102 Federal Register / Vol. 86, No. 1 / Monday, January 4, 2021 / Notices 

Smith received the proposal on August 

28, 2020. Mr. Smith 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. Smith has 

been convicted of multiple felonies 

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. Smith is permanently debarred from 

providing services in any capacity to a 

person with an approved or pending 

drug product application, effective (see 

DATES) (see section 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. Smith, 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. Smith 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. Smith 

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. Smith for 

special termination of debarment under 

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

should be identified with Docket No. 

FDA–2019–N–3794 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: December 28, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–29052 Filed 12–31–20; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–1372] 

Alec Burlakoff: 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 Alec 

Burlakoff 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 Alec Burlakoff 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. Burlakoff was given notice of the 

proposed permanent debarment and 

was given an opportunity to request a 

hearing to show why he should not be 

debarred. As of July 24, 2020 (30 days 

after receipt of the notice), Mr. Burlakoff 

had not responded. Mr. Burlakoff’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 January 

4, 2021. 

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. 

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, 240–402–8743. 

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 23, 2020, Mr. Burlakoff 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 his plea of guilty, to 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 

illegal distribution of a controlled 

substance (21 U.S.C. 841(a)(1)); mail 

fraud (18 U.S.C. 1341); wire fraud (18 

U.S.C. 1343); honest services mail fraud 

(18 U.S.C. 1341 and 1346); and, honest 

services wire fraud (18 U.S.C. 1343 and 

1346). 

The factual basis for this conviction is 

as follows: Mr. Burlakoff held executive 

management positions at Insys 

Therapeutics Inc. (Insys), including 

Regional Sales Manager for the 

Southeast Region and Vice President of 

Sales. Insys is 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 May 2012 

and continuing until December 2015, he 

participated in a conspiracy whereby 

employees of Insys bribed and provided 

kickbacks to medical practitioners in 

various states to get those practitioners 

to increase prescribing SUBSYS to their 

patients, many of whom did not have 

cancer. The bribes and kickbacks took 

various forms to include honoraria for 

the practitioners’ participation in 

educational events, payment of the 

practitioner’s staff salaries, and the 

completion of office tasks for the 

provider performed by Insys employees. 

Mr. Burlakoff and his co-conspirators 

used pharmacy data acquired from third 

parties to identify practitioners who 

either prescribed unusually high 

volumes of rapid-onset opioids, or had 

demonstrated a capacity to prescribe 

unusually large volumes of rapid-onset 

opioids. In exchange for bribes and 

kickbacks to these targeted practitioners, 

the practitioners increased the number 

of new SUBSYS prescriptions they 

wrote and increased the dosage and 

number of units of SUBSYS for new and 

existing prescriptions. Many of the 

targeted practitioner’s patients for 

Federal Register / Vol. 86, No. 1 / Monday, January 4, 2021 / Notices 103 

whom they wrote the additional 

SUBSYS prescriptions did not have 

cancer. Mr. Burlakoff, along with his coconspirators, measured the effect of the 

bribes and kickbacks on each 

practitioner’s prescribing habits and on 

the revenue that each bribed 

practitioner generated. Mr. Burlakoff, 

along with his co-conspirators, reduced 

or eliminated bribes and kickbacks paid 

to those practitioners who failed to meet 

the minimum prescription requirements 

or failed to generate enough revenue to 

justify additional bribes and kickbacks. 

As a result of this conviction, FDA 

sent Mr. Burlakoff 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. 

Burlakoff 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. Burlakoff 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. Burlakoff received the 

proposal on July 25, 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 Alec Burlakoff 

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. Burlakoff, 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. Burlakoff, 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. Burlakoff 

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. Burlakoff 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 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. Burlakoff for 

special termination of debarment under 

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

should be identified with Docket No. 

FDA–2020–N–1372 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: December 28, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–29046 Filed 12–31–20; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–1412] 

Joseph A. Rowan: 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 Joseph A. 

Rowan 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 Joseph A. Rowan 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. Rowan 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 

August 6, 2020 (30 days after receipt of 

the notice), Mr. Rowan had not 

responded. Mr. Rowan’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 January 

4, 2021. 

ADDRESSES: Submit applications for 

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 (ELEM–4029), Division 

of Enforcement, Office of Strategic 

Planning and Operational Policy, Office 

of Regulatory Affairs, Food and Drug 

Administration, 12420 Parklawn Dr., 

Rockville, MD 20857, 240–402–8743, or 

at 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 21, 2020, Mr. Rowan 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. Rowan held executive 

management positions, including 

Regional Sales Manager and Regional 

Director of the East Region 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