Notice2022-22613
Gregory Settino: Final Debarment Order
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
October 18, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 200 (Tuesday, October 18, 2022)</title>
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[Federal Register Volume 87, Number 200 (Tuesday, October 18, 2022)]
[Notices]
[Page 63076]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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
<a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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
<a href="/cdn-cgi/l/email-protection#096d6c6b687b646c677d7a496f6d682761617a276e667f"><span class="__cf_email__" data-cfemail="a0c4c5c2c1d2cdc5ced4d3e0c6c4c18ec8c8d38ec7cfd6">[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 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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
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