair, Michael <Michael.Mair@fda.hhs.gov>

Subject: RE: Please Call Dr. Peter Navarro at (6) (6)

Does Tom have any details?

From: Mair, Michael <Michael.Mair@fda.hhs.gov>

Sent: Monday, June 15, 2020 3:22 PM

To: Hinton, Denise <Denise.Hinton@fda.hhs.gov>

Subject: FW: Please Call Dr. Peter Navarro at (BY)

Wonder if was related to revocation of CQ/HCQ EUA...

From: Allen, Henry <Henry.Allen@fda.hhs.gov>
Sent: Monday, June 15, 2020 12:36 PM
To: Russo, Mark <Mark.Russo@fda.hhs.gov>; Carter, Lionel <Lionel.Carter@fda.hhs.gov>; Simms, Joshua

<Joshua.Simms@fda.hhs.gov>; Mair, Michael <Michael.Mair@fda.hhs.gov>; Mignone, Alfred
<Alfred.Mignone@fda.hhs.gov>

Subject: RE: Please Call Dr. Peter Navarro at (b)(6))


° RADM Araojo presenting (via pre-recorded video) on Under-representation in Clinical Trials and the
Implications for Drug Development, AACR Virtual Annual Meeting II, including highlighting FDA OMHHE’s ongoing efforts
in response to COVID-19 [SP link - talking points] 6/22

. Internal:

° Updated Occupational Health employee QAs for InsideFDA in clearance (w/OO)

° Working on new employee QAs on workplace reopening; in development

° Updates to Occupational Health InsideFDA page, including updated clinic visit questionnaire [SP

link] and new social distancing flier for internal use

° InsideF DA: Face Shield Alternative to Face Mask for Medical Concerns [SP link] - holding for reopening
FDA plan

Routine/daily/weekly activities:

. Daily - Prepared talking points for Commissioner Hahn for daily White House Task Force and press briefing

. Daily - Prepared/posted tweets/graphics on above topics for Commissioner and FDA accounts, and other social
media (e.g., Facebook, LinkedIn)

. Daily or as needed - updated PDFs listing EUAs for therapeutics and medical devices

. 2x/ weekly (Wed & Fri): COVID-19 response recap emails to stakeholders

° Weekly (Wed) - Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic
Tests

. Weekly (Wed): Coronavirus Q&As for Consumers — top Q&A of week email to Consumer Update list

. Ongoing internal: additional InsideFDA FAQs for employees for employees for InsideFDA, and responding to

questions received from HHS employee portal

Published yesterday, June 16

. Press statements:
° Daily roundup on topics including web FAQ updates on a new medical device adverse event reporting

web page, a serology test EUA revocation, updated templates for developers that intend their assay to be used for
pooling patient samples or for screening asymptomatic individuals, and a testing update

° FDA Revokes Emergency Use Authorization for Chembio Antibody Test

° Facilitating Diagnostic Test Availability for Asymptomatic Testing and Sample Pooling (w/CDRH web
updates)

. Emergency Use Authorizations:

° Technical Safety Services LLC; Technical Safety Services VHP Decontamination System (~6/13)

° Oceanetics, Inc.; Negative-pressure Respiratory System with Advanced Ventilation Return (NRSAVR-100)
(~6/13)

° Kaiser Permanente Mid-Atlantic States; KPMAS COV|D-19 Test (molecular; home collection kit)

° Applied BioCode Inc.; BioCode SARS-CoV-2 Assay (molecular)

° Emory Medical Laboratories, Emory University Hospital; SARS-CoV-2 RBD |gG (serological)

° EUA revocation: Chembio Diagnostic System, Inc.; DPP COVID-19 IgM/IgG System - revocation letter

Web updates:
CDRH: Asymptomatic Testing Updates to testing FAQ, updated molecular diagnostic EUA templates
EUA archive page updates: device EUAs, all archived EUAs
Stakeholders:
CDER: Drug Information Association (DIA) 2020 Virtual Global Annual Meeting: Regulatory Agility Under
COVID 19 - Jeannie David (DSS)

of o0e

SITREP ENDS


Guram, Jeet <Jeet.Guram@fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi
<Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne *

<Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle <Dayle.Cristinzio@fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ

All good feedback. Would like to emphasize that we do not regulate the (YS) yyy
|

From: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>
Sent: Wednesday, June 17, 2020 10:26 AM

To: Felberbaum, Michael <Michael.Felberbaum @fda.hhs.gov>; Shah, Anand <Anand.Shah@fda.hhs.gov>; Guram, Jeet
<Jeet.Guram @fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>;
Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne * <Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle

<Dayle.Cristinzio@fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ

From: Felberbaum, Michael <Michael.Felberbaum@fda.hhs.gov>
Sent: Wednesday, June 17, 2020 10:21 AM
To: Shah, Anand <Anand.Shah@fda.hhs.gov>; Guram, Jeet <Jeet.Guram@fda.hhs.gov>; Lenihan, Keagan

<Keagan.Lenihan@fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi
<Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne *

<Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle <Dayle.Cristinzio@fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ

CC) a)
|
————_,_,_!::>—eoeoommmmeeeeeeoeo)
Se -
(1 took a quick stab at

rearranging a bit.

From: Shah, Anand <Anand.Shah@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 10:03 AM

To: Guram, Jeet <Jeet.Guram @fda.hhs.gov>; Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Caliguiri, Laura
<Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie

<Stephanie.Caccomo@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum@fda.hhs.gov>; Pines, Wayne *

<Wayne.Pines@fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ

Great, thanks for the clarification. let’s get feedback from this group and then we can circulate wider

From: Guram, Jeet <Jeet.Guram@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 10:02 AM

To: Shah, Anand <Anand.Shah@fda.hhs.gov>; Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Caliguiri, Laura
<Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie

<Stephanie.Caccomo@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum@fda.hhs.gov>; Pines, Wayne *



INTERNAL FDA USE ONLY

© Pre-tape for BIO (virtual) conference [ HYPERLINK “https://www.bio.org/events/bio-
digital/sessions/677784" ] with Dr. Hahn will air 6/10

© MCMi weekly email update [[ HYPERLINK "http://sharepoint.fda.gov/orgs/OC-
OCET/OCETdocs/nCoV/Shared%20Documents/JIC%20-
%20FDA%20IMG/Stakeholders/For%20clearance/20200610_MCMiemail.docx" }]

°

Consumers & patients:
°

Internal
°

Pending release, week of June 8 and beyond [all internal confidential]
Press statements:

© Daily roundups (M-F)

o FDA provides update on continuity of user fee related work for medical product reviews
during pandemic [[ HYPERLINK "http://sharepoint.fda.gov/orgs/OC-
OCET/OCETdocs/nCoV/Shared%20Documents/JIC%20-
%20FDA%20IMG/Press/For%20clearance/draft%20user%20fee%20update%205.27.20.docx"
]] - later week of 6/8

© FDA Provides Update on Foreign, Domestic Routine Inspections Across Products, Announces
New Approach to State Produce Inspections potentially ~6/9 [[ HYPERLINK
"“http://sharepoint.fda.gov/orgs/OC-OCET/OCETdocs/nCoV/Shared%20Documents/JIC%20-
%20FDA%20IMG/Press/For%20clearance/FDA%20Inspections_6.6.20.docx" ]]

Dr. Hahn media:
© Taping additional podcast footage 6/12 for new FDA podcast hosted by Dr. Shah (including
COVID topics, but will also cover a variety of other FDA topics; podcast name TBD)
CDRH:
© Upcoming IIE guidances:
= Enforcement Policy for Viral Transport Media During the Coronavirus Disease 2019
(COVID-19) Public Health Emergency ~week of 6/15
= Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee
Applications — week of 6/8 or 6/15
= Enforcement Policy for Non-invasive Electrical Stimulation Devices Intended for
Treatment of Major Depressive Disorder (MDD) — week of 6/8 or 6/15
o  EUAs:

© Web updates:
= WLs - Operation Fraud Alert - fraudulent COVID products (CDRH, Jeremy Kahn)~mid
June or later
= New Q&A: Hospital Beds, Stretchers, and Mattresses During the COVID-19 Public
Health Emergency [[ HYPERLINK "http://sharepoint.fda.gov/orgs/OC-
OCET/OCETdocs/nCoV/Shared%20Documents/JIC%20-
%20FDA%20IMG/CDRH/FAQS%20HOSPITAL%20BEDS%20AND%20STRETCHERS%200P
EQ%20CLEARED.docx" ]] week of 6/8?
° Stakeholders:
= CDRH: Webinar series on PPE — 6/23
© Beyond this week:

[PAGE \* MERGEFORMAT ]


+1 (202) 230-0451 | jeet.guram@fda.hhs.gov

From: Shah, Anand <Anand.Shah@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 10:01 AM

To: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi
<Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie <Stephanie.Caccomo @fda.hhs.gov>; Felberbaum, Michael
<Michael.Felberbaum @fda.hhs.gov>; Pines, Wayne * <Wayne.Pines@fda.hhs.gov>; Guram, Jeet

<Jeet.Guram @fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ

Moving Steve to bcc
Dear All—

Following up from yesterday’s discussion, Jeet worked with CDER on a proposed statement that provides scientific
rationale for our decision.

We welcome your feedback.
Thank you

Anand

oo Original Appointment-----

From: Hahn, Stephen <SH1@fda.hhs.gov>

Sent: Monday, June 15, 2020 9:44 PM

To: Hahn, Stephen; Lenihan, Keagan; Shah, Anand; Caliguiri, Laura; Rebello, Heidi; Caccomo, Stephanie; Felberbaum,
Michael; Pines, Wayne *

Subject: Comms Touch Base: HCQ.

When: Tuesday, June 16, 2020 8:15 AM-8:30 AM (UTC-05:00) Eastern Time (US & Canada).

Where: (6) (6) ill


[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=c876a439c5 7d4d0abaa3c8898c803db3-Brooke.Legg]; ODonnell, Allison
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=dOcdfec112cf4f558f9650bc5591a898-Allison.ODo]; Pines, Wayne *
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=0e9f5ce0254041a48966c10d0c38befS-Wayne Pines]; Elicker, Janet
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=88e18144ad424b8398b 1 fdfe&Sféde5b-JElicker]; Roberts, Michelle
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=e1c09da5d79049fb902729d7e8328a34-Michelle.Ro]; Luebke, Yasemin
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=10d526e5c46f47ce83978507a5365deS-Yasemin. Lue]; Hodnette, Jonathan
{/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=eea0ff4c9fe6418ea8bf16a891db85b9-Jonathan.Ho]; Campbell, Christopher
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=8e7 2b37 6d4a54dd08fc0f7ae915401d4-Christopher]; Kraus, Stefanie
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=9d3959f3365b4fc39a7eb3245392 15bc-Stefanie.Kr]; Lenihan, Keagan
(/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=ee7320ee8c184d66bfd521b0105d17d2-Keagan.Leni]; Abram, Anna
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=fb77660891384232a7cd9086fcbb1a3b-Anna.Abram]; Shah, Anand
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=e2172ebbd96946c08e189fd612855f51-Anand.Shah]

cc: Lee, Marguerite [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=6e40a857adef4a7587b7 1992d79809e0-Marguerite.]; Wanke, Hilary
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=3595b19b65eb4cdcb19e5c4f7dc11706-Hilary. Wank]; Helms Williams, Emily
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=87 3be46f1b1a4d2b8df3fe67137cbdc8-HELMSWILLIA]; Litigation Hold
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=4ae774ddb5d84977aac503990e4b37 10-Litigation]; OP Policy Review Team
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=880566a7249e4495973f695 7997d7031-OP Policy R]; Williams, Susan
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=63c605573234410491fad54cde597ecd-Susan. Willi]

Subject: ACTION REQUIRED: Retention of records relating to EUA for HCQ/CCQ

All:

Please be advised that a lawsuit has been filed in the United States District Court for the Western District of
Michigan challenging the now-revoked emergency use authorization (EUA) for hydroxychloroquine sulfate and
chloroquine phosphate (HCQ/CQ). The suit was filed by the Association of American Physicians and Surgeons against
FDA, Commissioner Hahn, the Biomedical Advanced Research and Development Authority (BARDA), Acting Director
Disbrow, the Department of Health and Human Services, and Secretary Azar. The Plaintiff makes allegations about the
circumstances surrounding the issuance and revocation of the EUA and the HCQ in the Strategic National Stockpile
(SNS). Plaintiff asks the court to order the Defendants to distribute HCQ from the stockpile promptly to members of the
public who have valid prescriptions and to enjoin the Defendants from placing any restrictions on HCQ .

