Richard M. Simon: Final Debarment Order, 73726-73727 [2020-25601]

Download as PDF 73726 Federal Register / Vol. 85, No. 224 / Thursday, November 19, 2020 / Notices information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https:// www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240–402–7500. 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Background In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a guidance for industry entitled ‘‘Bioequivalence Recommendations for Specific Products’’ that explained the process that would be used to make productspecific guidances available to the public on FDA’s website at https:// www.fda.gov/Drugs/ GuidanceCompliance RegulatoryInformation/Guidances/ default.htm. As described in that guidance, FDA adopted this process as a means to develop and disseminate productspecific guidances and provide a meaningful opportunity for the public to consider and comment on those guidances. Under that process, draft VerDate Sep<11>2014 19:40 Nov 18, 2020 Jkt 253001 guidances are posted on FDA’s website and announced periodically in the Federal Register. The public is encouraged to submit comments on those recommendations within 60 days of their announcement in the Federal Register. FDA considers any comments received and either publishes final guidances or publishes revised draft guidances for comment. Guidances were last announced in the Federal Register on August 26, 2020. This notice announces draft product-specific guidances, either new or revised, that are posted on FDA’s website. TABLE 2—REVISED DRAFT PRODUCTSPECIFIC GUIDANCES FOR DRUG PRODUCTS—Continued Active ingredient(s) Fluphenazine hydrochloride Hydrocortisone acetate Isotretinoin (multiple referenced listed drugs) Levorphanol tartrate Lomitapide mesylate Methylphenidate hydrochloride Pimavanserin tartrate Propranolol hydrochloride (multiple referenced listed drugs) Tofacitinib citrate II. Drug Products For Which New Draft Product-Specific Guidances Are Available FDA is announcing the availability of new draft product-specific guidances for industry for drug products containing the following active ingredients: For a complete history of previously published Federal Register notices related to product-specific guidances, go to https://www.regulations.gov and enter Docket No. FDA–2007–D–0369. These draft guidances are being issued consistent with FDA’s good guidance practices regulation (21 CFR TABLE 1—NEW DRAFT PRODUCT-SPE- 10.115). These draft guidances, when CIFIC GUIDANCES FOR DRUG PROD- finalized, will represent the current thinking of FDA on, among other things, UCTS the product-specific design of BE studies to support ANDAs. They do not Active ingredient(s) establish any rights for any person and Ceritinib are not binding on FDA or the public. Clobazam You can use an alternative approach if Crofelemer it satisfies the requirements of the Diazepam applicable statutes and regulations. Epinephrine Fluorodopa F–18 Lefamulin acetate Naloxone hydrochloride; Oxycodone hydrochloride Pretomanid Prochlorperazine maleate Tafamidis Tafamidis meglumine Vancomycin hydrochloride III. Drug Products For Which Revised Draft Product-Specific Guidances Are Available FDA is announcing the availability of revised draft product-specific guidances for industry for drug products containing the following active ingredients: TABLE 2—REVISED DRAFT PRODUCTSPECIFIC GUIDANCES FOR DRUG PRODUCTS IV. Paperwork Reduction Act of 1995 FDA tentatively concludes that this draft guidance contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required. V. Electronic Access Persons with access to the internet may obtain the draft guidances at either https://www.fda.gov/drugs/guidancecompliance-regulatory-information/ guidances-drugs or https:// www.regulations.gov. Dated: November 13, 2020. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2020–25602 Filed 11–18–20; 8:45 am] BILLING CODE 4164–01–P Active ingredient(s) Azelaic acid Budesonide Bupropion hydrochloride; Naltrexone hydrochloride Calcipotriene Clobetasol propionate Desonide Erythromycin ethylsuccinate (multiple referenced listed drugs) Erythromycin ethylsuccinate; Sulfisoxazole acetyl PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 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. E:\FR\FM\19NON1.SGM 19NON1 Federal Register / Vol. 85, No. 224 / Thursday, November 19, 2020 / Notices ACTION: Notice. 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, debarments@ fda.hhs.gov, or at 240–402–8743. SUPPLEMENTARY INFORMATION: SUMMARY: 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 VerDate Sep<11>2014 19:40 Nov 18, 2020 Jkt 253001 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 PO 00000 Frm 00058 Fmt 4703 Sfmt 9990 73727 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 E:\FR\FM\19NON1.SGM 19NON1

Agencies

[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.

-----------------------------------------------------------------------

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

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