Notice2024-09917
Adam Paul Runsdorf: 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
May 7, 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 Adam Paul Runsdorf 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. Runsdorf 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. Runsdorf was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of February 25, 2024 (30 days after receipt of the notice), Mr. Runsdorf has not responded. Mr. Runsdorf's failure to respond and request a hearing constitutes a waiver of Mr. Runsdorf's right to a hearing concerning this matter.
Full Text
<html>
<head>
<title>Federal Register, Volume 89 Issue 89 (Tuesday, May 7, 2024)</title>
</head>
<body><pre>
[Federal Register Volume 89, Number 89 (Tuesday, May 7, 2024)]
[Notices]
[Pages 38159-38161]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-09917]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-3827]
Adam Paul Runsdorf: 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 Adam Paul Runsdorf 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. Runsdorf 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. Runsdorf was given notice of the
proposed debarment and an opportunity to request a hearing within the
timeframe prescribed by regulation. As of February 25, 2024 (30 days
after receipt of the notice), Mr. Runsdorf has not responded. Mr.
Runsdorf's failure to respond and request a hearing constitutes a
waiver of Mr. Runsdorf's right to a hearing concerning this matter.
DATES: This order is applicable May 7, 2024.
ADDRESSES: Any application by Mr. Runsdorf 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
[[Page 38160]]
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-3827. 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#82e6e7e0e3f0efe7ecf6f1c2e4e6e3aceaeaf1ace5edf4"><span class="__cf_email__" data-cfemail="c8acadaaa9baa5ada6bcbb88aeaca9e6a0a0bbe6afa7be">[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
July 27, 2023, Adam Paul Runsdorf 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, to Conspiracy to Traffick in
Drugs with Counterfeit Mark in violation of 18 U.S.C. 371, 18 U.S.C.
2320(a)(4) and Trafficking in Drugs with Counterfeit Mark in violation
of 18 U.S.C. 2320(a)(4), 18 U.S.C. 2320(b)(3)(A). The underlying facts
supporting the conviction are as follows:
As contained in the Third Superseding Indictment, and as contained
in Factual Basis and Stipulation memorandum, between approximately
April 2014 and February 2021, Mr. Runsdorf conspired to distribute
counterfeit cough syrup. Specifically, Mr. Runsdorf owned a group of
pharmaceutical companies including Woodfield Pharmaceutical LLC, a
contract manufacturing company, and Woodfield Distribution LLC, a
third-party logistics company (collectively, ``Woodfield''). On April
25, 2014, Mr. Runsdorf 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. 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. On April 24, 2014, Actavis Holdco US discontinued production
of the Actavis product due to its widespread abuse by recreational drug
users. A Pernix product-development scientist worked with Marshall and
his associates to re-create the Actavis product without Codeine and
Promethazine in order to re-create 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. Later in the conspiracy, Marshall and his
DTO asked Woodfield employees to reformulate other cough syrup to use
in their drug trafficking scheme to include Hi-Tech Promethazine
Hydrocholoride and Codeine Phosphate Oral Solution and Wockhardt
Promethazine Syrup Plain.
As Pernix was scaling-up production of the syrup base for Marshall
and his DTO in April 2014, Mr. Runsdorf acquired Pernix. Mr. Runsdorf
retained Pernix employees but made changes to management staff who
oversaw and were responsible for producing the syrup base for the
Marshall DTO, to which they knew the Marshall DTO was adding active
ingredients. During the conspiracy, Marshall communicated directly with
Mr. Runsdorf regarding production of the counterfeit cough syrup. At
Mr. Runsdorf's request, Marshall paid Woodfield in cash only, and
Woodfield employees mailed the cash directly to him.
Mr. Runsdorf knew his company was producing thousands of gallons of
the counterfeit cough syrup to be distributed to drug traffickers in
Texas and other States. Woodfield's production of syrup base for
Marshall and his DTO bypassed the protocols for safety and quality
testing. Initially, there were no batch records to document the
[[Page 38161]]
production of the syrup as required. Woodfield provided the syrup to
Marshall and his DTO without any corresponding documentation that
identified the ingredients of the syrup; practices that continued until
February 2019 when Woodfield started creating paper records for some of
the cough syrup batches Woodfield made for the DTO. 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. The total amount of cash
paid by Marshall and his DTO to Mr. Runsdorf was approximately at least
$3 million.
As a result of this conviction, FDA sent Mr. Runsdorf, by certified
mail, on January 23, 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. Runsdorf was convicted
of two felonies under Federal law for conduct relating to the
regulation of a drug product under the FD&C Act. The proposal informed
Mr. Runsdorf 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. Runsdorf
received the proposal and notice of opportunity for a hearing on
January 26, 2024. Mr. Runsdorf 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.
Runsdorf 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. Runsdorf 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. Runsdorf 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. Runsdorf 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. Runsdorf 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
FD&C Act [(21 U.S.C. 355, 360b, or 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: May 2, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-09917 Filed 5-6-24; 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 May 7, 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.