While this litigation is pending, the agency is under an obligation to retain documents and communications, including
emails and other electronically stored information, that are potentially relevant to the case. Such documents and
communications include, but are not limited to:

Documents, electronically stored information, and tangible items that were considered, directly or
indirectly, during the decision-making process in connection with the request for and issuance of the


From: Shreeve, Chris [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=571674B26CA64F5 78288F392644 70299-CHRISTINE.K]
Sent: 6/18/2020 11:53:01 AM

To: Guram, Jeet [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=ef73bea97e2b477b847ea302c47 30ccf-Gurjeet.Gur)
cc: Clarke, Mary Beth [/o=ExchangeLabs/ou=Exchange Administrative Group

(FYDIBOHF23SPDLT)/cn=Recipients/cn=b0124a15b9344d8483929470fefa403a-CLARKEM]; Lenihan, Keagan
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=ee7320ee8c184d66bfd521b0105d17d2-Keagan.Leni]; Cavazzoni, Patrizia
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=c42abd33834044ecbaa03d075cc0a5d2-Patrizia.Ca]; Shah, Anand
{/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=e2172ebbd96946c08e189fd612855f51-Anand.Shah]; Felberbaum, Michael
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=4819a643ca2945cdb1a2631b83e69673-Michael.Fel]; Caliguiri, Laura
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=aa086f2d6c0346c49e996932d86ac62e-Laura.Calig]; Rebello, Heidi
(/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=2834ce193ca949799ef063e34a2cfa0b-Heidi.Rebel]; Caccomo, Stephanie
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=950c3 2cebc4b4f80b302c50cf31c8524-Stephanie.C]; Pines, Wayne *
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=0e9f5ce0254041a48966c10d0c38befS-Wayne.Pines]; Cristinzio, Dayle
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=b5a8dc4e587946fa9387 14a962df4246-Dayle.Crist]; Beers, Donald
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=d079bf15a01744bd94687d67 18ca4c42-Donald.Beer)

Subject: RE: Comms Touch Base: HCQ

Just want you to know that this is in CDER clearance and we hope to have it to Don later today.

Chris

From: Beers, Donald <Donald.Beers@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 4:42 PM

To: Shreeve, Chris <Christine.Kuethe@fda.hhs.gov>; Guram, Jeet <Jeet.Guram@fda.hhs.gov>

Cc: Clarke, Mary Beth <Marybeth.Clarke@fda.hhs.gov>; Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Cavazzoni,
Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Shah, Anand <Anand.Shah@fda.hhs.gov>; Felberbaum, Michael
<Michael.felberbaum @fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi

<Heidi.Rebello@ fda.hhs.gov>; Caccomo, Stephanie <Stephanie.Caccomo @fda.hhs.gov>; Pines, Wayne *
<Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle <Dayle.Cristinzio@fda.hhs.gov>

Subject: RE: Comms Touch Base: HCQ

Chris,

lam glad to give my feedback now, but it would probably be good for me to look again if there are further revisions. |
have a couple of comments with potential edits on the last page of the attached.

Don

From: Shreeve, Chris <Christine.Kuethe@fda.hhs.gov>
Sent: Wednesday, June 17, 2020 3:22 PM
To: Guram, Jeet <Jeet.Guram @fda.hhs.gov>


From: Guram, Jeet <Jeet.Guram@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 3:20 PM

To: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Shah,
Anand <Anand.Shah@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum @fda.hhs.gov>; Caliguiri, Laura
<Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie
<Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne * <Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle
<Dayle.Cristinzio@fda.hhs.gov>; Shreeve, Chris <Christine.Kuethe@fda.hhs.gov>

Cc: Clarke, Mary Beth <Marybeth.Clarke@fda.hhs.gov>; Beers, Donald <Donald.Beers@fda-hhs.gov>

Subject: RE: Comms Touch Base: HCQ

No problem — looping in Don Beers as well, here is a first draft for review.

Jeet Guram, M.D.
Senior Advisor, Office of the Commissioner
Food and Drug Administration

+1 (202) 230-0451 | jeet.guram@fda.hhs.gov

From: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 11:23 AM

To: Guram, Jeet <Jeet.Guram@fda.hhs.gov>; Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Shah, Anand
<Anand.Shah@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum @fda-hhs.gov>; Caliguiri, Laura
<Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie
<Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne * <Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle
<Dayle.Cristinzio@fda.hhs.gov>; Shreeve, Chris <Christine.Kuethe@fda.hhs.gov>

Cc: Clarke, Mary Beth <Marybeth.Clarke@fda.hhs.gov>

Subject: RE: Comms Touch Base: HCQ

Thank you, Jeet.

From: Guram, Jeet <Jeet.Guram@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 11:07 AM

To: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Shah, Anand <Anand.Shah@fda.hhs.gov>; Lenihan, Keagan
<Keagan.Lenihan@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum @fda.hhs.gov>; Caliguiri, Laura
<Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie
<Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne * <Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle
<Dayle.Cristinzio@fda.hhs.gov>; Shreeve, Chris <Christine.Kuethe @fda.hhs.gov>

Cc: Clarke, Mary Beth <Marybeth.Clarke@fda.hhs.gov>

Subject: RE: Comms Touch Base: HCQ

Jeet Guram, M.D.
Senior Advisor, Office of the Commissioner
Food and Drug Administration

+1 (202) 230-0451 | jeet.guram@fda.hhs.gov

From: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>
Sent: Wednesday, June 17, 2020 10:57 AM


<Keagan.Lenihan@fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi
<Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne *

<Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle <Dayle.Cristinzio@fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ

(COC) a)
P|
SS
(ec
LLL | took @ quick stab at

rearranging a bit.

From: Shah, Anand <Anand.Shah@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 10:03 AM

To: Guram, Jeet <Jeet.Guram@fda.hhs.gov>; Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Caliguiri, Laura
<Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie

<Stephanie.Caccomo@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum@fda.hhs.gov>; Pines, Wayne *

<Wayne.Pines@fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ

Great, thanks for the clarification. let’s get feedback from this group and then we can circulate wider

From: Guram, Jeet <Jeet.Guram@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 10:02 AM

To: Shah, Anand <Anand.Shah@fda.hhs.gov>; Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Caliguiri, Laura
<Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie

<Stephanie.Caccomo@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum@fda.hhs.gov>; Pines, Wayne *

<Wayne.Pines@fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ

Thanks — just to clarify this has not been reviewed by CDER yet

Jeet Guram, M.D.

Senior Advisor, Office of the Commissioner
Food and Drug Administration

+1 (202) 230-0451 | jeet.guram@fda.hhs.gov

From: Shah, Anand <Anand.Shah@fda.hhs.gov>
Sent: Wednesday, June 17, 2020 10:01 AM

To: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi
<Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Felberbaum, Michael
<Michael.Felberbaum @fda.hhs.gov>; Pines, Wayne * <Wayne.Pines@fda.hhs.gov>; Guram, Jeet

<Jeet.Guram @fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ

Moving Steve to bcc

Dear All—


INTERNAL FDA USE ONLY

OCET/OCETdocs/nCoV/Shared%20Documents/JIC%20-
%20FDA%20IMG/Internal%20comms/20200611%20-%20JIC%20Clearance%20-
%20COVID%2019%200HS%20Questionnaire%20Revised.docx" ]] and new social distancing
flier for internal use

© InsideFDA: Face Shield Alternative to Face Mask for Medical Concerns [[ HYPERLINK
"http://sharepoint.fda.gov/orgs/OC-OCET/OCETdocs/nCoV/Shared%20Documents/JIC%20-
%20FDA%20IMG/Internal%20comms/20200529%20-
%20Employee%20QA_Face%20Shield%20Alternative%20to%20Face%20Masks%20for%20M
edical%20Concern.docx" ]] - holding for reopening FDA plan

Routine/daily/weekly activities:

e Daily - Prepared talking points for Commissioner Hahn for daily White House Task Force and press
briefing

* Daily - Prepared/posted tweets/graphics on above topics for Commissioner and FDA accounts, and
other social media (e.g., Facebook, LinkedIn)

«Daily or as needed - updated PDFs listing EUAs for [ HYPERLINK
"https://www.fda.gov/media/136832/download" ] and [ HYPERLINK
"https://www.fda.gov/media/136702/download" ]

«  2x/ weekly ({ HYPERLINK “https://www.fda.gov/emergency-preparedness-and-response/about-
mcmi/mcmi-newsletters" ] & Fri): COVID-19 response recap emails to stakeholders

« Weekly (Wed) - [ HYPERLINK "https://www.fda.gov/medical-devices/workshops-conferences-
medical-devices/virtual-town-hall-series-immediately-effect-guidance-coronavirus-covid-19-
diagnostic-tests-04012020" ]

« Weekly (Wed): Coronavirus Q&As for Consumers — top Q&A of week email to Consumer Update
list

e Ongoing internal: additional [ HYPERLINK
"“http://inside.fda.gov:9003/OC/OfficeofScientificMedicalPrograms/OfficeofCounter-
TerrorismandEmergingThreats/COVID-
19%20Information%20for%20FDA%20Staff/ucm646347.htm" \I "_blank" ] for employees for
InsideFDA, and responding to questions received from HHS employee portal

Published yesterday, June 16
« Press statements:

© [HYPERLINK "https://www.fda.gov/news-events/press-announcements/coronavirus-covid-
19-update-daily-roundup-june-16-2020" ] on topics including web FAQ updates on a new
medical device adverse event reporting web page, a serology test EUA revocation, updated
templates for developers that intend their assay to be used for pooling patient samples or
for screening asymptomatic individuals, and a testing update

© [HYPERLINK "https://www.fda.gov/news-events/press-announcements/coronavirus-covid-
19-update-fda-revokes-emergency-use-authorization-chembio-antibody-test" ]

co [HYPERLINK “https://www.fda.gov/news-events/press-announcements/coronavirus-covid-
19-update-facilitating-diagnostic-test-availability-asymptomatic-testing-and" ] (w/CDRH web
updates)

« Emergency Use Authorizations:

© Technical Safety Services LLC; [ HYPERLINK "https://www.fda.gov/media/138954/download"
] (6/13)

© Oceanetics, Inc.; [ HYPERLINK "https://www.fda.gov/media/138955/download" ] (~6/13)

[PAGE \* MERGEFORMAT ]


Sent: Friday, June 12, 2020 4:27 PM

To: Beers, Donald <Donald.Beers@fda.hhs.gov>; Leboeuf, Andrew <Andrew.Leboeuf@fda.hhs.gov>
Ce: Mair, Michael <Michael.Mair@fda.hhs.gov>; Walinsky, Sarah <Sarah.Walinsky@fda.hhs.gov>; Schumann, Katherine
<Katherine.Schumann@fda.hhs.gov>; Sipes, Grail <Grail.Sipes@fda.hhs.gov>; Farley, John <John.Farley@fda.hhs.gov>

Subject: RE: FOUO INFORMATION NOT RELEASABLE UNDER FOIA

Thanks Don- | made a couple of small edits for consistency (B/S) throughout. Thanks.
<< File: Hydroxy revocation db.doc >>

From: Beers, Donald <Donald.Beers@fda.hhs.gov>

Sent: Friday, June 12, 2020 4:08 PM

To: Sadove, Elizabeth <Elizabeth.Sadove@fda.hhs.gov>; Leboeuf, Andrew <Andrew.Leboeuf @fda.hhs.gov>

Cc: Mair, Michael <Michael.Mair@fda.hhs.gov>; Walinsky, Sarah <Sarah.Walinsky@fda.hhs.gov>; Schumann, Katherine
<Katherine.Schumann@fda.hhs.gov>; Sipes, Grail <Grail.Sipes@fda.hhs.gov>; Farley, John <John.Farley@fda.hhs.gov>
Subject: RE: FOUO INFORMATION NOT RELEASABLE UNDER FOIA

Please use this version (revised footnote). Thanks. << File: Hydroxy revocation db.doc >>

From: Beers, Donald

Sent: Friday, June 12, 2020 4:04 PM

To: Sadove, Elizabeth <Elizabeth.Sadove@fda.hhs.gov>; Leboeuf, Andrew <Andrew.Leboeuf @fda.hhs.gov>

Cc: Mair, Michael <Michael.Mair@fda.hhs.gov>; Walinsky, Sarah <Sarah.Walinsky@fda.hhs.gov>; Schumann, Katherine
<Katherine.Schumann@fda.hhs.gov>; Sipes, Grail <Grail.Sipes@fda.hhs.gov>; Farley, John <John.Farley@fda.hhs.gov>
Subject: RE: FOUO INFORMATION NOT RELEASABLE UNDER FOIA

Liz,
Thanks for putting this together. In the attached | have suggested some edits. Let me know what you think.

Don << File: Hydroxy revocation db.doc >>

From: Sadove, Elizabeth <Elizabeth.Sadove@fda.hhs.gov>

Sent: Friday, June 12, 2020 12:07 PM

To: Beers, Donald <Donald.Beers@fda.hhs.gov>; Leboeuf, Andrew <Andrew.Leboeuf@fda.hhs.gov>

Ce: Mair, Michael <Michael.Mair@fda.hhs.gov>; Walinsky, Sarah <Sarah.Walinsky@fda.hhs.gov>; Schumann, Katherine

<Katherine.Schumann@fda.hhs.gov>
Subject: RE: FOUO INFORMATION NOT RELEASABLE UNDER FOIA

Attached isa sil craft. (E)() lll
Cd
a
Thanks.

