[Federal Register Volume 85, Number 224 (Thursday, November 19, 2020)]
[Notices]
[Pages 73726-73727]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-25601]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1394]


Richard M. Simon: Final Debarment Order

AGENCY: Food and Drug Administration, HHS.

[[Page 73727]]


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 Richard M. Simon 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 Richard M. Simon 
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. Simon 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. Simon had not 
responded. Mr. Simon'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 19, 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.

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, [email protected], or at 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 21, 2020, Mr. Simon 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. Simon held 
executive management positions, including Regional Sales Manager for 
the Southeast Region and Vice President of Sales, 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. Simon 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. Simon, along with his 
co-conspirators, measured the effect of these bribes on each 
practitioner's prescribing habits and on the revenue that each bribed 
practitioner generated for Insys. Mr. Simon, along with his co-
conspirators, 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.
    As a result of this conviction, FDA sent Mr. Simon by certified 
mail on August 3, 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. Simon 
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. Simon 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. Simon received the proposal 
on August 7, 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. Simon 
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. Simon, 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. Simon, 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. Simon 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. 
Simon during his period of debarment, other than in connection with an 
audit under 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. Simon for special termination of debarment 
under section 306(d)(4) of the FD&C Act should be identified with 
Docket No. FDA-2020-N-1394 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 16, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-25601 Filed 11-18-20; 8:45 am]
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