[Federal Register Volume 87, Number 75 (Tuesday, April 19, 2022)]
[Notices]
[Pages 23184-23185]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-08302]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0317]


Yvelice Villaman-Bencosme: 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 issuing an 
order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) 
permanently debarring Yvelice Villaman-Bencosme 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 Yvelice 
Villaman-Bencosme was convicted of a felony under Federal law for 
conduct relating to the development or approval, including the process 
of development or approval, of a drug product under the FD&C Act. Ms. 
Villaman-Bencosme was given notice of the proposed permanent debarment 
and was given an opportunity to request a hearing to show why she 
should not be debarred. As of December 13, 2021 (30 days after receipt 
of the notice), Ms. Villaman-Bencosme had not responded. Ms. Villaman-
Bencosme's failure to respond and request a hearing constitutes a 
waiver of her right to a hearing concerning this action.

DATES: This order is applicable April 19, 2022.

ADDRESSES: Submit applications for termination of debarment to the 
Dockets Management Staff, Food and Drug Administration, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, or at https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Jaime Espinosa, Division of 
Enforcement (ELEM-4029), Office of Strategic Planning and Operational 
Policy, Office of Regulatory Affairs, Food and Drug Administration, 
12420 Parklawn Dr., Rockville, MD 20857, 240-402-8743, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(a)(2)(A) of the FD&C Act (21 U.S.C. 335a(a)(2)(A)) 
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 development or 
approval, including the process of development or approval, of any drug 
product under the FD&C Act. On March 19, 2021, Ms. Villaman-Bencosme 
was convicted as defined in section 306(l)(1) of the FD&C Act when 
judgment was entered against her in the U.S. District Court for the 
Southern District of Florida-Miami Division, after her plea of guilty, 
to one count of Conspiracy to Commit Wire Fraud in violation of 18 
U.S.C. 1349.
    The factual basis for this conviction is as follows: Ms. Villaman-
Bencosme was a licensed medical doctor who served as a clinical 
investigator at Unlimited Medical Research, LLC from about September 
2013 through June 2016. Ms. Villaman-Bencosme conspired with others to 
unlawfully enrich herself by making materially false representations 
about clinical trials; fabricating data and the participation of 
subjects in those clinical trials; concealing from FDA, sponsors, and 
contract research organizations the fact that the data and 
participation of subjects had been

[[Page 23185]]

fabricated; and inducing sponsors and contract research organizations 
to pay money for Ms. Villaman-Bencosme and her co-conspirators' own 
benefit. On or about October 25, 2013, Ms. Villaman-Bencosme entered 
into a contract with a Contract Research Organization retained by a 
drug manufacturer (Sponsor) to serve as a clinical investigator for a 
clinical trial initiated by the Sponsor. The study was for an 
investigational drug intended to treat pediatric asthma in children 
between the ages of 4 and 11 years. As the clinical investigator Ms. 
Villaman-Bencosme was responsible for all aspects of the study to 
include ensuring that subjects provided informed consent and understood 
the risks of participating in the study, reporting adverse events to 
the Sponsor, and maintaining honest and accurate records known as 
``case histories.'' Instead, Ms. Villaman-Bencosme used personal 
identification information from pediatric patient medical records 
maintained at her private medical practice to falsify case histories. 
This included a number of false details. Ms. Villaman-Bencosme made it 
appear that: The study subjects satisfied the eligibility criteria to 
participate in the study; the subjects received a physical examination 
from her; the patients received the study drug at the study site; the 
patients returned the study drug to the study site; and the patients 
received payment for visits to the study site.
    As a result of this conviction, FDA sent Ms. Villaman-Bencosme by 
certified mail on November 3, 2021, a notice proposing to permanently 
debar her 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)(A) of the FD&C Act, that Ms. 
Villaman-Bencosme was convicted of a felony under Federal law for 
conduct relating to the development or approval, including the process 
of development or approval, of any drug product under the FD&C Act. The 
proposal also offered Ms. Villaman-Bencosme an opportunity to request a 
hearing, providing her 30 days from the date of receipt of the letter 
in which to file the request, and advised her that failure to request a 
hearing constituted an election not to use the opportunity for a 
hearing and a waiver of any contentions concerning this action. Ms. 
Villaman-Bencosme received the proposal on November 13, 2021. She did 
not request a hearing within the timeframe prescribed by regulation and 
has, therefore, waived her opportunity for a hearing and any 
contentions concerning her 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)(A) of the FD&C Act, under 
authority delegated to the Assistant Commissioner, finds that Ms. 
Villaman-Bencosme has been convicted of a felony under Federal law for 
conduct relating to the development or approval, including the process 
of development or approval, of any drug product under the FD&C Act.
    As a result of the foregoing finding, Ms. Villaman-Bencosme, 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)(A) 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 the services of Ms. Villaman-Bencosme, in any capacity 
during her 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 Ms. Villaman-
Bencosme provides services in any capacity to a person with an approved 
or pending drug product application during her period of debarment, she 
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 Ms. Villaman-Bencosme during her 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 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)).
    Any application by Ms. Villaman-Bencosme for special termination of 
debarment under section 306(d)(4) of the FD&C Act should be identified 
with Docket No. FDA-2021-N-0317 and sent to the Dockets Management 
Staff (see ADDRESSES). The public availability of information in these 
submissions is governed by 21 CFR 10.20.
    Publicly available submissions will be placed in the docket and 
will be viewable at https://www.regulations.gov or at the Dockets 
Management Staff (see ADDRESSES) between 9 a.m. and 4 p.m., Monday 
through Friday, 240-402-7500.

    Dated: April 12, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-08302 Filed 4-18-22; 8:45 am]
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