<< File: Hydroxy revocation.doc >>

From: Beers, Donald <Donald.Beers@fda.hhs.gov>


INTERNAL FDA USE ONLY

Ow
e =ORA:

© Guidance: Disinfection of Surfaces on Interstate Conveyances (OMA clearance)
e  OPLIA:

© Feature to go in ORAcle on ORA employee's experience being in India during pandemic and
visiting hydroxychloroquine plant [internal to ORA + external comms TBD]

© CTP:

°

e Consumer & patient updates:

© Language translation of FAQs on face coverings and for DIY ventilator makers

© Getting Smarter About Food Safety: The Pandemic and Lessons Learned (based on similar
FDA Voices)

e Web updates:

© OC/CDRH: User-friendly tool on website for labs that need information on test component
substitutes when supply issues arise (+ webinar)

©  OCET: New page: Updates on activities performed under the rapid response to COVID-19 3D
printing [ HYPERLINK "https://www.fda.gov/emergency-preparedness-and-
response/coronavirus-disease-2019-covid-19/fda-efforts-connect-manufacturers-and-
health-care-entities-fda-department-veterans-affairs-national" ] (w/NIH, VA) [[ HYPERLINK
"“http://sharepoint.fda.gov/orgs/OC-OCET/OCETdocs/nCoV/Shared%20Documents/JIC%20-
%20FDA%20IMG/CDRH/20200522_3DprintWMOU_update.docx" ]] ~maybe week of 6/8

e Stakeholders:

o Pharmaceutical Care Management Association (PCMA) [ HYPERLINK
“https://www.pcmanet.org/pcma-event/pcma-spring-webinar-series-2020/" ] (Drs. Shah
and Guram) 6/11 - TPs forthcoming for JIC/OCC clearance (POC: Chaitali Patel)

© C-PATH press release: C-Path Launches CURE Drug Repurposing Collaboratory to Accelerate
Identification of Existing Drugs to Treat Infectious Diseases, Including COVID-19 (FDA-funded
work, including an FDA quote) - week of 6/8? [[ HYPERLINK
"http://sharepoint.fda.gov/orgs/OC-OCET/OCETdocs/nCoV/Shared%20Documents/JIC%20-
%20FDA%20IMG/Press/For%20clearance/CURE_PPP-Draft_PressRelease-
6%208%2020.docx" ]]

© CDER: Virtual/remote human factor validation testing follow-up (internal reactive Q&A)

© OEA: Stakeholder toolkit for Convalescent Plasma, including fact sheet, tweets, and
newsletter content (some materials in toolkit now available in Spanish) - likely week of 6/8

© Drug Information Association (DIA) 2020 Virtual Global Annual Meeting: Regulatory Agility
Under COVID 19 -Jeannie David (DSS) — 6/16

© SES: Dr. Hahn to provide opening remarks on call with American Hospital Association
(membership meeting about 700 members) - planning phase - 6/18

© MedDRA User's Group webinar: Impact of COVID-19 on pharmacovigilance, Sonja Brajovic
(OSE) - 6/18

© ~RADM Araojo presenting (via pre-recorded video) on Under-representation in Clinical Trials
and the Implications for Drug Development, [ HYPERLINK
“https://www.aacr.org/meeting/aacr-annual-meeting-2020/aacr-virtual-annual-meeting-ii/"
], including highlighting FDA OMHHE’s ongoing efforts in response to COVID-19 [[ HYPERLINK
“http://sharepoint.fda.gov/orgs/OC-OCET/OCETdocs/nCoV/Shared%20Documents/JIC%20-
%20FDA%20IMG/Stakeholders/For%20clearance/20200622_AACRPanel%20.docx" ] - talking
points] 6/22

e Internal:

[PAGE \* MERGEFORMAT ]


From: Sadove, Elizabeth [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=FD45C627000D4F34B9DB362FF2B6AF4B-SADOVEE]
Sent: 6/12/2020 6:51:57 PM

To: Hinton, Denise [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=85feca0be0694803be6030e9 7c7 b4adb-HINTOND]

Subject: RE: FOUO INFORMATION NOT RELEASABLE UNDER FOIA

Thanks

From: Hinton, Denise <Denise.Hinton@fda.hhs.gov>

Date: June 12, 2020 at 6:40:39 PM EDT

To: Sadove, Elizabeth <Elizabeth.Sadove@fda.hhs.gov>

Subject: RE: FOUO INFORMATION NOT RELEASABLE UNDER FOIA

‘Thhark yu, Liz. ()/(5) lt

Best,
Denise

From: Sadove, Elizabeth <Elizabeth.Sadove@fda.hhs.gov>

Sent: Friday, June 12, 2020 6:29 PM

To: Hinton, Denise <Denise.Hinton@fda.hhs.gov>

Subject: FW: FOUO INFORMATION NOT RELEASABLE UNDER FOIA

This is the revocation letter for the hydroxy/chloroquine EUA. (6))6)
ee

From: Beers, Donald <Donald.Beers@fda.hhs.gov>

Sent: Friday, June 12, 2020 5:46 PM

To: Sadove, Elizabeth <Elizabeth.Sadove@fda.hhs.gov>; Leboeuf, Andrew <Andrew.Leboeuf@fda.hhs.gov>
Cc: Mair, Michael <Michael.Mair@fda.hhs.gov>; Sipes, Grail <Grail.Sipes@fda.hhs.gov>; Farley, John
<John.Farley@fda.hhs.gov>

Subject: RE: FOUO INFORMATION NOT RELEASABLE UNDER FOIA

Thanks, Liz. For anyone who has not yet viewed this, | have added my revision to the footnote to the version Liz
provided in the attached. (If you have already marked up the previous version, you can send me that.)

Please let me know if you have any comments or if you will not have comments, | guess at least by tomorrow
morning. Liz and Andrew, who else will need to review this before it is finalized for signature on Monday?

Andrew, do you have a sense of when you might have the memo to be enclosed ready for review?

Don << File: Hydroxy revocation db 4 40.doc >>

From: Sadove, Elizabeth <Elizabeth.Sadove@fda.hhs.gov>


° Q: What is the FDA’s role in regulating animal drugs, animal food (including pet food), and
animal medical devices?

. Stakeholders:

° CDRH: Webinar Series - Respirators for Health Care Personnel Use during COVID-19 Pandemic - first
event in series + email including save-the-date for next webinar on 6/23

° CDER: Hand sanitizer internal reactive QA [SP link]

° CDER: Division of Drug Information CURE 1D webinar for HCPs - Capturing Clinician’s Experiences

Repurposing Drugs to Inform Future Studies in the Era of COVID-1 — Speaker Heather Stone (OMP) + web page update
(outreach/SM pending)

° CFSAN/OFPR - FDA call with produce industry to discuss CDC guidance on farm workers and employers
and recent FDA guidances relevant to that industry. CDC and OSHA also participated in the call.

SITREP ENDS

MEETING REPORT OUT (see Op Tempo for dial-in #s)

. Standing meetings updates (task forces, etc.)

. Hearings/Hill briefings

. NICCL calls (Tu/Th 10:15 a.m.)

MEDIA MONITORING

. See daily a.m. JIC email from Andrea Takash

. See NICCL JIC folder for social listening and other reports
HH

April Finnen

IMG JIC Section Chief

2019 Novel Coronavirus (COVID-19) Incident Management Group (IMG)
U.S. Food and Drug Administration

Cell: 240-507-7742 €Call this # or IM/Skype to reach me

Email: ¢
JIC &

U.S. FOOD & DRUG

ads email: 2019-nCoV-FDA-IMG-JIC-Leadership@fda.hhs.gov

ADMINISTRATION

BOoO- 8


Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Shah, Anand <Anand.Shah@fda.hhs.gov>; Felberbaum, Michael
<Michael.Felberbaum @fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi
<Heidi.Rebello@ fda.hhs.
<Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle <Dayle.Cristinzio@fda.hhs.gov>; Guram, Jeet <Jeet.Guram@fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ.

Thank you, Don. We will get it through CDER as quickly as possible and then back to you.

Chris

From: Beers, Donald <Donald.Beers@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 4:42 PM

To: Shreeve, Chris <Christine.Kuethe@fda.hhs.gov>; Guram, Jeet <Jeet.Guram @fda.hhs.gov>

Cc: Clarke, Mary Beth <Marybeth.Clarke@fda.hhs.gov>; Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Cavazzoni,
Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Shah, Anand <Anand.Shah@fda.hhs.gov>; Felberbaum, Michael
<Michael.Felberbaum@fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi
<Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne *
<Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle <Dayle.Cristinzio@fda.hhs.gov>

Subject: RE: Comms Touch Base: HCQ.

Chris,

lam glad to give my feedback now, but it would probably be good for me to look again if there are further revisions. |
have a couple of comments with potential edits on the last page of the attached.

Don

From: Shreeve, Chris <Christine.Kuethe@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 3:22 PM

To: Guram, Jeet <Jeet.Guram@fda.hhs.gov>

Cc: Clarke, Mary Beth <Marybeth.Clarke@fda.hhs.gov>; Beers, Donald <Donald.Beers@fda.hhs.gov>; Lenihan, Keagan
<Keagan.Lenihan@fda.hhs.gov>; Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Shah, Anand
<Anand.Shah@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum @fda.hhs.gov>; Caliguiri, Laura
<Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie
<Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne * <Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle
<Dayle.Cristinzio@fda.hhs.gov>

Subject: RE: Comms Touch Base: HCQ.

Hi,
Just checking. Has this gone through CDER or will it go there after Don clears? Thanks!

Chris

Chris Shreeve
Director, Office of Communications

Center for Drug Evaluation and Research
U.S. Food and Drug Administration
Tel: 240-402-5772

chris.shreeve@fda.hhs.gov


From: Finnen, April [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=43D74B830BB1D429184B0D908 1EFE19BF-APRIL.FINNE]

Sent: 6/17/2020 7:49:09 AM

To: 2019-nCoV FDA IMG JIC [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=289715a1146847558b07a33ccab6bccf-2019-nCoV F}

cc: Mair, Michael [/o=ExchangeLabs/ou=Exchange Administrative Group

(FYDIBOHF23SPDLT)/cn=Recipients/cn=f4511bdad7564d7fac7eadc7961467ab-Michael.Mai]; Hinton, Denise
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=85feca0be0694803be6030e97c7 b4adb-HINTOND]

Subject: 10:00 JIC notes

Attachments: 20200617_JICMeetingNotes.docx

JIC daily check-in M-F, 10:00 — 10:30 a.m. WebEx only. For first part of meeting, we will run down status of current
items, then focus on hot topics, if any. After the meeting, updated notes will be available in SharePoint (JIC meeting

notes folder).

Reminders/notes/resources:

. Please ask, "Who else needs to know?" (remember to use JIC email lists, in case people are on leave - "Which
email do | use?" is included in the Welcome to JIC file)

° Major study finds common steroid reduces deaths among patients with severe Covid-19 (STAT, referring to
dexamethasone)

TODAY’S FOCUS DISCUSSION (Second half of meeting)
. Hot topics for the group
. From NICCL call - HHS will issue a press release on distribution of remdesivir Saturday morning

Pending, from previous discussions:
. ACTION: teams will review their evergreen content, including evergreen tweets, for continued
relevance/appropriateness of use, and we'll discuss w/new ideas on Thursday June 18

Press/Media Engagements:
. What is Dr. Hahn up to today
. White House (TPs, when needed: Michael F.)

Then, by area:

Press releases/media/WHTF
CDRH

CDER

CBER

CFSAN

CVM

ORA

OPLIA

CTP

occ

OL

Consumer
Stakeholder

Web

Social

Internal

Meeting report-outs

Ce


From: Mair, Michael [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=F4511BDAD7564D7FAC7EADC7961467AB-MICHAEL.MAI]

Sent: 6/8/2020 12:57:22 PM
To: Hinton, Denise [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=85 feca0be0694803be6030e97c7 b4adb-HINTOND]

Subject: does the Commish know

About the HCQ/CQ EUA revocation?


From: Beers, Donald <Donald.Beers@fda.hhs.gov>
Sent: Friday, June 12, 2020 4:08 PM

To: Sadove, Elizabeth <Elizabeth.Sadove@fda.hhs.gov>; Leboeuf, Andrew <Andrew.Leboeuf@fda.hhs.gov>

Cc: Mair, Michael <Michael.Mair@fda.hhs.gov>; Walinsky, Sarah <Sarah.Walinsky@fda.hhs.gov>; Schumann, Katherine
<Katherine.Schumann@fda.hhs.gov>; Sipes, Grail <Grail.Sipes@fda.hhs.gov>; Farley, John <John.Farley@fda.hhs.gov>
Subject: RE: FOUO INFORMATION NOT RELEASABLE UNDER FOIA

Please use this version (revised footnote). Thanks. << File: Hydroxy revocation db.doc >>

From: Beers, Donald

Sent: Friday, June 12, 2020 4:04 PM

To: Sadove, Elizabeth <Elizabeth.Sadove @fda.hhs.gov>; Leboeuf, Andrew <Andrew.Leboeuf@fda.hhs.gov>

Ce: Mair, Michael <Michael.Mair@fda.hhs.gov>; Walinsky, Sarah <Sarah.Walinsky@fda.hhs.gov>; Schumann, Katherine
<Katherine.Schumann@fda.hhs.gov>; Sipes, Grail <Grail.Sipes@fda.hhs.gov>; Farley, John <John.Farley@fda.hhs.gov>
Subject: RE: FOUO INFORMATION NOT RELEASABLE UNDER FOIA

Liz,
Thanks for putting this together. In the attached | have suggested some edits. Let me know what you think.

