Notice2023-17784
David Winne; Denial of Hearing; 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
August 18, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is denying a request for a hearing submitted by David Roy Winne (Winne) and is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Winne 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 Winne was convicted of multiple felonies under Federal law for conduct relating to the regulation of a drug product under the FD&C Act. Winne was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Winne submitted a request for hearing but failed to file with the Agency information and analysis sufficient to create a basis for a hearing.
Full Text
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<title>Federal Register, Volume 88 Issue 159 (Friday, August 18, 2023)</title>
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[Federal Register Volume 88, Number 159 (Friday, August 18, 2023)]
[Notices]
[Pages 56636-56637]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-17784]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-2558]
David Winne; Denial of Hearing; Final Debarment Order
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is denying a
request for a hearing submitted by David Roy Winne (Winne) and is
issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C
Act) permanently debarring Winne 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 Winne was convicted
of multiple felonies under Federal law for conduct relating to the
regulation of a drug product under the FD&C Act. Winne was given notice
of the proposed debarment and an opportunity to request a hearing
within the timeframe prescribed by regulation. Winne submitted a
request for hearing but failed to file with the Agency information and
analysis sufficient to create a basis for a hearing.
DATES: The order is applicable August 18, 2023.
ADDRESSES: Any application for termination of debarment by Winne under
section 306(d) of the FD&C Act (21 U.S.C. 335a(d)) (application) may be
submitted 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
Submit written/paper submissions as follows:
<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-
2022-N-2558. An application will be placed in the docket and, unless
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. If you do not wish your name and contact information to be made
publicly available, you can provide this information on the cover sheet
and not in the body of your application and you must identify this
information as ``confidential.'' 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: Rachael Vieder Linowes, Office of
Scientific Integrity, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 1, Rm. 4206, Silver Spring, MD 20993,
<a href="/cdn-cgi/l/email-protection#9ccefdfff4fdf9f0b2d0f5f2f3ebf9efdcfaf8fdb2f4f4efb2fbf3ea"><span class="__cf_email__" data-cfemail="89dbe8eae1e8ece5a7c5e0e7e6feecfac9efede8a7e1e1faa7eee6ff">[email protected]</span></a>, 240-402-5931.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(a)(2)(B) of the FD&C Act mandates permanent debarment
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 29, 2022, the U.S. District Court for
the Southern District of New York entered a judgment against Winne,
after a guilty plea, for one count of conspiracy to commit wire fraud
in violation of 18 U.S.C. 1349 and one count of wire fraud in violation
of 18 U.S.C. 1343. The court sentenced Winne to 6 months in prison on
each count, to run concurrently; $1,431,524.00 in restitution; and upon
his release from prison, a 2-year supervised release for each count, to
run concurrently. The bases for his convictions stem from his
employment as a technical director with AMA Laboratories (AMA) a
consumer product testing company.
According to FDA's Office of Regulatory Affairs' (ORA's) proposal
to debar, AMA, for a fee paid by consumer product companies, purported
to test the safety and effectiveness of cosmetics, sunscreens, and
other products on a specified number of volunteer panelists. ORA found
that, from 1987 to April 2017, Winne and other AMA personnel defrauded
AMA customers by testing products on fewer panelists than were agreed
to and paid for by AMA's customers. Specifically, Winne and other AMA
personnel falsely represented to AMA's customers that AMA had tested
products on the number of pre-specified panelists and then sent those
customers fraudulent test results, which included false data.
By letter dated January 24, 2023, ORA notified Winne of a proposal
to permanently debar him from providing services in any capacity to a
person having an approved or pending drug product application, based on
the felony convictions and underlying conduct outlined above. In
addition to outlining
[[Page 56637]]
the above information, ORA found that the felony convictions were for
conduct relating to the regulation of drug products. The product
testing at issue included drug products, specifically sunscreens.\1\
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\1\ See section 201(g) of the FD&C Act (21 U.S.C. 321(g))
(defining drugs, inter alia, to include products for use in
preventing disease in man or intended to affect the structure or
function of the body); ``Sunscreen Drug Products for Over-the-
Counter Human Use,'' 43 FR 38206 at 38209 (August 25, 1978) (stating
an FDA-convened panel's conclusion that ``products intended to be
used for prevention of sunburn or any other such similar condition
should be regarded as drugs''); see also 21 CFR 201.327 (2011)
(outlining certain testing requirements for certain over-the-counter
sunscreen drug products and declaring such products to be misbranded
if SPF labeling claims not supported by adequate testing).
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On March 14, 2023, Winne submitted a request for a hearing. Winne's
request for a hearing does not provide any information or factual
analysis rebutting the findings in ORA's proposal to debar him.
Instead, Winne's request for a hearing raises three policy
considerations. First, Winne admits his wrongdoing and confirms the
appropriateness of debarment but asks FDA to consider a ``reduced
decision'' due to his ability to ``make a significant difference in the
industry by offering my unique perspective on clinical studies and
clinical data.'' Second, Winne mentions the debarment of another
individual linked to the same investigation and states that his actions
stemmed from that individual's direction. Third, Winne asserts that he
cooperated with Federal investigators throughout the investigation
process.
Under the authority delegated to her by the Commissioner of Food
and Drugs, the Chief Scientist has considered Winne's request for a
hearing. Hearings are granted only if there is a genuine and
substantial issue of fact. Hearings will not be granted on issues of
policy or law, on mere allegations, denials or general descriptions of
positions and contentions, or on data and information insufficient to
justify the factual determination urged (see 21 CFR 12.24(b)). Winne
has not raised a genuine and substantial issue of fact regarding
whether he was convicted of a felony under Federal law for conduct
relating to the regulation of a drug product under the FD&C Act.
Rather, Winne affirms that he engaged in fraudulent conduct regarding
the product testing that this conduct formed the factual basis of the
felony convictions. Insofar as Winne intends to argue that he provided
``substantial assistance'' in the investigation or prosecution of
qualifying offenses under section 306(d)(4)(C) of the FD&C Act, he may
apply for special termination of his debarment. While the statute does
not define substantial assistance, FDA ``considers a determination by
the Department of Justice concerning the substantial assistance of a
debarred individual conclusive in most cases.'' \2\
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\2\ ``Baldev Raj Bhutani; Denial of Hearing on Application for
Special Termination of Debarment,'' 77 FR 75636 at 75638 (December
12, 2012) (citing ``Amirul Islam; Grant of Special Termination;
Final Order Terminating Debarment,'' 68 FR 58352 (October 9, 2003)).
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II. Findings and Order
The Chief Scientist, under section 306(a)(2) of the FD&C Act and
under the authority delegated to her, finds that David Roy Winne has
been convicted of felonies under Federal law for conduct relating to
the regulation of a drug product under the FD&C Act. As a result of the
foregoing findings, Winne is permanently debarred from providing
services in any capacity to a person with an approved or pending drug
product application under section 505, 512, or 802 of the 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), effective (see DATES) (21 U.S.C.
335a(c)(1)(B) and (c)(2)(A)(ii) and 21 U.S.C. 321(dd)). Any person with
an approved or pending drug product application who knowingly uses the
services of Winne, in any capacity during his period of 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 Winne, during his period of debarment,
provides services in any capacity to a person with an approved or
pending drug product application, 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 applications submitted by
or with the assistance of Winne during his period of debarment.
Dated: August 14, 2023.
Namandj[eacute] N. Bumpus,
Chief Scientist.
[FR Doc. 2023-17784 Filed 8-17-23; 8:45 am]
BILLING CODE 4164-01-P
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