76582 Federal Register / Vol. 85, No. 230 / Monday, November 30, 2020 / Notices 

Chief Executive Officer (CEO). 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 2012 and 

continuing through 2015, Mr. Kapoor 

oversaw a conspiracy whereby 

employees of Insys bribed medical 

practitioners in various states to get 

those practitioners to increase 

prescribing SUBSYS to their patients. 

Mr. Kapoor, 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. Kapoor, 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. 

Kapoor oversaw a scheme whereby 

Insys executives conspired to mislead 

and defraud 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. Kapoor and his co-conspirators 

directed Insys employees to mislead 

insurers to obtain payment 

authorization. 

As a result of this conviction, FDA 

sent Mr. Kapoor by certified mail on 

July 16, 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. 

Kapoor 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. 

Kapoor 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 action. Mr. 

Kapoor received the proposal on July 

27, 2020. Mr. Kapoor, through counsel, 

submitted a letter to FDA dated August 

12, 2020, which commented on some of 

the factual circumstances surrounding 

the case. In the letter, he also stated that 

he did not intend to request a hearing 

nor, however, would he acquiesce to 

debarment. Since he did not request a 

hearing within the timeframe prescribed 

by regulation, Mr. Kapoor has 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. Kapoor 

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. Kapoor, 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. Kapoor, 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. Kapoor 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. Kapoor 

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) (see section 201(dd) 

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

Any application by Mr. Kapoor for 

special termination of debarment under 

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

should be identified with Docket No. 

FDA–2020–N–1337 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: November 23, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–26262 Filed 11–27–20; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–N–4248] 

Barry J. Cadden: 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 Barry J. 

Cadden 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. Cadden 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. 

Cadden 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 

July 9, 2020 (30 days after receipt of the 

notice), Mr. Cadden had not responded. 

Mr. Cadden’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 

November 30, 2020. 

ADDRESSES: Submit applications for 

special termination of debarment to the 

Dockets Management Staff (HFA–305), 

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, Division of 

Enforcement, Office of Strategic 

Planning and Operational Policy, Office 

of Regulatory Affairs, Food and Drug 

Administration, 12420 Parklawn Dr., 

Rockville, MD 20857, debarments@

fda.hhs.gov, or at 240–402–8743. 

SUPPLEMENTARY INFORMATION: 


TKELLEY on DSKBCP9HB2PROD with NOTICES
Federal Register / Vol. 85, No. 230 / Monday, November 30, 2020 / Notices 76583 

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 

June 27, 2017, Mr. Cadden 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, for one count of 

racketeering in violation of 18 U.S.C. 

1962(c), one count of racketeering 

conspiracy in violation of 18 U.S.C. 

1962(d), 52 counts of mail fraud in 

violation of 18 U.S.C. 1341, and three 

counts of introduction of misbranded 

drugs into interstate commerce with the 

intent to defraud and mislead-no 

prescriptions in violation of 21 U.S.C. 

353(b)(1), 331(a), and 333(a)(2). 

As contained in counts 1–2, 4–39, 41– 

56, 95, and 99–100 of the indictment, 

filed on December 16, 2014, Mr. Cadden 

was an owner and director of the New 

England Compounding Center (NECC), 

which held itself out as a compoundingonly pharmacy, and he served as 

NECC’s president, head pharmacist, and 

Manager of Record. In addition, Mr. 

Cadden was an owner and director of 

Medical Sales Management, Inc. (MSM), 

and served as MSM’s Treasurer. MSM 

provided sales and administrative 

services to NECC for which MSM was 

paid a service fee. MSM’s sales 

representatives sold drugs on behalf of 

NECC to customers throughout the 

country. In those capacities, Mr. Cadden 

instructed the MSM sales force to falsely 

represent to customers that NECC was 

providing the highest quality 

compounded medications, when in fact 

Mr. Cadden, among other things, failed 

to properly sterilize drug products 

consistent with applicable U.S. 

Pharmacopeia standards, failed to test 

purportedly sterile drugs, authorized the 

shipping of drugs before test results 

confirming their sterility were returned, 

never notified customers of nonsterile 

results, and compounded drugs with 

expired ingredients. Additionally, Mr. 

Cadden directed and authorized the 

shipping and mailing, in interstate 

commerce, of contaminated 

methylprednisolone acetate to NECC 

customers nationwide. Mr. Cadden also 

caused drugs to be introduced and 

delivered into interstate commerce 

without the valid prescription of a 

practitioner licensed by law to 

administer drugs, which act resulted in 

the drugs being misbranded. Further, 

Mr. Cadden defrauded the United States 

by interfering with and obstructing the 

lawful governmental functions of FDA 

by claiming to be a pharmacy 

dispensing drugs pursuant to valid, 

patient-specific prescriptions. In fact, 

NECC routinely dispensed drugs in bulk 

without valid, patient-specific 

prescriptions. 

As a result of this conviction, FDA 

sent Mr. Cadden, by certified mail on 

June 2, 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. 

Cadden was convicted of felonies under 

Federal law for conduct relating to the 

regulation of a drug product under the 

FD&C Act. The proposal also offered Mr. 

Cadden 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 action. Mr. 

Cadden received the proposal on June 9, 

2020. Mr. Cadden 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 Barry J. 

Cadden, 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, 

Barry J. Cadden, 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 306(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 Barry J. 

Cadden, 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. 

Cadden 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 applications 

from Mr. Cadden 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, 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. Cadden for 

special termination of debarment under 

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

should be identified with Docket No. 

FDA–2019–N–4248 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 

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

through Friday, 240–402–7500. 

Dated: November 23, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–26255 Filed 11–27–20; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–1255] 

Tuan Anh Tran: Final Debarment Order 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is issuing an 

order under the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) debarring 

Tuan Anh Tran for a period of 5 years 

from importing or offering for import 

any drug into the United States. FDA 

bases this order on a finding that Mr. 

Tran engaged in a pattern of importing 

or offering for import misbranded drugs 

(i.e., in an amount, frequency, or dosage 

that is inconsistent with his personal or 

household use) that are not designated 

in an authorized electronic data 

interchange system as products 


TKELLEY on DSKBCP9HB2PROD with NOTICES