Don << File: Hydroxy revocation db.doc >>

From: Sadove, Elizabeth <Elizabeth.Sadove@fda.hhs.gov>

Sent: Friday, June 12, 2020 12:07 PM

To: Beers, Donald <Donald.Beers@fda.hhs.gov>; Leboeuf, Andrew <Andrew.Leboeuf@fda.hhs.gov>

Cc: Mair, Michael <Michael.Mair@fda.hhs.gov>; Walinsky, Sarah <Sarah.Walinsky@fda.hhs.gov>; Schumann, Katherine
<Katherine.Schumann@fda.hhs.gov>

Subject: RE: FOUO INFORMATION NOT RELEASABLE UNDER FOIA

Attached isa sirple craft. (ICS) lle
id
|
[TT Trans.

<< File: Hydroxy revocation.doc >>

From: Beers, Donald <Donald.Beers@fda.hhs.gov>
Sent: Friday, June 12, 2020 11:51 AM
To: Leboeuf, Andrew <Andrew.Leboeuf@fda.hhs.gov>

Cc: Mair, Michael <Michael.Mair@fda.hhs.gov>; Sadove, Elizabeth <Elizabeth.Sadove @fda.hhs.gov>; Walinsky, Sarah
<Sarah.Walinsky@fda.hhs.gov>; Schumann, Katherine <Katherine.Schumann@fda.hhs.gov>
Subject: FW: FOUO INFORMATION NOT RELEASABLE UNDER FOIA

FYI
<< File: BARDA EUA 039 Withdrawal Letter FINAL.docx >>


Shreeve, Chris <Christine.Kuethe@fda.hhs.gov>; Hunt, Alison <Alison.Hunt@fda.hhs.gov>; Tantillo, Andrew
<Andrew.Tantillo@fda.hhs.gov>; Gross, Karas <Karas.Gross@fda.hhs.gov>; McBride, Maren
<Maren.McBride@fda.hhs.gov>; Anderson, Erika <Erika.Anderson@fda.hhs.gov>; Finnen, April
<April.Finnen@fda.hhs.gov>; Cristinzio, Dayle <Dayle.Cristinzio@fda.hhs.gov>; Walsh, Sandy

<Sandy.Walsh @fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi
<Heidi.Rebello@fda.hhs.gov>; Lynch, Sarah <Sarah.Lynch@fda.hhs.gov>; Black, Jennifer Jennifer.Black@fda.hhs.gov>;
Meister, Karen G <Karen.Meister @fda.hhs.gov>; Alexander, Nicholas <Nicholas.Alexander@fda.hhs.gov>; Sykes,
LaShawn <LaShawn.Sykes@fda.hhs.gov>; Kimberly, Brad <Brad.Kimberly@fda.hhs.gov>; Schipper, Jodi
<jodi.schipper@fda.hhs.gov>; Morin, Steve <Steve.Morin@fda.hhs.gov>; Cooper, Mildred
<Mildred.Cooper@fda.hhs.gov>; Wohl, Alexander <Alexander.Wohl@fda.hhs.gov>; Mair, Michael
<Michael.Mair@fda.hhs.gov>; Sadove, Elizabeth <Elizabeth.Sadove@fda.hhs.gov>; Guevara, Bessy
<Bessy.Guevara@fda.hhs.gov>; Klimczak, Katherine <Katherine.Klimczak@fda.hhs.gov>; Van Pool, Kendall
<Kendall.VanPool@fda.hhs.gov>; Leggin, Brooke <Brooke.Leggin@fda.hhs.gov>; ODonnell, Allison
<Allison.ODonnell@fda.hhs.gov>; Pines, Wayne * <Wayne.Pines@fda.hhs.gov>; Elicker, Janet
<Janet.Elicker@fda.hhs.gov>; Roberts, Michelle <Michelle.Roberts1@fda.hhs.gov>; Luebke, Yasemin
<Yasemin.Luebke@fda.hhs.gov>; Hodnette, Jonathan <Jonathan.Hodnette@fda.hhs.gov>; Campbell, Christopher
<Christopher.Campbell@fda.hhs.gov>; Leboeuf, Andrew <Andrew.Leboeuf@fda.hhs.gov>; Schumann, Katherine
<Katherine.Schumann@fda.hhs.gov>; Walinsky, Sarah <Sarah.Walinsky@fda.hhs.gov>; Kraus, Stefanie
<Stefanie.Kraus@fda.hhs.gov>; Beers, Donald <Donald.Beers@fda.hhs.gov>; Raza, Mark <Mark.Raza@fda.hhs.gov>;
Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Abram, Anna <Anna.Abram@fda.hhs.gov>; Shah, Anand
<Anand.Shah@fda.hhs.gov>

Cc: Sipes, Grail <Grail.Sipes@fda.hhs.gov>; Farley, John <John.Farley@fda.hhs.gov>

Subject: Rollout Email for HCQ

Hi all—
Just flagging the rollout email so we are all in awareness. Please send all updates to this. April/Jan/Kristen—please send
weblinks here so we can all see.

Thanks!!

Stephanie Caccomo
Press Officer

Office of Media Affairs

Office of External Affairs

U.S, Food and Drug Administration
Desk: 301.348.1956

Cell: (5)
stephanie.caccomo@fda.hhs.gov

From: Caccomo, Stephanie

Sent: Sunday, June 14, 2020 8:31 PM

To: Booze, Kristen <Kristen.Booze@fda.hhs.gov>; Baumgartner, Kristofer (Kristofer.Baumgartner @fda.hhs.gov)
<Kristofer.Baumgartner@fda.hhs.gov>; Shreeve, Chris <Christine.Kuethe@fda.hhs.gov>; Hunt, Alison

<Alison.Hunt @fda.hhs.gov>; Tantillo, Andrew <Andrew. Tantillo@fda.hhs.gov>; Gross, Karas
<Karas.Gross@fda.hhs.gov>; McBride, Maren <Maren.McBride@ fda.hhs.gov>; Anderson, Erika
<Erika.Anderson@fda.hhs.gov>; Finnen, April <April.Finnen@fda.hhs.gov>; Cristinzio, Dayle
<Dayle.Cristinzio@fda.hhs.gov>; Walsh, Sandy <Sandy.Walsh@fda.hhs.gov>; Caliguiri, Laura
<Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>; Lynch, Sarah <Sarah.Lynch@fda.hhs.gov>;
Black, Jennifer <Jennifer.Black@fda.hhs.gov>; Meister, Karen G <Karen.Meister@fda.hhs.gov>; Alexander, Nicholas
<Nicholas.Alexander @fda.hhs.gov>; Sykes, LaShawn <LaShawn.Sykes@fda.hhs.gov>; Kimberly, Brad
<Brad.Kimberly@fda.hhs.gov>; Schipper, Jodi <jodi.schipper@fda.hhs.gov>; Morin, Steve <Steve.Morin@fda.hhs.gov>;
Cooper, Mildred <Mildred.Cooper@fda.hhs.gov>; Wohl, Alexander <Alexander.Woh|@fda.hhs.gov>; Mair, Michael
(Michael.Mair@fda.hhs.gov) <Michael.Mair @fda.hhs.gov>; Sadove, Elizabeth (Elizabeth.Sadove@fda.hhs.gov
<Elizabeth.Sadove @fda.hhs.gov>; Guevara, Bessy <Bessy.Guevara@fda.hhs.gov>; Klimczak, Katherine



From: Kadakia, Kushal [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=A10A749D49F9473AA2CD046423EE61BD-KUSHAL.KADA]

Sent: 6/28/2020 9:24:35 PM

To: Shah, Anand [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=e2172ebbd96946c08e189fd612855f51-Anand.Shah])

Subject: RE: Review requested of remarks for Dr. Shah on chloroquine and Hydroxychloroquine -- BY 6 pm today

Yes will do

From: Shah, Anand <Anand.Shah@fda.hhs.gov>

Sent: Sunday, June 28, 2020 11:09 AM

To: Kadakia, Kushal <Kushal.Kadakia@fda.hhs.gov>

Subject: FW: Review requested of remarks for Dr. Shah on chloroquine and Hydroxychloroquine -- BY 6 pm today

(b) (5)

From: Shah, Anand

Sent: Thursday, June 25, 2020 10:19 AM

To: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>
Cc: Cristinzio, Dayle <Dayle.Cristinzio@fda.hhs.gov>

Subject: RE: Review requested of remarks for Dr. Shah on chloroquine and Hydroxychloroquine -- BY 6 pm today

Thanks Patrizia. +Dayle here for logistical details on the event
Anand

From: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>

Sent: Wednesday, June 24, 2020 5:56 PM

To: Shah, Anand <Anand.Shah@fda.hhs.gov>; Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>

Subject: RE: Review requested of remarks for Dr. Shah on chloroquine and Hydroxychloroquine -- BY 6 pm today

Thank you. | just cleared the TPs for CDER. | will look at the final version when ready (B)(S)

Patrizia

From: Shah, Anand <Anand.Shah@fda.hhs.gov>

Sent: Wednesday, June 24, 2020 5:30 PM

To: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>

Cc: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>

Subject: Re: Review requested of remarks for Dr. Shah on chloroquine and Hydroxychloroquine -- BY 6 pm today

Let me check on the date - will come back to you - this was set up by OEA. (b) (6)

On Jun 24, 2020, at 17:01, Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov> wrote:

When is this planned for and will you need anyone from CDER to participate?
Patrizia


MEETING REPORT OUT (see Op Tempo for dial-in #s)

. Standing meetings updates (task forces, etc.)

. Hearings/Hill briefings

. NICCL calls (Tu/Th 10:15 a.m.)

MEDIA MONITORING

. See daily a.m. JIC email from Andrea Takash

. See NICCL JIC folder for social listening and other reports
HHH

April Finnen

IMG JIC Section Chief

2019 Novel Coronavirus (COVID-19) Incident Management Group (IMG)
U.S. Food and Drug Administration

Cell: 240-507-7742 €Call this # or IM/Skype to reach me

Email: april finnen@fda.hhs.gov
JIC (Joint Information Center) leads email:

U.S. FOOD & DRUG

ADMINISTRATION

ooO- &



Sent: 6/12/2020 6:34:13 PM

To: Sadove, Elizabeth [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=fd45c627000d4f34b9db362ff2b6af4b-SADOVEE]
Subject: RE: FOUO INFORMATION NOT RELEASABLE UNDER FOIA

Thank you for sending in advance for review. | will see if Anand needs to review.

From: Sadove, Elizabeth <Elizabeth.Sadove@fda.hhs.gov>

Sent: Friday, June 12, 2020 6:29 PM

To: Hinton, Denise <Denise.Hinton@fda.hhs.gov>

Subject: FW: FOUO INFORMATION NOT RELEASABLE UNDER FOIA

This is the revocation letter for the hydroxy/chloroquine EUA. _ It’s readying for clearance, with the goal of signing
Monday morning. Does anyone else in OC (e.g., Anand, Anna) need to review?

From: Beers, Donald <Donald.Beers@fda.hhs.gov>

Sent: Friday, June 12, 2020 5:46 PM

To: Sadove, Elizabeth <Elizabeth.Sadove @fda.hhs.gov>; Leboeuf, Andrew <Andrew.Leboeuf@fda.hhs.gov>
Cc: Mair, Michael <Michael.Mair@fda.hhs.gov>; Sipes, Grail <Grail.Sipes@fda.hhs.gov>; Farley, John
<John.Farley@fda.hhs.gov>

Subject: RE: FOUO INFORMATION NOT RELEASABLE UNDER FOIA

Thanks, Liz. For anyone who has not yet viewed this, | have added my revision to the footnote to the version Liz
provided in the attached. (If you have already marked up the previous version, you can send me that.)

Please let me know if you have any comments or if you will not have comments, | guess at least by tomorrow morning.
Liz and Andrew, who else will need to review this before it is finalized for signature on Monday?

Andrew, do you have a sense of when you might have the memo to be enclosed ready for review?

