Notice2024-12975
Jonathan R. Shaver: Final Debarment Order
Primary source
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Published
June 13, 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 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.
Full Text
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<title>Federal Register, Volume 89 Issue 115 (Thursday, June 13, 2024)</title>
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[Federal Register Volume 89, Number 115 (Thursday, June 13, 2024)]
[Notices]
[Pages 50343-50344]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-12975]
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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.
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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 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
<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-4466. 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, 240-402-8743,
<a href="/cdn-cgi/l/email-protection#7014151211021d151e0403301614115e1818035e171f06"><span class="__cf_email__" data-cfemail="0b6f6e696a79666e657f784b6d6f6a25636378256c647d">[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
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
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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
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