45640 Federal Register / Vol. 83, No. 175 / Monday, September 10, 2018 / Notices 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft MOU at either 

http://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm or https://

www.regulations.gov. 

Dated: August 31, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–19461 Filed 9–7–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–3272] 

Identifying the Root Causes of Drug 

Shortages and Finding Enduring 

Solutions; Public Meeting; Request for 

Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is announcing a public meeting 

entitled ‘‘Identifying the Root Causes of 

Drug Shortages and Finding Enduring 

Solutions.’’ The purpose of the meeting 

is to give stakeholders, including health 

care providers, patients, manufacturers, 

wholesalers, pharmacists, pharmacy 

benefit managers, veterinarians, public 

and private insurers, academic 

researchers, and the public, the 

opportunity to provide input on the 

underlying systemic causes of drug 

shortages, and make recommendations 

for actions to prevent or mitigate drug 

shortages. Members of Congress have 

asked the Agency to examine the root 

causes and drivers of these shortages, 

and to recommend measures that will 

provide more enduring solutions. To 

this end, the Commissioner has 

convened an inter-Agency task force of 

senior Federal officials of FDA, the 

Centers for Medicare & Medicaid 

Services, the Department of Veterans 

Affairs, and the Department of Defense. 

After receiving input from stakeholders, 

the task force intends to provide a report 

to Congress regarding the root causes of 

drug shortages. The report will also 

include recommendations regarding 

new authorities FDA or other Federal 

agencies could use to help provide 

enduring solutions to shortages. 

DATES: The public meeting will be held 

on November 27, 2018, from 8:30 a.m. 

to 4:30 p.m. Submit either electronic or 

written comments on this public 

meeting by January 11, 2019. See the 

SUPPLEMENTARY INFORMATION section for 

registration date and information. 

ADDRESSES: The public meeting will be 

held at the Washington Marriott at 

Metro Center, 775 12th St. NW, 

Washington, DC 20005. The hotel’s 

phone number is 202–737–2200. 

You may submit comments as 

follows. Please note that late, untimely 

filed comments will not be considered. 

Electronic comments must be submitted 

on or before January 11, 2019. The 

https://www.regulations.gov electronic 

filing system will accept comments 

until midnight Eastern Time at the end 

of January 11, 2019. Comments received 

by mail/hand delivery/courier (for 

written/paper submissions) will be 

considered timely if they are 

postmarked or the delivery service 

acceptance receipt is on or before that 

date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2018–N–3272 for ‘‘Identifying the Root 

Causes of Drug Shortages and Finding 

Enduring Solutions.’’ Received 

comments, those filed in a timely 

manner (see ADDRESSES), will be placed 

in the docket and, except for those 

submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Michie Hunt, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 


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Federal Register / Vol. 83, No. 175 / Monday, September 10, 2018 / Notices 45641 

Ave., Bldg. 51, Rm. 6153, Silver Spring, 

MD 20993, 301–796–3504. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Drug shortages are among the greatest 

challenges health care providers and 

patients face. These shortages can affect 

treatment options and require 

practitioners to make difficult decisions 

that can compromise care, such as 

rationing supplies or using less 

desirable, but more readily available, 

alternative therapies. FDA has acted 

within its statutory authority to prevent 

and mitigate drug shortages. By working 

with industry and other parties, the 

Agency has helped to steadily reduce 

the number of new shortages since a 

peak of 251 new shortages occurred in 

2011, as detailed in the Agency’s 

‘‘Report on Drug Shortages for Calendar 

Year 2017,’’ which is available at 

https://www.fda.gov/downloads/Drugs/ 

DrugSafety/DrugShortages/ 

UCM610662.pdf. 

Despite this success in preventing or 

mitigating individual cases, more can 

and must be done to better understand 

and address the underlying systemic 

factors that are leading to shortages of 

medically necessary drugs. Members of 

Congress have asked the Agency to 

examine the root causes and drivers of 

these shortages, and to recommend 

measures that will provide more 

enduring solutions. To this end, the 

Commissioner has convened an interagency task force of senior federal 

officials of FDA, the Centers for 

Medicare & Medicaid Services, the 

Department of Veterans Affairs, and the 

Department of Defense. After receiving 

input from stakeholders, the task force 

intends to provide a report to Congress 

regarding the root causes of drug 

shortages. The report will also include 

recommendations regarding new 

authorities FDA or other federal 

agencies could use to help provide 

enduring solutions to shortages. 