Don << File: Hydroxy revocation db 4 40.doc >>

From: Sadove, Elizabeth <Elizabeth.Sadove@fda.hhs.gov>

Sent: Friday, June 12, 2020 4:27 PM

To: Beers, Donald <Donald.Beers@fda.hhs.gov>; Leboeuf, Andrew <Andrew.Leboeuf@fda.hhs.gov>

Cc: Mair, Michael <Michael.Mair@fda.hhs.gov>; Walinsky, Sarah <Sarah.Walinsky@fda.hhs.gov>; Schumann, Katherine
<Katherine.Schumann@fda.hhs.gov>; Sipes, Grail <Grail.Sipes@fda.hhs.gov>; Farley, John <John.Farley@fda.hhs.gov>
Subject: RE: FOUO INFORMATION NOT RELEASABLE UNDER FOIA

Thanks Don- | made a couple of small edits for consistency (6)(5)) throughout. Thanks.
<< File: Hydroxy revocation db.doc >>

From: Beers, Donald <Donald.Beers@fda.hhs.gov>
Sent: Friday, June 12, 2020 4:08 PM


e =CDER:
°

°

e =CBER:
°
°
°

°

INTERNAL FDA USE ONLY

= Recalls of Medical Devices and Corrective Actions/Repairs of Electronic Products
During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency —
week of 6/22 or later

= Effects of the COVID-19 Public Health Emergency on Formal Meetings and User
Fee Applications — week of 6/22 or later

= Enforcement Policy for Non-invasive Electrical Stimulation Devices Intended for
Treatment of Major Depressive Disorder (MDD) — week of 6/22 or later

= Enforcement Policy for Digital Health and Stimulation Therapeutic Devices for
Physical Rehabilitation — week of 7/5 or later

= Enforcement Policy for Coagulation Systems for Measurement of Viscoelastic
Properties During the Coronavirus Disease 2019 (COVID-19) Public Health
Emergency — timing TBD

= Becton, Dickinson and Company, Veritor SARS-CoV-2 Assay

= Spectrum Solutions LLC, SDNA-1000 Saliva Collection Device

= Fulgent/Picture Genetics; Nasal swab home collection kit - timing TBD

= Rapid Rona home collection kit using Hologic's Panther Fusion COVID-19 EUA
assay - timing TBD

= Additions to umbrella EUAs for various devices, ventilators, and support
accessories

Stakeholders:

CDER guidance: Statistical Considerations for Clinical Trials During the COVID-19 Public
Health Emergency (+Daily Roundup, listserv messages [[ HYPERLINK
"http://sharepoint.fda.gov/orgs/OC-
OCET/OCETdocs/nCoV/Shared%20Documents/JIC%20-
%20FDA%20IMG/CDER/StatsCovid19GuidanceDraftEmailsJune15.docx" ]]) - likely
week of 6/15, later in week (in OMB clearance)

Beyond this week:

Guidance: COVID-19 infection in Employees in Pharmaceutical Manufacturing (+Daily
Roundup, listserv, reactive QAs) — late June

Guidance: Manufacturing, Supply Chain, and Drug Inspections During COVID-19 Public
Health Emergency - Questions and Answers (+Daily Roundup) — late June

Health Affairs Blog: CDER’s Contributions Towards Protecting Public Health During the
COVID-19 Pandemic By Patrizia Cavazzoni, M.D. [[ HYPERLINK
"http://sharepoint.fda.gov/orgs/OC-
OCET/OCETdocs/nCoV/Shared%20Documents/JIC%20-
%20FDA%20IMG/CDER/HACDERWorkCovid19PandemicJune4.docx" ]] - June/July

Use of stem cells (comms and target date TBD)

Updates on HCT/Ps - late week of 6/15, or week of 6/22
Guidance on vaccines - timing TBD

e = CFSAN:
Checklist (w/CVM): Employee Health and Food Safety Checklist for Human and Animal Food
Operations During COVID-19 [[ HYPERLINK
"http://sharepoint.fda.gov/orgs/OFVM/OFVM%20landing%20page/Cross_Cutting_Issues/Sh
ared%20Documents/FSMA%202019-2020/FSMA%20and%20COVID-
19/Employee%20Health%20Food%20Safety%20-Checklist-for-reopening-and-operation-

[PAGE \* MERGEFORMAT ]


Dear All-

Following up from yesterday’s discussion, Jeet worked with CDER on a proposed statement that provides scientific
rationale for our decision.

We welcome your feedback.
Thank you

Anand

-----Original Appointment-----

From: Hahn, Stephen <SH1@fda.hhs.gov>

Sent: Monday, June 15, 2020 9:44 PM

To: Hahn, Stephen; Lenihan, Keagan; Shah, Anand; Caliguiri, Laura; Rebello, Heidi; Caccomo, Stephanie; Felberbaum,
Michael; Pines, Wayne *

Subject: Comms Touch Base: HCQ

When: Tuesday, June 16, 2020 8:15 AM-8:30 AM (UTC-05:00) Eastern Time (US & Canada).

Where: (6)(6)


<Wayne.Pines@fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ

Thanks — just to clarify this has not been reviewed by CDER yet

Jeet Guram, M.D.
Senior Advisor, Office of the Commissioner
Food and Drug Administration

+1 (202) 230-0451 | jeet.guram@fda.hhs.gov

From: Shah, Anand <Anand.Shah@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 10:01 AM

To: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi
<Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Felberbaum, Michael
<Michael.Felberbaum @fda.hhs.gov>; Pines, Wayne * <Wayne.Pines@fda.hhs.gov>; Guram, Jeet

<Jeet.Guram @fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ

Moving Steve to bcc
Dear All—

Following up from yesterday’s discussion, Jeet worked with CDER on a proposed statement that provides scientific
rationale for our decision.

We welcome your feedback.
Thank you

Anand

a= Original Appointment-----

From: Hahn, Stephen <SH1@fda.hhs.gov>

Sent: Monday, June 15, 2020 9:44 PM

To: Hahn, Stephen; Lenihan, Keagan; Shah, Anand; Caliguiri, Laura; Rebello, Heidi; Caccomo, Stephanie; Felberbaum,
Michael; Pines, Wayne *

Subject: Comms Touch Base: HCQ.

When: Tuesday, June 16, 2020 8:15 AM-8:30 AM (UTC-05:00) Eastern Time (US & Canada).

Where: (6) (6) lll


To: Sadove, Elizabeth <Elizabeth.Sadove@fda.hhs.gov>; Leboeuf, Andrew <Andrew.Leboeuf @fda.hhs.gov>

Ce: Mair, Michael <Michael.Mair@fda.hhs.gov>; Walinsky, Sarah <Sarah.Walinsky@fda.hhs.gov>; Schumann, Katherine
<Katherine.Schumann@fda.hhs.gov>; Sipes, Grail <Grail.Sipes@fda.hhs.gov>; Farley, John <John.Farley@fda.hhs.gov>
Subject: RE: FOUO INFORMATION NOT RELEASABLE UNDER FOIA

Please use this version (revised footnote). Thanks. << File: Hydroxy revocation db.doc >>

From: Beers, Donald

Sent: Friday, June 12, 2020 4:04 PM

To: Sadove, Elizabeth <Elizabeth.Sadove@fda.hhs.gov>; Leboeuf, Andrew <Andrew.Leboeuf@fda.hhs.gov>

Cc: Mair, Michael <Michael.Mair@fda.hhs.gov>; Walinsky, Sarah <Sarah.Walinsky@fda.hhs.gov>; Schumann, Katherine
<Katherine.Schumann@fda.hhs.gov>; Sipes, Grail <Grail.Sipes@fda.hhs.gov>; Farley, John <John.Farley@fda.hhs.gov>
Subject: RE: FOUO INFORMATION NOT RELEASABLE UNDER FOIA

Liz,
Thanks for putting this together. In the attached | have suggested some edits. Let me know what you think.

Don << File: Hydroxy revocation db.doc >>

From: Sadove, Elizabeth <Elizabeth.Sadove@fda.hhs.gov>

Sent: Friday, June 12, 2020 12:07 PM

To: Beers, Donald <Donald.Beers@fda.hhs.gov>; Leboeuf, Andrew <Andrew.Leboeuf@fda.hhs.gov>

Ce: Mair, Michael <Michael.Mair@fda.hhs.gov>; Walinsky, Sarah <Sarah.Walinsky@fda.hhs.gov>; Schumann, Katherine
<Katherine.Schumann@fda.hhs.gov>

Subject: RE: FOUO INFORMATION NOT RELEASABLE UNDER FOIA

Attached is a sirmple craft. — (6/5) lll
_TC~*d
[ETTEETE- Thanks,

<< File: Hydroxy revocation.doc >>

From: Beers, Donald <Donald.Beers@fda.hhs.gov>

Sent: Friday, June 12, 2020 11:51 AM

To: Leboeuf, Andrew <Andrew.Leboeuf @fda.hhs.gov>

Cc: Mair, Michael <Michael.Mair@fda.hhs.gov>; Sadove, Elizabeth <Elizabeth.Sadove@fda.hhs.gov>; Walinsky, Sarah
<Sarah.Walinsky@fda.hhs.gov>; Schumann, Katherine <Katherine.Schumann@fda.hhs.gov>

Subject: FW: FOUO INFORMATION NOT RELEASABLE UNDER FOIA

FYI
<< File: BARDA EUA 039 Withdrawal Letter FINAL.docx >>

From: Beers, Donald
Sent: Friday, June 12, 2020 11:44 AM
To: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Farley, John <John.Farley@fda.hhs.gov>; Sipes, Grail


From: Felberbaum, Michael <Michael.Felberbaum@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 10:21 AM

To: Shah, Anand <Anand.Shah@fda.hhs.gov>; Guram, Jeet <Jeet.Guram @fda.hhs.gov>; Lenihan, Keagan
<Keagan.Lenihan@fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi
<Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne *
<Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle <Dayle.Cristinzio@fda.hhs.gov>

Subject: RE: Comms Touch Base: HCQ

From: Shah, Anand <Anand.Shah@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 10:03 AM

To: Guram, Jeet <Jeet.Guram @fda.hhs.gov>; Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Caliguiri, Laura
<Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie

<Stephanie.Caccomo@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum@fda.hhs.gov>; Pines, Wayne *

<Wayne.Pines@fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ

Great, thanks for the clarification. let’s get feedback from this group and then we can circulate wider

From: Guram, Jeet <Jeet.Guram@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 10:02 AM

To: Shah, Anand <Anand.Shah@fda.hhs.gov>; Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Caliguiri, Laura
<Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie
<Stephanie.Caccomo@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum @fda.hhs.gov>; Pines, Wayne *

<Wayne.Pines@fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ

Thanks — just to clarify this has not been reviewed by CDER yet

Jeet Guram, M.D.
Senior Advisor, Office of the Commissioner
Food and Drug Administration

+1 (202) 230-0451 | jeet.guram@fda.hhs.gov

From: Shah, Anand <Anand.Shah@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 10:01 AM

To: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi
<Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie <Stephanie.Caccomo @fda.hhs.gov>; Felberbaum, Michael
<Michael.Felberbaum @fda.hhs.gov>; Pines, Wayne * <Wayne.Pines@fda.hhs.gov>; Guram, Jeet

<Jeet.Guram @fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ

Moving Steve to bec


From: Amin, Stacy [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=CB3764B7438648838C22881A06FC6AFB-STACY.AMIN]

Sent: 6/16/2020 4:01:59 PM

To: Lenihan, Keagan [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=ee7320ee8c184d66bfd521b0105d17d2-Keagan.Leni]; Felberbaum, Michael
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=4819a643ca2945cdb1a2631b83e69673-Michael.Fel]

ce: Shah, Anand [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=e2172ebbd96946c08e189fd612855f51-Anand. Shah]; Caliguiri, Laura
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=aa086f2d6c0346c49e996932d86ac62e-Laura.Calig]; Rebello, Heidi
{/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=2834ce193ca949799ef063e34a2cfa0b-Heidi.Rebel]; Caccomo, Stephanie
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=950c32cebc4b4f80b302c50cf3 1¢8524-Stephanie.C]; Pines, Wayne *
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=0e9f5ce0254041a48966c10d0c38befS-Wayne.Pines]

Subject: RE: FLAGGING -- NYT on HCQ

Fine here.

From: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>

Sent: Tuesday, June 16, 2020 3:46 PM

To: Felberbaum, Michael <Michael.Felberbaum @fda.hhs.gov>

Cc: Shah, Anand <Anand.Shah@fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi
<Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie <Stephanie.Caccomo @fda.hhs.gov>; Pines, Wayne *
<Wayne.Pines@fda.hhs.gov>; Amin, Stacy <Stacy.Amin@fda.hhs.gov>

Subject: Re: FLAGGING -- NYT on HCQ

lam good with it. Others?

Sent from my iPhone

On Jun 16, 2020, at 3:42 PM, Felberbaum, Michael <Michael.Felberbaum @fda.hhs.gov> wrote:

OK to send back?

From: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>

Sent: Tuesday, June 16, 2020 3:21 PM

To: Felberbaum, Michael <Michael.Felberbaum @fda.hhs.gov>

Ce: Shah, Anand <Anand.Shah@fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi
<Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne *
<Wayne.Pines@fda.hhs.gov>; Amin, Stacy <Stacy.Amin@fda.hhs.gov>

Subject: Re: FLAGGING -- NYT on HCQ

Thx

Sent from my iPhone


Moving Steve to bcc
Dear All —

Following up from yesterday’s discussion, Jeet worked with CDER on a proposed statement that provides scientific
rationale for our decision.

