[Federal Register Volume 86, Number 40 (Wednesday, March 3, 2021)]
[Notices]
[Pages 12473-12474]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-04374]


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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.

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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 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, 
<a href="/cdn-cgi/l/email-protection#c2a6a7a0a3b0afa7acb6b182a4a6a3ecaaaab1eca5adb4"><span class="__cf_email__" data-cfemail="492d2c2b283b242c273d3a092f2d286721213a672e263f">[email protected]</span></a>.

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

[[Page 12474]]

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


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