[Federal Register Volume 89, Number 56 (Thursday, March 21, 2024)]
[Notices]
[Pages 20205-20207]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-05981]


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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.

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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 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

     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. An application 
submitted electronically, including attachments, to https://www.regulations.gov 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 https://www.regulations.gov.
     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

     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.
     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 https://www.regulations.gov or at the Dockets Management 
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
     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 https://www.regulations.gov. 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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket, 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, 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 [email protected].

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