We welcome your feedback.
Thank you

Anand

Original Appointmen:
From: Hahn, Stephen <SH1@fda.hhs.gov>

Sent: Monday, June 15, 2020 9:44 PM

To: Hahn, Stephen; Lenihan, Keagan; Shah, Anand; Caliguiri, Laura; Rebello, Heidi; Caccomo, Stephanie; Felberbaum,
Michael; Pines, Wayne *

Subject: Comms Touch Base: HCQ

When: Tuesday, June 16, 2020 8:15 AM-8:30 AM (UTC-05:00) Eastern Time (US & Canada).

Where: (6) (6)


Attached for your review and comments are draft opening remarks to be given by Dr. Shah to an upcoming
stakeholder call with the autoimmune community to explain the scientific basis behind the revocation
of emergency use authorizations for chloroquine and hydroxychloroquine.

If you could provide your edits and comments by 6 pm this evening that would be greatly appreciated. Please
make any edits in the SharePoint document below:

http://sharepoint.fda.gov/orgs/OC-
OCET/OCETdocs/nCoV/Shared%20Documents/SH%20talking%20points/2020-06-
26%20Shah%20remarks%20for%20stakeholder%20call%200n%20HQ.1.docx

Thanks,

Alex

ALEX WOHL, J.D. |

WRITER-EDITOR; SPEECHWRITER

Office of Editorial and Creative Services | Office of External Affairs
U.S. Food and Drug Administration

w: 240-402-0363 | m: 202-573-2344


ALEX WOHL, J.D. |

WRITER-EDITOR; SPEECHWRITER
Office of Editorial and Creative Services | Office of External Affairs

U.S. Food and Drug Administration

w: 240-402-0363 | m: (6)(6)NNNNN


[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=126c81b1a5804e00bb58ee32cec1a0b9-ZHANGX]; Arya, Vikram
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=7d1c11aca00f4309bdff17585c28a16b-ARYAV]; Swank, Kimberley
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=e628b3cb89fd43a6b6a6e62feab03a5f-Kimberley.S]; McCartan, Kate
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=06133f58c95 14566b51e14c43c463619-Kate.McCart]; Kapoor, Rachna
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=43a5103afc8c4c03aaad09d3bc9d25e0-KAPOORR]; Gada, Neha
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=a9d0cda311464b76b35d23707 fa0afec-GADAN]; Diak, Ida-Lina
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=cc86c49867a84b549f1bfcb35507c7e6-DIAKI]; Pratt, Natasha
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=1bed8e9f9cb140348d376c67f9966ba2-CHENCH]; Falconer, Monique
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=0f07eac8afa8470cad2aaa63d5acb73a-FALCONERM]; Buhse, Lucinda
(/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=03c54017a02447e1aea701cbe7cl1laab-BUHSEL]; Liu, Qi (CDER)
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=631d5e6ef4374a05976bc3d0a16f1e30-liuq]; Bergman, Kimberly
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=e8c7d96490364402908eda50066c557b-BERGMANK]; Zheng, Jenny H.
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=0a2425c4f44c44ec8a6a935b1daa8578-ZHENGIJE]; Reynolds, Kellie S
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=86906735a6284de08cefdab86da6fa99-REYNOLDSK]

cc: Lee, Marguerite [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=6e40a85 7adef4a7587b71992d79809e0-Marguerite.]; Wanke, Hilary
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=3595b19b6Seb4cdcb19eSc4f7dc11706-Hilary. Wank]; Helms Williams, Emily
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=873be46f1b1a4d2b8df3fe6 713 7cbdc8-HELMSWILLIA]; Litigation Hold
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=4ae774ddb5d84977aac503990e4b37 10-Litigation]; OP Policy Review Team
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=880566a7249e4495973f6957997d7031-OP Policy R]

Subject: ACTION REQUIRED: Retention of records relating to EUA for HCQ/CCQ,

Importance: High
All:

Please be advised that a lawsuit has been filed in the United States District Court for the Western District of
Michigan challenging the now-revoked emergency use authorization (EUA) for hydroxychloroquine sulfate and
chloroquine phosphate (HCQ/CQ). The suit was filed by the Association of American Physicians and Surgeons against
FDA, Commissioner Hahn, the Biomedical Advanced Research and Development Authority (BARDA), Acting Director
Disbrow, the Department of Health and Human Services, and Secretary Azar. The Plaintiff makes allegations about the
circumstances surrounding the issuance and revocation of the EUA and the HCQ in the Strategic National Stockpile
(SNS). Plaintiff asks the court to order the Defendants to distribute HCQ from the stockpile promptly to members of the
public who have valid prescriptions and to enjoin the Defendants from placing any restrictions on HCQ .

While this litigation is pending, the agency is under an obligation to retain documents and communications, including
emails and other electronically stored information, that are potentially relevant to the case. Such documents and
communications include, but are not limited to:


From: Felberbaum, Michael [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=4819A643CA2945CDB1A2631B83E69673-MICHAEL.FEL]

Sent: 6/16/2020 6:18:46 PM

To: Amin, Stacy [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=cb3764b7438648838c22881a06fc6afb-Stacy.Amin]; Pines, Wayne *
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=0e9f5ce0254041a48966c10d0c38befS-Wayne.Pines]; Lenihan, Keagan
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=ee7320ee8c184d66bfd521b0105d17d2-Keagan.Leni]

ce: Shah, Anand [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=e2172ebbd96946c08e189fd612855f51-Anand.Shah); Caliguiri, Laura
{/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=aa086f2d6c0346c49e996932d86ac62e-Laura.Calig]; Rebello, Heidi
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=2834ce193ca949799ef063e34a2cfa0b-Heidi.Rebel]; Caccomo, Stephanie
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=950c32cebc4b4f80b302c50cf3 1¢8524-Stephanie.C]

Subject: RE: FLAGGING -- NYT on HCQ

Shared the response with the reporter. Told we should expect the story to go online tonight. Will flag when | see.

From: Felberbaum, Michael

Sent: Tuesday, June 16, 2020 4:48 PM

To: Amin, Stacy <Stacy.Amin@fda.hhs.gov>; Pines, Wayne * <Wayne.Pines@fda.hhs.gov>; Lenihan, Keagan
<Keagan.Lenihan@fda.hhs.gov>

Cc: Shah, Anand <Anand.Shah@fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi
<Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie <Stephanie.Caccomo @fda.hhs.gov>

Subject: RE: FLAGGING -- NYT on HCQ

Thanks. Will let you know if | hear anything different from ASPA.

From: Amin, Stacy <Stacy.Amin@fda.hhs.gov>

Sent: Tuesday, June 16, 2020 4:03 PM

To: Pines, Wayne * <Wayne.Pines@fda.hhs.gov>; Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Felberbaum,
Michael <Michael.Felberbaum@fda.hhs.gov>

Cc: Shah, Anand <Anand.Shah@fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi
<Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>

Subject: RE: FLAGGING -- NYT on HCQ

(b) (5) | is ok with me.

From: Pines, Wayne * <Wayne.Pines@fda.hhs.gov>

Sent: Tuesday, June 16, 2020 4:02 PM

To: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum @fda.hhs.gov>
Cc: Shah, Anand <Anand.Shah@fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi
<Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Amin, Stacy

<Stacy.Amin@fda.hhs.gov>
Subject: Re: FLAGGING -- NYT on HCQ

| would just suggest (BY)


. Web updates:

. Stakeholders:

° CDER: CURE ID discussion at International Society for Neglected Tropical Diseases webinar — Heather
Stone (OMP) [slides] 6/18

° CDER: MedDRA User's Group webinar: Impact of COVID-19 on pharmacovigilance, Sonja Brajovic (OSE) —
6/18

° SES: Dr. Hahn to provide opening remarks on call with American Hospital Association (membership
meeting about 700 members) - 6/18

. Consumers & patients:

° ws

. Internal

°

Pending release, week of June 15 and beyond [ail internal confidential]

. Press statements:
Daily roundups (M-F)
° Inspection-related updates:
. Foreign inspections with update on drug UFAs ~ week of 6/15
. Foods interim update based on AFDO response, focus on food safety going into summer season
- maybe week of 6/15
. Domestic inspections update—as we have more clarity around resuming domestic inspections,
will provide - timing TBD (longer term)
. Dr. Hahn media:
° Twitter Q&A initiative responses [SP link,
. CDRH:
° Upcoming IIE guidances:
. CDRH: Update to 506J guidance on device shortage reporting ~ 6/18 or 6/19
° EUAs:
. on
° Web updates:
. WLs - Operation Fraud Alert - fraudulent COVID products (CDRH, Jeremy Kahn)~mid June or
later
° Stakeholders:
. CDRH: Communications to alert HCPs on Certain COVID-19 Serology/Antibody Tests Should Not
Be Used (scope broadened beyond Phamatech) ~later week of 6/15, or week of 6/22
. CDRH: New FAQ web page - Importing (+ Registration and Listing) Medical Devices During the
COVID-19 Pandemic [SP link] ~later week of 6/15, or week of 6/22
. CDRH: Webinar series on PPE (imported respirators) — next 6/23 (comms likely ~ 6/17)
° Beyond this week:
. IIE guidances:
. Enforcement Policy for Viral Transport Media During the Coronavirus Disease 2019
(COVID-19) Public Health Emergency ~week of 6/22 or later
. Recalls of Medical Devices and Corrective Actions/Repairs of Electronic Products During
the Coronavirus Disease 2019 (COVID-19) Public Health Emergency — week of 6/22 or later
. Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee
Applications — week of 6/22 or later
. Enforcement Policy for Non-invasive Electrical Stimulation Devices Intended for
Treatment of Major Depressive Disorder (MDD) — week of 6/22 or later
. Enforcement Policy for Digital Health and Stimulation Therapeutic Devices for Physical

Rehabilitation — week of 7/5 or later


From: Finnen, April [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=43D74B830BB1D429184B0D908 1EFE19BF-APRIL.FINNE]

Sent: 6/9/2020 7:49:25 AM

To: 2019-nCoV FDA IMG JIC [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=289715a1146847558b07a33ccab6bccf-2019-nCoV F}

cc: Mair, Michael [/o=ExchangeLabs/ou=Exchange Administrative Group

(FYDIBOHF23SPDLT)/cn=Recipients/cn=f4511bdad7564d7fac7eadc7961467ab-Michael.Mai]; Hinton, Denise
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=85feca0be0694803be6030e97c7 b4adb-HINTOND]

Subject: 10:00 JIC notes

Attachments: 20200609_JICMeetingNotes.docx

JIC daily check-in M-F, 10:00 — 10:30 a.m. WebEx only. For first part of meeting, we will run down status of current
items, then focus on hot topics, if any. After the meeting, updated notes will be available in SharePoint (JIC meeting
notes folder).

Reminders/notes/resources:

° June 10, 2020: COVID-19 and Communities of Color: Implications for Health Literacy NASEM webinar, 1:00 - 2:00
p.m.
° Just FYI - When 511 Epidemiologists Expect to Fly, Hug and Do 18 Other Everyday Activities Again (NY Times)

TODAY’S FOCUS DISCUSSION (Second half of meeting)
. Hot topics for the group

Pending, from previous discussions:
. 6/5 - update on plans RE HCQ/CQ revocation, if any? (Anna S. looking into CDER division plans)
° 5/27 - future of FEMA How to Help web page (Brooke Courtney + web team)

Press/Media Engagements:

. What is Dr. Hahn up to today
. White House (TPs, when needed: Michael F.)
Then, by area:

. Press releases/media/WHTF
. CDRH

. CDER

. CBER

. CFSAN

. CVM

. ORA

. OPLIA

. CTP

. occ

. OL

. Consumer

. Stakeholder

. Web

° Social

. Internal

. Meeting report-outs



From: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 10:57 AM

To: Guram, Jeet <Jeet.Guram @fda.hhs.gov>; Shah, Anand <Anand.Shah@fda.hhs.gov>; Lenihan, Keagan
<Keagan.Lenihan@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum@fda.hhs.gov>; Caliguiri, Laura
<Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie
<Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne * <Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle
<Dayle.Cristinzio@fda.hhs.gov>; Shreeve, Chris <Christine.Kuethe@fda.hhs.gov>

Cc: Clarke, Mary Beth <Marybeth.Clarke@fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ

Adding Chris Shreeve, who can make sure this goes through CDER clearance, DAV in particular since they wrote the
memo. | recommend that Don Beers also review.
Patrizia

From: Guram, Jeet <Jeet.Guram@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 10:53 AM

To: Shah, Anand <Anand.Shah@fda.hhs.gov>; Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Felberbaum, Michael
<Michael.Felberbaum @fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi
<Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne *
<Wayne. Pines @fda.hhs.gov>; Cristinzio, Dayle <Dayle.Cristinzio@fda.hhs.gov>

Cc: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Clarke, Mary Beth <Marybeth.Clarke@fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ

Attaching the document as well

Jeet Guram, M.D.
Senior Advisor, Office of the Commissioner
Food and Drug Administration

+1 (202) 230-0451 | jeet.guram@fda.hhs.gov

From: Shah, Anand <Anand.Shah@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 10:52 AM

To: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum@fda.hhs.gov>;
Guram, Jeet <Jeet.Guram@fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi
<Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne *
<Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle <Dayle.Cristinzio@fda.hhs.gov>

Cc: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Clarke, Mary Beth <Marybeth.Clarke @fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ

+Patrizia and Mary Beth for awareness. Jeet will be reaching out to CDER shortly to help pull it all together
Anand

From: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 10:39 AM

To: Shah, Anand <Anand.Shah@fda.hhs.gov>; Felberbaum, Michael <Michael.felberbaum@fda.hhs.gov>; Guram, Jeet
<Jeet.Guram @fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>;
Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne * <Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle

<Dayle.Cristinzio@fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ



From: Booze, Kristen [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=86338261BF6646CS59BF8CF7C18D12DE3-KRISTEN.BOO]

Sent: 6/14/2020 3:51:57 PM

To: Sadove, Elizabeth [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=fd45c627000d4f34b9db362ff2b6af4b-SADOVEE]

cc: Mair, Michael [/o=ExchangeLabs/ou=Exchange Administrative Group

(FYDIBOHF23SPDLT)/cn=Recipients/cn=f45 11bdad7564d7fac7eadc7961467ab-Michael.Mai]; Hinton, Denise
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=85 feca0be0694803be6030e97c7b4adb-HINTOND)]; Finnen, April
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=43d74b30bb1d429184b0d908 Lefe19bf-April.Finne]

Subject: RE: CDER EUA actions QAs

Thanks! I’ll review and let you know if | have any questions.