II. Topics for Discussion at the Public 

Meeting 

We are soliciting input from 

stakeholders concerning the adverse 

consequences of drug shortages, the 

underlying systemic causes and drivers 

of these shortages, and the policies and 

strategies that may help to prevent or 

mitigate them. We welcome any 

relevant information that stakeholders 

wish to share, as all factors contributing 

to shortages are matters of concern. We 

are particularly interested in 

stakeholder input in the following areas: 

A. Assessing the Adverse Consequences 

of Drug Shortages to Patients, Health 

Care Providers, and the Drug Supply 

Chain 

1. Drug Shortages’ Impact on Patients 

a. What clinical impacts have patients 

experienced: e.g., adverse events, 

treatment delays, accelerated disease 

progression, or worsened outcomes due 

to patients’ to using less effective or less 

safe alternatives? 

b. What economic impacts have 

patients affected by drug shortages 

experienced? 

c. Do drug shortages affect patients 

disproportionately by geographic region, 

age, disease or condition, 

socioeconomic status, or other factors? 

Are there specific times of year or 

classes of drugs that see episodic, more 

frequent or more severe shortages? If so, 

why does this happen? 

2. Drug Shortages Impact on Health 

Care Providers 

a. What economic impacts (including 

increased inventory management costs, 

substitution of more expensive drugs for 

drugs in shortage, and increased 

liability from adverse events) have 

health care providers, including 

veterinarians, experienced because of 

drug shortages? 

b. Do the adverse consequences of 

shortages affect providers 

disproportionately by, for example, 

geographic region, clinical area, or other 

characteristics? 

3. Drug Shortages’ Impact on the 

Supply Chain 

a. What economic effects have 

shortages had on key links in the drug 

supply chain: e.g., wholesalers, 

distributors, and pharmacies? 

b. Have certain links in the supply 

chain been disproportionately affected 

by shortages? If so, which ones? 

4. Do available data accurately 

capture the differences among shortages 

(e.g., their severity and duration) that 

may affect their clinical and economic 

adverse consequences? If not, what 

additional data would be needed to 

better capture these differences? 

B. Identifying the Root Causes and 

Drivers of Drug Shortages 

1. What factors affect the likelihood, 

severity, and duration of shortages? Are 

these factors mostly related to raw 

materials, management, and resilience 

of production facilities, or other factors 

such as contracting or market structure? 

Do they differ for various drugs? 

2. What government policies and 

regulations may contribute to drug 

shortages, and how could these be 

modified to prevent or limit impacts of 

drug shortages? 

3. How do manufacturers contribute 

to drug availability or shortages, 

including responses to shortages? 

a. What factors do generic and brand 

manufacturers consider when making 

decisions about whether to seek 

approval for certain drugs, to produce 

and market a drug for which they 

already hold an approved new drug 

application or abbreviated new drug 

application, or to discontinue marketing 

a drug? How do those decisions 

contribute (directly or indirectly) to 

shortages? 

b. How do manufacturers monitor for 

situations that may result in a drug 

shortage? Are there certain indicators 

that are monitored? If so, are the 

potential triggers the same for all drugs, 

for example brand and generic sterile 

injectable drugs? 

c. When manufacturers recognize a 

potential shortage, what options do they 

have for averting one? How easy or 

difficult is it to implement these 

options, and how costly is it to 

implement them? What is the impact of 

government policy or regulation on 

these options? 

d. What factors play a role in 

manufacturers’ decisions to make 

capital investments to expand capacity 

or to modernize infrastructure? 

e. When manufacturers are 

remediating or upgrading a facility, how 

can shortages related to production 

slowdowns and shutdowns be avoided? 

4. Drug supply is controlled through 

contracts among manufacturers, 

distributors, and end users. What 

features of contracts used throughout 

the supply chain contribute to drug 

availability and shortages, including 

responses to shortages? 

a. What is the effect of duration and 

scope (how many and what types of 

drug products are covered by each 

contract, and whether non-drug 

products are bundled into the contract), 

on drug availability or shortage? 

b. How commonly do these contracts 

include incentives such as contingency 

clauses, performance requirements, 

failure-to-supply clauses, or restrictions 

on limiting downstream price increases? 

How large are these incentives 

currently? Are there institutional or 

informational impediments limiting 

greater use of such incentives or 

performance clauses? 

c. What are the implications of 

markups on inventory management 

throughout the supply chain? How 

might these markups contribute to 

shortages, and to response to shortages? 

d. How have the characteristics of 

contracts, and markups at different 

points in the supply chain, changed 

over the past 15 years? 


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45642 Federal Register / Vol. 83, No. 175 / Monday, September 10, 2018 / Notices 

e. What are the implications of these 

contracting provisions and their changes 

for the probability, severity, and 

duration of drug shortages? 

f. How much competition exists 

throughout the supply chain? Over the 

past 15 years, have there been 

challenges to competition and if so, 

what factors are responsible for these 

challenges? For example, has 

consolidation in different parts of the 

supply chain created market barriers to 

entry and reduced competition? If so, 

what effect has the reduction in 

competition had on drug shortages? 

