[Federal Register Volume 86, Number 1 (Monday, January 4, 2021)]
[Notices]
[Pages 102-103]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-29046]


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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.

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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, [email protected], 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

[[Page 103]]

whom they wrote the additional SUBSYS prescriptions did not have 
cancer. Mr. Burlakoff, along with his co-conspirators, 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]
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