From: Sadove, Elizabeth <Elizabeth.Sadove@fda.hhs.gov>

Sent: Sunday, June 14, 2020 3:47 PM

To: Booze, Kristen <Kristen.Booze@fda.hhs.gov>

Cc: Mair, Michael <Michael.Mair@fda.hhs.gov>; Hinton, Denise <Denise.Hinton@fda.hhs.gov>; Finnen, April
<April.Finnen@fda.hhs.gov>

Subject: RE: CDER EUA actions QAs

Attached are my comments and proposed edits.

CC:ing for others in OCET, in case they have any additional items to add, recognizing you have to move this along to the
next person...

From: Booze, Kristen <Kristen.Booze @fda.hhs.gov>
Sent: Sunday, June 14, 2020 2:26 PM

To: Sadove, Elizabeth <Elizabeth.Sadove@fda.hhs.gov>
Subject: RE: CDER EUA actions QAs

Importance: High

Hi Liz,

Thanks again for taking a look at these QAs. Attached are two sets of external QAs (they will be posted online):

1) For the HCQ/CQ revocation — These are the QAs we are most concerned with OCET reviewing. These will be
posted on the EUA page to replace old QAs about the HCQ/CQ EUA. Some of this information is flagged for final checking
against the memo, when it is final.

2) For the remdesivir revised FSs — feel free to look over, but OCET likely won’t have edits. These will be added to
already existing external QA document for remdesivir EUA.

Please let me know if you have any edits by 3:30, if possible.

Many thanks,
Kristen

From: Sadove, Elizabeth <Elizabeth.Sadove@fda.hhs.gov>
Sent: Sunday, June 14, 2020 12:34 PM

To: Booze, Kristen <Kristen.Booze@fda.hhs.gov>

Subject: RE: CDER EUA actions QAs


Documents, electronically stored information, and tangible items that were considered, directly or
indirectly, during the decision-making process in connection with the request for and issuance of the
EUA, the request for and revocation of the EUA, the donation of HCQ to the SNS, and the disposition of
HCQ from the SNS after the EUA was revoked.

During the course of any lawsuit, the opposing party may use the discovery process to obtain agency records about the
allegations related to the case. The law requires FDA to preserve such information in whatever form it is generated and
maintained. Therefore, the agency requires your assistance to preserve documents and other evidence, including
electronic data, in connection with the subject of these lawsuits.

As an FDA employee, you are required to preserve all documents and data related to the subject of these lawsuits,
including information stored in hard copy, on computer systems, on removable or portable electronic storage media,
and on your personal computer, if used to create agency records. All electronically stored data, including e-mails and
other electronic communication, word processing documents, spreadsheets, databases, calendars, telephone voice
mails, and other kinds of media, must be retained until resolution of this matter. In addition, you must retain non-
electronic documents and evidence in whatever form, including personal or desk files, calendars, notes,
correspondence, and other things relevant to the case. Any routine data destruction policies related to these records
must be discontinued until further notice from me.

You do not need to collect and produce the documents/electronic data at this time; rather, we are only seeking
to preserve and prevent the destruction of existing information. Failure to preserve and retain information may
result in sanctions against the agency. Consequently, if you are unsure whether certain information should be
preserved, err on the side of caution and preserve the information until you have discussed the issue with [indicate who
should be contacted]. If production of some or all of the material is required at a later date, you will receive further
instructions from an attorney assigned to this matter. Also, if you have any questions about how to preserve
electronically stored information, please contact me.

Although you are not required to collect documents/electronic data at this time, where possible, it is advisable
to segregate potentially relevant information. This can help ensure it is not inadvertently destroyed (e.g., by operation
of an electronic system or according to prior record retention policies) and can facilitate ease of retrieval if production
becomes necessary.

In addition, please make sure that this message is distributed to all personnel in your office who may be involved
in, or have information pertaining to, this lawsuit. Because this message is confidential, however, do not send it outside
the agency without first discussing it with me or an attorney from my office. Please send me the names of the people
to whom you forward this message. | also advise that you document the specific actions taken by you and your office in
response to this message.

If you or your office have in your possession, custody, or control any documents/electronic data within the
category described above, or if you are responsible for an office that has any documents/electronic data, you must
preserve and retain the information through the time that you are either instructed to collect it or informed that the
preservation instruction is no longer in effect. As stated above, no documents/electronic data need be collected or
produced at this point.

Please click the “yes” voting button above to confirm that you have received this notice, understand your obligations,
and agree to comply with the instructions.

If you have any questions about your obligations to preserve information, please contact me at 240-381-3334 or email

me at john.emery@fda.hhs.gov.

John “Mac” Emery
Paralegal Specialist


From:

Sent:
To:

Emery, John [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP.
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=C68B7BBB994D48FDB2F6F6802BFDB605-JOHN.EMERY]

7/7/2020 3:43:39 PM

Baumgartner, Kristofer [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=8f49b4b6cfcf4d249f8b1802a2c7dc40-BAUMGARTNER]; Shreeve, Chris
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=571674b26ca64f578288f39264470299-Christine.K]; Hunt, Alison
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=c0f683a75ebd4235abf90d887b5f7293-Alison.Hunt]; Tantillo, Andrew
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=c43045bfeef846fa99daa0c3d4772a1c-Andrew. Tant]; Gross, Karas
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=0b6d3dc4ee4b415d86ec634c536453b6-Kara.Gross]; McBride, Maren
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=b65d2b38307f4b489e266d2178c46793-Maren.Kahn]; Anderson, Erika
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=98606928b9a64edfb25abale3573fdfe-Eranders]; Finnen, April
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=43d74b30bb1d429184b0d9081efe19bf-April.Finne]; Cristinzio, Dayle
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=b5a8dc4e587946fa938714a962df4246-Dayle.Crist]; Walsh, Sandy
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=c61503c4e7884fc28b9ef6cb8f25 14ec-Sandy.Walsh]; Caliguiri, Laura
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=aa086f2d6c0346c49e996932d86ac62e-Laura.Calig]; Caliguiri, Laura
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=aa086f2d6c0346c49e996932d86ac62e-Laura.Calig]; Rebello, Heidi
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=2834ce193ca949799ef063e34a2cfa0b-Heidi.Rebel]; Lynch, Sarah
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=d24ee4a4fc6241f48110d6b35e6704ed-Sarah.Lynch]; Black, Jennifer
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=aaf8a19f3672492293a7c1b2d1498059-Jennifer.Bl]; Meister, Karen G
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=7f2cdcd99e784c6cb3e8bf491fee037f-KMEISTER]; Alexander, Nicholas
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=08e1fd211c4a4c96be426218bd0711e9-Nicholas.Al]; Sykes, LaShawn
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=95f500b32a404714b 1ec349f9d002c4c-Lashawn.Syk]; Kimberly, Brad
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=08bc909ed76d49868a5 ff92c3c70fb72-Bradley.Kim]; Schipper, Jodi
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=2373b9ecd1654e65992a9a5fbeeS59630-SCHIPPERJ]; Morin, Steve
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=0e7ada1e856e450989eca9 2Sefcf201a-MORINS]; Cooper, Mildred
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=aa838567ff8147ffb5933a8a698133b0-Mildred.Coo]; Wohl, Alexander
[/o=ExchangeLabs/ou=Exchange Administrative Group

(FYDIBOHF23SPDLT)/cn=Recipients/cn=3 ee6d17fe8114d16bc6244f59d9d00b4-Alexander.W]; Mair, Michael
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=f4511bdad7564d7fac7eadc7961467ab-Michael.Mai]; Guevara, Bessy
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=58097ba8edea47afb3338e67 1a43dc04-Bessy.Gueva]; Klimczak, Katherine
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=01a6c20534774be590c50f0d455c8 1de-Katherine.K]; Van Pool, Kendall
[(/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=db264f9a066044fc82aca6b12698467e-Kendall.Van]; Leggin, Brooke



Tel: 240-402-5772
ch reeve@fda hhs.qov

From: Guram, Jeet <Jeet.Guram@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 3:20 PM

To: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Shah,
Anand <Anand.Shah@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum @fda.hhs.gov>; Caliguiri, Laura
<Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie
<Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne * <Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle
<Dayle.Cristinzio@fda.hhs.gov>; Shreeve, Chris <Christine.Kuethe@fda.hhs.gov>

Cc: Clarke, Mary Beth <Marybeth.Clarke@fda.hhs.gov>; Beers, Donald <Donald.Beers@fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ

No problem — looping in Don Beers as well, here is a first draft for review.

Jeet Guram, M.D.
Senior Advisor, Office of the Commissioner
Food and Drug Administration

+1 (202) 230-0451 | jeet.guram@fda.hhs.gov

From: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 11:23 AM

To: Guram, Jeet <Jeet.Guram @fda.hhs.gov>; Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Shah, Anand
<Anand.Shah@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum @fda.hhs.gov>; Caliguiri, Laura
<Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie
<Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne * <Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle
<Dayle.Cristinzio@fda.hhs.gov>; Shreeve, Chris <Christine.Kuethe@fda.hhs.gov>

Cc: Clarke, Mary Beth <Marybeth.Clarke@fda.hhs.gov>

Subject: RE: Comms Touch Base: HCQ

Thank you, Jeet.

From: Guram, Jeet <Jeet.Guram @fda.hhs.gov>

Sent: Wednesday, June 17, 2020 11:07 AM

To: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Shah, Anand <Anand.Shah@fda.hhs.gov>; Lenihan, Keagan
<Keagan.Lenihan@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum@fda.hhs.gov>; Caliguiri, Laura
<Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie
<Stephanie.Caccomo @fda.hhs.gov>; Pines, Wayne * <Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle
<Dayle.Cristinzio@fda.hhs.gov>; Shreeve, Chris <Christine.Kuethe@fda.hhs.gov>

Cc: Clarke, Mary Beth <Marybeth.Clarke@fda.hhs.gov>

Subject: RE: Comms Touch Base: HCQ

Jeet Guram, M.D.
Senior Advisor, Office of the Commissioner
Food and Drug Administration


<Dayle.Cristinzio@fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ

Thanks!

From: Shah, Anand <Anand.Shah@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 10:35 AM

To: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum @fda.hhs.gov>;
Guram, Jeet <Jeet.Guram@fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi
<Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne *
<Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle <Dayle.Cristinzio@fda.hhs.gov>

Subject: RE: Comms Touch Base: HCQ.

