[Federal Register Volume 88, Number 159 (Friday, August 18, 2023)]
[Notices]
[Pages 56636-56637]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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

     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

    Submit written/paper submissions as follows:
     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-
2022-N-2558. An application will be placed in the docket and, unless 
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. 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: 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: Rachael Vieder Linowes, Office of 
Scientific Integrity, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 1, Rm. 4206, Silver Spring, MD 20993, 
[email protected], 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

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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