C. Identifying Strategies for Preventing 

or Mitigating Drug Shortages 

1. What policies could the Federal 

Government adopt, and what strategies 

could it implement, that would reduce 

the likelihood, severity, and duration of 

shortages? Would additional authorities 

be necessary or helpful? For example: 

a. Establish a list of ‘‘essential 

medicines’’ for use in preventing and 

mitigating shortages. If such a list were 

established, what should be the criteria 

for inclusion? And how should such a 

list be maintained and administered? 

b. Provide financial incentives, such 

as tax credits or revised reimbursement 

policies: e.g., to allow additional 

payments for drugs in or at risk of 

shortage or to encourage investment to 

expand manufacturing capacity or to 

modernize aging infrastructure, to 

enhance process capability and 

variability control, or to prevent 

manufacturing problems that affect 

product availability; 

c. Allow other entities (e.g., contract 

manufacturers) to fill gaps in supply; 

d. Require risk management plans to 

help manufacturers prepare to respond 

efficiently and effectively to potential 

shortages; 

e. Require the extension of expiration 

dates for drugs in shortage or at risk of 

shortage, where scientifically justified; 

f. Revise trade policies and 

authorities: e.g., to allow federal 

purchasers to buy imported drugs or 

raw materials to prevent or mitigate a 

shortage; 

g. Heighten scrutiny of proposed 

mergers and acquisitions that increase 

market concentration or the likelihood 

of shortages; 

h. Revise payment policies and 

authorities: e.g., that would be coupled 

with a requirement to establish 

contingency plans for supplying 

medicines that go into shortage; and 

i. Federal investment in production 

capacity for essential medicines directly 

related to national security, emergency 

preparedness, and defense. 

2. In designing new policies to 

prevent or mitigate shortages, how can 

the Federal Government avoid creating 

perverse incentives or negative 

cascading effects in the health care 

financing and delivery system? For 

example, how might changes to 

government payment and 

reimbursement affect the other sectors 

of the market? 

3. Are there lessons for the Federal 

Government, or practices that it can 

emulate, from strategies used to prevent 

or mitigate shortages in other 

commodity markets that face shortage 

issues? 

4. What challenges does the global 

nature of drug manufacturing and 

marketing pose for efforts to prevent 

shortages in the U.S. market? 

5. As drug shortages are a national 

problem, what are the sources of 

funding that can be applied to provide 

incentives to remedy the root causes? 

III. Participating in the Public Meeting 

Registration: To register for the public 

meeting, please visit the following 

website: https://healthpolicy.duke.edu/ 

events/drug-shortage-task-force. Please 

provide complete contact information 

for each attendee, including name, title, 

affiliation, address, email, and 

telephone. Registration is free and based 

on space availability, with priority given 

to early registrants. Persons interested in 

attending this public meeting must 

register by Wednesday, November 21, 

2018, midnight Eastern Time. There will 

be no onsite registration. Early 

registration is recommended because 

seating is limited; therefore, FDA may 

limit the number of participants from 

each organization. Registrants will 

receive confirmation when they have 

been accepted. If you are unable to 

attend the meeting in person, you can 

register to view a live webcast of the 

meeting. The Duke-Margolis Center for 

Health Policy will post on its website if 

registration closes before the day of the 

public meeting. 

If you need special accommodations 

due to a disability, please contact Sarah 

Supsiri at the Duke-Margolis Center for 

Health Policy (phone: 202–791–9561, 

email: sarah.supsiri@duke.edu) no later 

than November 20, 2018. 

Streaming webcast of the public 

workshop: This public workshop will be 

webcast live. Persons interested in 

viewing the live webcast may register 

ahead of the event by visiting https://

healthpolicy.duke.edu/events/drugshortage-task-force. The live webcast 

will also be available at the website 

above on the day of the event without 

pre-registration. Archived video footage 

will be available at the Duke-Margolis 

website following the workshop. 

Transcripts: Please be advised that as 

soon as a transcript of the public 

meeting is available, it will be accessible 

at https://www.regulations.gov. It may 

be viewed at the Dockets Management 

Staff (see ADDRESSES). A link to the 

transcript will also be available on the 

internet at https://www.fda.gov/Drugs/ 

DrugSafety/DrugShortages/default.htm. 

Other Issues for Consideration: A 1- 

hour lunch break is scheduled, but food 

will not be provided. There are multiple 

restaurants within walking distance of 

the Washington Marriott at Metro 

Center, 775 12th St. NW, Washington, 

DC 20005. 

All event materials will be provided 

to registered attendees via email prior to 

the workshop and will be publicly 

available at the Duke-Margolis Center 

for Health Policy website at https://

healthpolicy.duke.edu/events/drugshortage-task-force. 

Dated: September 5, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–19612 Filed 9–7–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Vascular and 

Hematology Integrated Review Group; 

Hypertension and Microcirculation Study 

Section. 

Date: October 2–3, 2018. 

Time: 8:00 a.m. to 7:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Embassy Suites at the Chevy Chase 

Pavilion, 4300 Military Road NW, 

Washington, DC 20015. 

Contact Person: Ai-Ping Zou, M.D., Ph.D., 

Scientific Review Officer, Center for 


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