Federal Register / Vol. 86, No. 40 / Wednesday, March 3, 2021 / Notices 12473 

(the Commissioner) on the Center 

Director’s proposal to refuse to approve 

NDA 210934. If Lexicon decides to seek 

a hearing, it must file: (1) A written 

notice of participation and request for a 

hearing (see the DATES section) and (2) 

the studies, data, information, and 

analyses relied upon to justify a hearing 

(see the DATES section), as specified in 

§ 314.200 (21 CFR 314.200). 

As stated in § 314.200(g), a request for 

a hearing may not rest upon allegations 

or denials, but must present specific 

facts showing that there is a genuine 

and substantial issue of fact that 

requires a hearing to resolve. We note in 

this regard that because CDER proposes 

to refuse to approve NDA 210934 based 

on the multiple deficiencies 

summarized above, any hearing request 

from Lexicon must address all of those 

deficiencies. Failure to request a hearing 

within the time provided and in the 

manner required by § 314.200 

constitutes a waiver of the opportunity 

to request a hearing. If a hearing request 

is not properly submitted, FDA will 

issue a notice refusing to approve NDA 

210934. 

The Commissioner will grant a 

hearing if there exists a genuine and 

substantial issue of fact or if the 

Commissioner concludes that a hearing 

would otherwise be in the public 

interest (§ 314.200(g)(6)). If a hearing is 

granted, it will be conducted according 

to the procedures provided in 21 CFR 

parts 10 through 16 (21 CFR 314.201). 

Paper submissions under this notice 

of opportunity for a hearing should be 

filed in one copy. Except for data and 

information prohibited from public 

disclosure under 21 U.S.C. 331(j) or 18 

U.S.C. 1905, submissions may be seen 

in the Dockets Management Staff Office 

between 9 a.m. and 4 p.m., Monday 

through Friday, and on the internet at 

https://www.regulations.gov. This notice 

is issued under section 505(c)(1)(B) of 

the FD&C Act and §§ 314.110(b)(3) and 

314.200. 

Dated: February 25, 2021. 

Patrizia Cavazzoni, 

Acting Director, Center for Drug Evaluation 

and Research. 

[FR Doc. 2021–04342 Filed 3–2–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–1413] 

Michael Gurry: Final Debarment Order 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

issuing an order under the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) permanently debarring Michael 

Gurry from providing services in any 

capacity to a person that has an 

approved or pending drug product 

application. FDA bases this order on a 

finding that Mr. Gurry was convicted of 

a felony under Federal law for conduct 

that relates to the regulation of a drug 

product under the FD&C Act. Mr. Gurry 

was given notice of the proposed 

permanent debarment and an 

opportunity to request a hearing to show 

why he should not be debarred. As of 

October 22, 2020 (30 days after receipt 

of the notice), Mr. Gurry had not 

responded. Mr. Gurry’s failure to 

respond and request a hearing 

constitutes a waiver of his right to a 

hearing concerning this action. 

DATES: This order is applicable March 8, 

2021. 

ADDRESSES: Submit applications for 

termination of debarment to the Dockets 

Management Staff, Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852, 240–402– 

7500, or at https://www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Jaime Espinosa (ELEM–4029) Division 

of Enforcement, Office of Strategic 

Planning and Operational Policy, Office 

of Regulatory Affairs, Food and Drug 

Administration, 12420 Parklawn Drive, 

Rockville, MD 20857, 240–402–8743, 

debarments@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 306(a)(2)(B) of the FD&C Act 

(21 U.S.C. 335a(a)(2)(B)) requires 

debarment of an individual from 

providing services in any capacity to a 

person that has an approved or pending 

drug product application if FDA finds 

that the individual has been convicted 

of a felony under Federal law for 

conduct relating to the regulation of any 

drug product under the FD&C Act. On 

January 13, 2020, Mr. Gurry was 

convicted as defined in section 306(l)(1) 

of the FD&C Act when judgment was 

entered against him in the U.S. District 

Court for the District of Massachusetts, 

after a jury verdict, on one count of 

racketeering conspiracy in violation of 

18 U.S.C. 1962(d). The pattern of 

racketeering activity he was convicted 

of included engaging in multiple acts of 

mail fraud (18 U.S.C. 1341) and wire 

fraud (18 U.S.C. 1343). 

