Richard M. Simon: Final Debarment Order
| Citation | 85 FR 73726 |
| Record Number | 2020-25601 |
| Published date | 19 November 2020 |
| Section | Notices |
| Court | Food And Drug Administration |
Federal Register, Volume 85 Issue 224 (Thursday, November 19, 2020)
[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]
BILLING CODE 4164-01-P
