[Federal Register Volume 89, Number 115 (Thursday, June 13, 2024)]
[Notices]
[Pages 50343-50344]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-12975]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-4466]


Jonathan R. Shaver: 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 Jonathan R. Shaver 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. Shaver 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. Shaver was given notice of the proposed 
debarment and an opportunity to request a hearing within the timeframe 
prescribed by regulation. As of February 16, 2024 (30 days after 
receipt of the notice), Mr. Shaver has not responded. Mr. Shaver's 
failure to respond and request a hearing constitutes a waiver of Mr. 
Shaver's right to a hearing concerning this matter.

DATES: This order is applicable June 13, 2024.

ADDRESSES: Any application by Mr. Shaver 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-4466. 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, 240-402-8743, 
[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 
September 19, 2023, Mr. Shaver 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 accepted his plea of 
guilty and entered judgment against him for the offense 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 and Stipulation memorandum, between April 2015 and 
January 2019, Mr. Shaver conspired to distribute misbranded and 
counterfeit cough syrup. Mr. Shaver worked for Woodfield Pharmaceutical 
LLC, within its manufacturing and operations division and then later as 
Production Manager. Woodfield Pharmaceutical LLC was a part of a group 
of pharmaceutical companies which 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). In January 
2014, Pernix 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

[[Page 50344]]

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. 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 and codeine were approved by FDA for 
distribution only under the supervision of a licensed practitioner. On 
April 24, 2014, Actavis Holdco US 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 in 
order to recreate the syrup base, which is a necessary component of 
cough syrup. Marshall and his associates would add promethazine to the 
counterfeit substance prior to bottling and distribution in order to 
create the 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 position within Woodfield, Mr. Shaver assisted in the 
production of the syrup. In his role with Woodfield, Mr. Shaver 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. Shaver along with Woodfield's Director of Technical 
Operations were principally responsible for the large-scale production 
of syrup base for the Marshall DTO. When Marshall and his DTO had 
difficulty dissolving promethazine into the syrup base, Mr. Shaver, 
along with others, worked to resolve that issue. Later, Mr. Shaver 
agreed with other Woodfield employees to create additional syrup base 
supply not authorized by Woodfield in order to sell that additional 
supply to the Marshall DTO at a reduced price in order to split the fee 
from the sale with other Woodfield employees, a practice Mr. Shaver and 
other employees called ``double batching.'' No records of the ``double 
batching'' were created by Mr. Shaver or any of the other participants. 
Later in the conspiracy, upon request from Marshall and his DTO, 
Woodfield employees reformulated other cough syrup for use by Marshall 
and his DTO in their drug trafficking scheme to include Hi-Tech 
Promethazine Hydrocholoride and Codeine Phosphate Oral Solution and 
Wockhardt Promethazine Syrup Plain. From 2014 through February 2021, 
the conspiracy between the Marshall DTO produced and distributed, or 
attempted to produce and distribute, approximately 65,920 gallons of 
counterfeit cough syrup.
    As a result of this conviction, FDA sent Mr. Shaver, 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) of the FD&C Act, that Mr. Shaver 
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. Shaver 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. Shaver 
received the proposal and notice of opportunity for a hearing on 
January 17, 2024. Mr. Shaver 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. 
Jonathan R. Shaver 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. Shaver 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. Shaver 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. Shaver 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. Shaver 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 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: June 10, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-12975 Filed 6-12-24; 8:45 am]
BILLING CODE 4164-01-P