The factual basis for this conviction is 

as follows: Mr. Gurry held executive 

management positions, to include Vice 

President of Managed Markets, of Insys 

Therapeutics Inc. (Insys), a Delaware 

Corporation, with headquarters in 

Chandler, Arizona. Insys developed and 

owned a drug called SUBSYS, a liquid 

formulation of fentanyl to be applied 

under the tongue. FDA approved 

SUBSYS for the management of 

breakthrough pain in adult cancer 

patients who are already receiving and 

are already tolerant to opioid therapy for 

their underlying persistent cancer pain. 

From early 2012 and continuing through 

2015, Mr. Gurry participated in a 

conspiracy whereby employees of Insys 

bribed medical practitioners in various 

states to get those practitioners to 

increase prescribing SUBSYS to their 

patients, many of whom did not have 

cancer. Mr. Gurry, along with his 

coconspirators, measured the effect of 

these bribes on each practitioner’s 

prescribing habits and on the revenue 

that each bribed practitioner generated 

for Insys. Mr. Gurry, along with his 

coconspirators, reduced or eliminated 

bribes paid to those practitioners who 

failed to meet the minimum 

prescription requirements or failed to 

generate enough revenue to justify 

additional bribes. To further this 

conspiracy, Mr. Gurry and his 

coconspirators misled and defrauded 

health insurance providers to ensure 

those providers approved payment for 

SUBSYS. Insys achieved this goal by 

establishing the ‘‘Insys Reimbursement 

Center’’, which was designed to shift the 

burden of seeking prior authorization 

for SUBSYS from practitioners to Insys. 

This allowed Insys to determine what 

medical information was presented to 

insurers. Mr. Gurry and his 

coconspirators directed Insys employees 

to mislead insurers to obtain payment 

authorization. 

As a result of this conviction, FDA 

sent Mr. Gurry, by United Parcel 

Service, on September 21, 2020, a notice 

proposing to permanently debar him 

from providing services in any capacity 

to a person that has an approved or 

pending drug product application. The 

proposal was based on a finding, under 

section 306(a)(2)(B) of the FD&C Act, 

that Mr. Gurry was convicted of a felony 

under Federal law for conduct relating 

to the regulation of a drug product 

under the FD&C Act. The proposal also 

offered Mr. Gurry an opportunity to 

request a hearing, providing him 30 

days from the date of receipt of the letter 

in which to file the request, and advised 

him that failure to request a hearing 

constituted an election not to use the 

opportunity for a hearing and a waiver 

of any contentions concerning this 


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12474 Federal Register / Vol. 86, No. 40 / Wednesday, March 3, 2021 / Notices 

action. Mr. Gurry received the proposal 

on September 22, 2020. He did not 

request a hearing within the timeframe 

prescribed by regulation and has, 

therefore, waived his opportunity for a 

hearing and any contentions concerning 

his debarment (21 CFR part 12). 

II. Findings and Order 

Therefore, the Assistant 

Commissioner, Office of Human and 

Animal Food Operations, under section 

306(a)(2)(B) of the FD&C Act, under 

authority delegated to the Assistant 

Commissioner, finds that Mr. Gurry has 

been convicted of a felony under 

Federal law for conduct otherwise 

relating to the regulation of a drug 

product under the FD&C Act. 

As a result of the foregoing finding, 

Mr. Gurry is permanently debarred from 

providing services in any capacity to a 

person with an approved or pending 

drug product application, effective (see 

DATES) (see sections 306(a)(2)(B) and 

(c)(2)(A)(ii) of the FD&C Act). Any 

person with an approved or pending 

drug product application who 

knowingly employs or retains as a 

consultant or contractor, or otherwise 

uses the services of Mr. Gurry in any 

capacity during his debarment, will be 

subject to civil money penalties (section 

307(a)(6) of the FD&C Act (21 U.S.C. 