Totally agree — we will build all this in and send a revised version shortly

From: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 10:33 AM

To: Shah, Anand <Anand.Shah@fda.hhs.gov>; Felberbaum, Michael <Michael.felberbaum@fda.hhs.gov>; Guram, Jeet
<Jeet.Guram@fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>;
Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne * <Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle
<Dayle.Cristinzio@fda.hhs.gov>

Subject: RE: Comms Touch Base: HCQ

From: Shah, Anand <Anand.Shah@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 10:29 AM

To: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum @fda.hhs.gov>;
Guram, Jeet <Jeet.Guram@fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi
<Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne *
<Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle <Dayle.Cristinzio@fda.hhs.gov>

Subject: RE: Comms Touch Base: HCQ

All good feedback. Would like to emphasize that we do not regulate the (BY) yyy
ee

From: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 10:26 AM

To: Felberbaum, Michael <Michael.Felberbaum @fda.hhs.gov>; Shah, Anand <Anand.Shah@fda.hhs.gov>; Guram, Jeet
<Jeet.Guram @fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>;
Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne * <Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle

<Dayle.Cristinzio@fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ



From: Beers, Donald

Sent: Friday, June 12, 2020 11:44 AM

To: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Farley, John <John.Farley@fda.hhs.gov>; Sipes, Grail
<Grail.Sipes@ fda.hhs.gov>

Subject: RE: FOUO INFORMATION NOT RELEASABLE UNDER FOIA

From: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>
Sent: Friday, June 12, 2020 11:36 AM
To: Beers, Donald <Donald.Beers@fda.hhs.gov>; Farley, John <John.Farley@fda.hhs.gov>; Sipes, Grail

<Grail.Sipes@fda.hhs.gov>
Subject: FW: FOUO INFORMATION NOT RELEASABLE UNDER FOIA

(©)@just called me. They need our comments asap, so that they can finalize the memo and send back to us, to be
forwarded to Commissioner Hahn.
Patrizia

From:

Sent: Friday, June 12, 2020 11:33 AM

To: Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Farley, John <John.Farley@fda.hhs.gov>; Beers, Donald
<Donald.Beers@fda.hhs.gov>

Ces Dislorow, Gary (OS) ()i(G) lillie)

ee
Subject: FOUO INFORMATION NOT RELEASABLE UNDER FOIA

Patrizia, John and Don,

Please see our revised final draft. Comments or suggested edits are welcome.

©)
<< File: BARDA EUA 039 Withdrawal Letter FINAL.docx >>

Deputy Assistant Secretary

Director, Medical Countermeasure Programs
Biomedical Advanced Research and Development Authority
BARDA

Assistant Secretary for Preparedness and Response ASPR
Department of Health and Human Services

330 Independence Avenue, S.W. Room 640 G

Washington, D.C. 20201
Office: 202-260-0899

Mobile: hae
Fax: 20;
emai: (6)(6) nn


Cc: Clarke, Mary Beth <Marybeth.Clarke@fda.hhs.gov>; Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Cavazzoni,
Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Shah, Anand <Anand.Shah@fda.hhs.gov>; Felberbaum, Michael

<Michael.Felberbaum @fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi
<Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne *

<Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle <Dayle.Cristinzio@fda.hhs.gov>; Guram, Jeet <Jeet.Guram@fda.hhs.gov>
Subject: RE: Comms Touch Base: HCQ.

Thank you, Don. We will get it through CDER as quickly as possible and then back to you.

Chris

From: Beers, Donald <Donald.Beers@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 4:42 PM

To: Shreeve, Chris <Christine.Kuethe@fda.hhs.gov>; Guram, Jeet <Jeet.Guram @fda.hhs.gov>

Cc: Clarke, Mary Beth <Marybeth.Clarke@fda.hhs.gov>; Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Cavazzoni,
Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Shah, Anand <Anand.Shah@fda.hhs.gov>; Felberbaum, Michael
<Michael.Felberbaum @fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi
<Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne *
<Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle <Dayle.Cristinzio@fda.hhs.gov>

Subject: RE: Comms Touch Base: HCQ.

Chris,

lam glad to give my feedback now, but it would probably be good for me to look again if there are further revisions. |
have a couple of comments with potential edits on the last page of the attached.

Don

From: Shreeve, Chris <Christine.Kuethe@fda.hhs.gov>

Sent: Wednesday, June 17, 2020 3:22 PM

To: Guram, Jeet <Jeet.Guram@fda.hhs.gov>

Cc: Clarke, Mary Beth <Marybeth.Clarke@fda.hhs.gov>; Beers, Donald <Donald.Beers@fda.hhs.gov>; Lenihan, Keagan
<Keagan.Lenihan@fda.hhs.gov>; Cavazzoni, Patrizia <Patrizia.Cavazzoni@fda.hhs.gov>; Shah, Anand
<Anand.Shah@fda.hhs.gov>; Felberbaum, Michael <Michael.Felberbaum @fda.hhs.gov>; Caliguiri, Laura
<Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie
<Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne * <Wayne.Pines@fda.hhs.gov>; Cristinzio, Dayle
<Dayle.Cristinzio@fda.hhs.gov>

Subject: RE: Comms Touch Base: HCQ.

Hi,
Just checking. Has this gone through CDER or will it go there after Don clears? Thanks!

Chris

Chris Shreeve
Director, Office of Communications

Center for Drug Evaluation and Research
U.S. Food and Drug Administration

Tel: 240-402-5772
chris.shreeve@fda.hhs.gov



. Spectrum Solutions LLC, SDNA-1000 Saliva Collection Device

. Rapid Rona home collection kit using Hologic's Panther Fusion COVID-19 EUA assay —
6/18

. Additions to umbrella EUAs for various devices, ventilators, and support accessories

. CDER:

° Revised EUA fact sheets for remdesivir, to update info on dosing and clinical trials, and add info on
HCQ/CQ drug interaction with remdesivir (social, DR) ~6/12 or week of 6/15

° Beyond this week:

. Guidance: COVID-19 infection in Employees in Pharmaceutical Manufacturing (+Daily Roundup,
listserv, reactive QAs) —late June

. Guidance: Manufacturing, Supply Chain, and Drug Inspections During COVID-19 Public Health
Emergency - Questions and Answers (+Daily Roundup) — late June

. Guidance: Statistical Considerations for Clinical Trials During the COVID-19 Public Health
Emergency - TBD

. Health Affairs Blog: CDER’s Contributions Towards Protecting Public Health During the COVID-19
Pandemic By Patrizia Cavazzoni, M.D. [SP link] - June/July

. CBER:

° Use of stem cells (comms and target date TBD)

. CFSAN:

° Checklist (w/CVM): Employee Health and Food Safety Checklist for Human and Animal Food Operations
During COVID-19 [SP link]

. CVM:

° (see consumer below for pet video update)

. ORA:

° Guidance: Disinfection of Surfaces on Interstate Conveyances (OMA clearance)

. OPLIA:

° Potentially a new blog by Europe office, emphasizing EU collaboration (platform/details TBD)

° Feature on ORA employee's experience being in India during pandemic and visiting hydroxychloroquine
plant [internal to ORA + external comms TBD]

. CTP:

° we

. Consumer & patient updates:

° Language translation of FAQs on face coverings and for DIY ventilator makers

° Getting Smarter About Food Safety: The Pandemic and Lessons Learned (based on similar FDA Voices)
° Video on COVID-19 and pets (companion to previously published Consumer Update) - week of 6/8

. Web updates:

° OC/CDRH: User-friendly tool on website for labs that need information on test component substitutes
when supply issues arise (+ webinar)

° OCET: New page: Updates on activities performed under the rapid response to COVID-19 3D printing
MOU (w/NIH, VA) [SP link] ~maybe week of 6/8

. Stakeholders:

° C-PATH press release: C-Path Launches CURE Drug Repurposing Collaboratory to Accelerate

Identification of Existing Drugs to Treat Infectious Diseases, Including COVID-19 (FDA-funded work, including an FDA
quote) - week of 6/8? [SP link]

° CDER: Virtual/remote human factor validation testing follow-up (internal reactive Q&A)

° OEA: Stakeholder toolkit for Convalescent Plasma, including fact sheet, tweets, and newsletter content
(some materials in toolkit now available in Spanish) - likely week of 6/8

° Drug Information Association (DIA) 2020 Virtual Global Annual Meeting: Regulatory Agility Under COVID
19 -Jeannie David (DSS) — 6/16

° SES: Dr. Hahn to provide opening remarks on call with American Hospital Association (membership

meeting about 700 members) - planning phase - 6/18
° MedDRA User's Group webinar: Impact of COVID-19 on pharmacovigilance, Sonja Brajovic (OSE) — 6/18


Following up from yesterday’s discussion, Jeet worked with CDER on a proposed statement that provides scientific
rationale for our decision.

We welcome your feedback.

Thank you

Anand

-----Original Appointment-----

From: Hahn, Stephen <SH1@fda.hhs.gov>

Sent: Monday, June 15, 2020 9:44 PM

To: Hahn, Stephen; Lenihan, Keagan; Shah, Anand; Caliguiri, Laura; Rebello, Heidi; Caccomo, Stephanie; Felberbaum,
Michael; Pines, Wayne *

Subject: Comms Touch Base: HCQ.

When: Tuesday, June 16, 2020 8:15 AM-8:30 AM (UTC-05:00) Eastern Time (US & Canada).

Where: (6)(6)


From: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>

Date: June 16, 2020 at 3:45:49 PM EDT

To: Felberbaum, Michael <Michael.Felberbaum @fda.hhs.gov>

Ce: Shah, Anand <Anand.Shah@fda.hhs.gov>, Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>, Rebello, Heidi
<Heidi.Rebello@fda.hhs.gov>, Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>, Pines, Wayne *
<Wayne.Pines@fda.hhs.gov>, Amin, Stacy <Stacy.Amin@fda.hhs.gov>

Subject: Re: FLAGGING -- NYT on HCQ

lam good with it. Others?

Sent from my iPhone

On Jun 16, 2020, at 3:42 PM, Felberbaum, Michael <Michael.Felberbaum @fda.hhs.gov> wrote:

OK to send back?

From: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>

Sent: Tuesday, June 16, 2020 3:21 PM

To: Felberbaum, Michael <Michael.Felberbaum @fda.hhs.gov>

Ce: Shah, Anand <Anand.Shah@fda.hhs.gov>; Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi
<Heidi.Rebello@ fda.hhs.gov>; Caccomo, Stephanie <Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne *

<Wayne.Pines@fda.hhs.gov>; Amin, Stacy <Stacy.Amin@fda.hhs.gov>
Subject: Re: FLAGGING -- NYT on HCQ

Thx

Sent from my iPhone

On Jun 16, 2020, at 2:53 PM, Felberbaum, Michael <Michael.Felberbaum @fda.hhs.gov> wrote:

Here’s the proposed response to the outstanding Q: SecretarY(b) SE) yyy ay
Zz

From: Felberbaum, Michael

Sent: Tuesday, June 16, 2020 1:13 PM

To: Lenihan, Keagan <Keagan.Lenihan@fda.hhs.gov>; Shah, Anand <Anand.Shah@fda.hhs.gov>

Cc: Caliguiri, Laura <Laura.Caliguiri@fda.hhs.gov>; Rebello, Heidi <Heidi.Rebello@fda.hhs.gov>; Caccomo, Stephanie
<Stephanie.Caccomo@fda.hhs.gov>; Pines, Wayne * <Wayne.Pines@fda.hhs.gov>; Amin, Stacy
<Stacy.Amin@fda.hhs.gov>

Subject: FLAGGING -- NYT on HCQ

INTERNAL — DELIBERATIVE — CONFIDENTIAL

Hi both,


INTERNAL FDA USE ONLY

Agenda and notes — JIC 10:00 a.m. check-in
June 9, 2020

JIC daily check-in M-F, 10:00 — 10:30 a.m. WebEx only. For first part of meeting, we will run down status
of current items, then focus on hot topics, if any. After the meeting, updated notes will be available in
SharePoint (JIC [ HYPERLINK "http://sharepoint. fda. gov/orgs/OC-
OCET/OCETdoces/nCoV/default.aspx?RootF older=%2Forgs%2FOC%2DOCET%2FOCETdocs
%2FnCoV%2FShared%20Documents%2FJIC%20%2D%20FDA%20IMG%2FMeeting%20note
s&FolderCTID=0x012000A3A7A055F609174BBA 12CCDSOBB2BD50& View=%7bAASDS76
D-A152-4B9E-B345-979F92F9C4C9%7d" J).

Reminders/notes/resources:

« June 10, 2020: [ HYPERLINK "https://www.eventbrite.com/e/covid-19-and-communities-of-color-
implications-for-health-literacy-tickets-107601745718" ] NASEM webinar, 1:00 - 2:00 p.m.

e Just FY! - [ HYPERLINK "https://www.nytimes.com/interactive/2020/06/08/upshot/when-
epidemiologists-will-do-everyday-things-coronavirus.htm|" ] (NY Times)

TODAY’S FOCUS DISCUSSION (Second half of meeting)
e Hot topics for the group

Pending, from previous discussions:
« 6/5 - update on plans RE HCQ/CQ revocation, if any? (Anna S. looking into CDER division plans)
« 5/27 - future of FEMA How to Help web page (Brooke Courtney + web team)

Press/Media Engagements:
e What is Dr. Hahn up to today
e White House (TPs, when needed: Michael F.)

Then, by area:

Press releases/media/WHTF
CDRH

CDER

CBER

CFSAN

CcVM

ORA

OPLIA

CTP

occ

OL

Consumer
Stakeholder

Web

Social

Internal

Meeting report-outs

[PAGE \* MERGEFORMAT ]