Document ID: FDA-2022-N-0736-0002
Agency: fda
Document Type: Notice
Title: Gregory Settino: Final Debarment Order
Posted Date: 2022-10-18T04:00Z

[Federal Register Volume 87, Number 200 (Tuesday, October 18, 2022)]
[Notices]
[Page 63076]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-22613]

[[Page 63076]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-0736]

Gregory Settino: Final Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is issuing an order 
under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently 
debarring Gregory Settino 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. Settino was convicted of a 
felony under Federal law for conduct that relates to the regulation of 
any drug product under the FD&C Act. Mr. Settino 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 August 
15, 2022 (30 days after receipt of the notice), Mr. Settino had not 
responded. Mr. Settino's failure to respond and request a hearing 
within the prescribed timeframe constitutes a waiver of his right to a 
hearing concerning this action.

DATES: This order is applicable October 18, 2022.

ADDRESSES: Submit applications for special 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, Division of 
Enforcement (ELEM-4144), Office of Strategic Planning and Operational 
Policy, Office of Regulatory Affairs, Food and Drug Administration, 
12420 Parklawn Dr., Rockville, MD 20857, 240-402-8743, or at 
[email protected].

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 April 20, 2022, Mr. Settino was 
convicted, as defined in section 306(l)(1) of the FD&C Act, in the U.S. 
District Court for the Eastern District of New York, when the court 
accepted his plea of guilty and entered judgment against him for the 
felony offense of theft of medical products in violation of 18 U.S.C. 
670.
    As described in the indictment in his case, filed on September 20, 
2020, from approximately 2012 to January 2020, Mr. Settino was the 
production supervisor of manufacturing for Luitpold Pharmaceuticals, 
Inc. (Luitpold), which was renamed American Regent, Inc. (American 
Regent) in January 2019. Luitpold and American Regent manufactured an 
injectable equine drug called ADEQUAN, which is administered to horses 
with degenerative joint disease. In his capacity as a production 
supervisor, Mr. Settino supervised the manufacture of pre-retail 
medical products including ADEQUAN. From approximately 2012 to January 
2020, Mr. Settino stole thousands of bottles of ADEQUAN from Luitpold 
and American Regent and then sold the stolen ADEQUAN for a total of 
more than $600,000. As contained in the sentencing memoranda from his 
case, filed on March 31, 2022, and April 19, 2022, Mr. Settino resold 
the stolen drugs, many of which were expired, to horse trainers and 
veterinarians at New York area racetracks.
    Based on this conviction, FDA sent Mr. Settino by certified mail on 
July 11, 2022, 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. Settino was 
convicted, as set forth in section 306(l)(1) of the FD&C Act, of a 
felony under Federal law for conduct relating to the regulation of any 
drug product under the FD&C Act. The proposal also offered Mr. Settino 
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. Settino received the proposal on July 15, 
2022. 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. 
Settino has been convicted of a felony under Federal law for conduct 
relating to the regulation of any drug product under the FD&C Act.
    As a result of the foregoing finding, Mr. Settino is permanently 
debarred from providing services in any capacity to a person with an 
approved or pending drug product application, applicable (see DATES) 
(see section 306(a)(2)(B) and 306(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 in any capacity the services of Mr. Settino 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. Settino 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. Settino 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 sections 306 
and 307 of the FD&C Act, a ``drug product'' is defined as a ``drug 
subject to regulation under section 505, 512, or 802 of this Act (21 
U.S.C. 355, 360b, 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. Settino for special termination of debarment 
under section 306(d)(4) of the FD&C Act should be identified with 
Docket No. FDA-2022-N-0736 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: October 13, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-22613 Filed 10-17-22; 8:45 am]
BILLING CODE 4164-01-P