335b(a)(6))). If Mr. Gurry provides 

services in any capacity to a person with 

an approved or pending drug product 

application during his period of 

debarment, he will be subject to civil 

money penalties (section 307(a)(7) of the 

FD&C Act). In addition, FDA will not 

accept or review any abbreviated new 

drug application from Mr. Gurry during 

his period of debarment, other than in 

connection with an audit under section 

306 of the FD&C Act (section 

306(c)(1)(B) of the FD&C Act). Note that, 

for purposes of section 306 of the FD&C 

Act, a ‘‘drug product’’ is defined as a 

drug subject to regulation under section 

505, 512, or 802 of the FD&C Act (21 

U.S.C. 355, 360b, or 382) or under 

section 351 of the Public Health Service 

Act (42 U.S.C. 262) (section 201(dd) of 

the FD&C Act (21 U.S.C. 321(dd))). 

Any application by Mr. Gurry for 

special termination of debarment under 

section 306(d)(4) of the FD&C Act 

should be identified with Docket No. 

FDA–2020–N–1413 and sent to the 

Dockets Management Staff (see 

ADDRESSES). The public availability of 

information in these submissions is 

governed by 21 CFR 10.20. 

Publicly available submissions will be 

placed in the docket and will be 

viewable at https://www.regulations.gov 

or at the Dockets Management Staff (see 

ADDRESSES) between 9 a.m. and 4 p.m., 

Monday through Friday, 240–402–7500. 

Dated: February 25, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–04374 Filed 3–2–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0104] 

PolyMedica Industries Inc., et al.; 

Proposal To Withdraw Approval of 

Three New Drug Applications; 

Opportunity for a Hearing 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration’s (FDA or Agency) 

Center for Drug Evaluation and Research 

(CDER) is proposing to withdraw 

approval of three new drug applications 

(NDAs) and is announcing an 

opportunity for the NDA holders to 

request a hearing on this proposal. The 

basis for the proposal is that the NDA 

holders have repeatedly failed to file 

required annual reports for those NDAs. 

DATES: The NDA holders may submit a 

request for a hearing by April 2, 2021. 

Submit all data, information, and 

analyses upon which the request for a 

hearing relies by May 3, 2021. Submit 

electronic or written comments by May 

3, 2021. 

ADDRESSES: The request for a hearing 

may be submitted by the NDA holders 

by either of the following methods: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

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

instructions for submitting comments to 

submit your request for a hearing. 

Comments submitted electronically to 

https://www.regulations.gov, including 

any attachments to the request for a 

hearing, will be posted to the docket 

unchanged. 

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. 

• Because your request for a hearing 

will be made public, you are solely 

responsible for ensuring that your 

request 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. The request 

for a hearing must include the Docket 

No. FDA–2021–N–0104 for 

‘‘PolyMedica Industries Inc. et al.; 

Proposal to Withdraw Approval of 

Three New Drug Applications; 

Opportunity for a Hearing.’’ The request 

for a hearing will be placed in the 

docket and publicly viewable at https:// 

www.regulations.gov or at the Dockets 

Management Staff between 9 a.m. and 4 

p.m., Monday through Friday, 240–402– 

7500. 

The NDA holders may submit all data 

and analyses upon which the request for 

a hearing relies in the same manner as 

the request for a hearing except as 

follows: 

• Confidential Submissions—To 

submit any data analyses with 

confidential information that you do not 

wish to be made publicly available, 

submit your data and analyses only as 

a written/paper submission. You should 

submit two copies total of all data and 

analyses. 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 any decisions on 

this matter. 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 

or available at the Dockets Management 

Staff between 9 a.m. and 4 p.m., 

Monday through Friday, 240–402–7500. 

Submit both copies to the Dockets 

Management Staff. Any information 

marked as ‘‘confidential’’ will not be 

disclosed except in accordance with 21 

CFR 10.20 and other applicable 

disclosure law. 

Comments Submitted by Other 

Interested Parties: For all comments 

submitted by other interested parties, 

submit comments as follows: 

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:// 


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