Notice2024-05981
Willis Reed: 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
March 21, 2024
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 Willis Reed 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. Reed 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. Reed was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of February 10, 2024 (30 days after receipt of the notice), Mr. Reed has not responded. Mr. Reed's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.
Full Text
<html>
<head>
<title>Federal Register, Volume 89 Issue 56 (Thursday, March 21, 2024)</title>
</head>
<body><pre>
[Federal Register Volume 89, Number 56 (Thursday, March 21, 2024)]
[Notices]
[Pages 20205-20207]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-05981]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-4721]
Willis Reed: Final Debarment Order
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is issuing an order
under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently
debarring Willis Reed from providing services in any capacity to a
person that has an approved or pending drug product application. FDA
bases this
[[Page 20206]]
order on a finding that Mr. Reed 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. Reed was given notice of the proposed
debarment and an opportunity to request a hearing within the timeframe
prescribed by regulation. As of February 10, 2024 (30 days after
receipt of the notice), Mr. Reed has not responded. Mr. Reed's failure
to respond and request a hearing constitutes a waiver of his right to a
hearing concerning this matter.
DATES: This order is applicable March 21, 2024.
ADDRESSES: Any application by Mr. Reed for special termination of
debarment under section 306(d)(4) of the FD&C Act (21 U.S.C.
335a(d)(4)) may be submitted at any time as follows:
Electronic Submissions
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. An application
submitted electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a> will be posted to the docket unchanged. Because
your application will be made public, you are solely responsible for
ensuring that your application does not include any confidential
information that you or a third party may not wish to be posted, such
as medical information, your or anyone else's Social Security number,
or confidential business information, such as a manufacturing process.
Please note that if you include your name, contact information, or
other information that identifies you in the body of your application,
that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit an application with confidential
information that you do not wish to be made available to the public,
submit the application as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For a written/paper application submitted to the Dockets
Management Staff, FDA will post your application, as well as any
attachments, except for information submitted, marked, and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All applications must include the Docket No. FDA-
2023-N-4721. Received applications will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit an application with
confidential information that you do not wish to be made publicly
available, submit your application only as a written/paper submission.
You should submit two copies total. One copy will include the
information you claim to be confidential with a heading or cover note
that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The
Agency will review this copy, including the claimed confidential
information, in its consideration of your application. The second copy,
which will have the claimed confidential information redacted/blacked
out, will be available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Submit both copies to the Dockets Management
Staff. 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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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, between 9 a.m. and 4 p.m., Monday through Friday, 240-402-
7500. Publicly available submissions may be seen in the docket.
FOR FURTHER INFORMATION CONTACT: Jaime Espinosa, Division of Compliance
and Enforcement, Office of Policy, Compliance, and Enforcement, Office
of Regulatory Affairs, Food and Drug Administration, at 240-402-8743,
or <a href="/cdn-cgi/l/email-protection#90f4f5f2f1e2fdf5fee4e3d0f6f4f1bef8f8e3bef7ffe6"><span class="__cf_email__" data-cfemail="b8dcdddad9cad5ddd6cccbf8dedcd996d0d0cb96dfd7ce">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(a)(2)(B) of the FD&C Act 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 October 12, 2023, Mr. Reed 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 Texas-Beaumont Division, when the court entered judgment
against him after his plea of guilty of conspiracy to traffick in drugs
with counterfeit mark in violation of 18 U.S.C. 371 and 18 U.S.C.
2320(a)(4). The underlying facts supporting the conviction are as
follows: As contained in the Second Superseding Indictment, and as
contained in Factual Basis, from approximately April 2015 until January
2019, Mr. Reed conspired with drug traffickers to distribute misbranded
and counterfeit cough syrup. Specifically, he worked for Woodfield
Pharmaceutical LLC, as its Production Manager, and later, he was
promoted to Director of Technical Operations. Woodfield Pharmaceutical
LLC was part of a group of pharmaceutical companies that included
Woodfield Pharmaceutical LLC, a contract manufacturing company, and
Woodfield Distribution LLC, a third-party logistics company
(collectively, Woodfield).
On April 25, 2014, Woodfield acquired Pernix Manufacturing LLC
(Pernix). Pernix had in January 2014, entered into an agreement with
Byron A. Marshall and his drug trafficking organization (DTO) to copy
and manufacture cough syrup according to the directions of Marshall and
his associates. Marshall was not licensed or authorized to distribute
cough syrup and any background check of the personal information
provided by Marshall to Pernix or later Woodfield would have revealed
that he was not a licensed physician as he claimed. Initially, Marshall
sought to copy Actavis Prometh VC with Codeine (Actavis). Actavis is a
purple, peach-mint flavor prescription cough syrup that was in demand
as a street drug. Marshall and his associates wanted to mass produce
and traffic a counterfeit version of Actavis that contained
promethazine, but not codeine. Cough syrups containing promethazine or
codeine were approved by FDA for distribution only under the
supervision of a licensed practitioner.
On April 24, 2014, Actavis Holdco U.S. discontinued production of
Actavis due to its widespread abuse by recreational drug users. A
Pernix product-development scientist worked with Marshall and his
associates to recreate the Actavis product without codeine and
promethazine to recreate the syrup base, which is a necessary component
of cough syrup. Marshall and his associates would add promethazine to
the counterfeit
[[Page 20207]]
substance prior to bottling and distribution to create the street drug.
Marshall and his DTO also obtained counterfeited commercial-grade
pharmaceutical labels designed to look exactly like the genuine labels
for the prescription cough syrup from another supplier.
In his role with Woodfield, Mr. Reed knew that the Marshall DTO was
adding active ingredients to the syrup Woodfield sold to the Marshall
DTO. From approximately April 2015 until January 2019, Mr. Reed was
principally responsible for the large-scale production of syrup base
for the Marshall DTO. Beginning on or about May 26, 2015, Mr. Reed
became the Marshall DTO's principal source of supply for promethazine.
Mr. Reed brokered the promethazine from a lab chemical supplier based
in New York that delivered the promethazine directly to the Marshall
DTO. In January 2019 Mr. Reed was fired from his position at Woodfield.
As a result of this conviction, FDA sent Mr. Reed, by certified
mail, on January 5, 2024, 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), that Mr. Reed 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 informed Mr. Reed of the
proposed debarment and offered him 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 a waiver of the opportunity for a hearing and of any
contentions concerning this action. Mr. Reed received the proposal and
notice of opportunity for a hearing on January 11, 2024. Mr. Reed
failed to request a hearing within the timeframe prescribed by
regulation and has, therefore, waived his opportunity for a hearing and
waived 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.
Willis Reed has been convicted of a felony under Federal law for
conduct relating to the regulation of a drug product under the FD&C
Act.
As a result of the foregoing finding, Mr. Reed is permanently
debarred from providing services in any capacity to a person with an
approved or pending drug product application, effective (see DATES)
(see sections 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. Reed 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. Reed 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.
Reed 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 (21 U.S.C. 335a(c)(1)(B))). 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
FD&C 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))).
Dated: March 15, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-05981 Filed 3-20-24; 8:45 am]
BILLING CODE 4164-01-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on March 21, 2024.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.