Notice2022-08025
Lisett Raventos: Final Debarment Order
Primary source
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Published
April 14, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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 Lisett Raventos 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 Lisett Raventos was convicted of a felony under Federal law for conduct that relates to the development or approval, including the process of development or approval, of a drug product under the FD&C Act. Ms. Raventos 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 29, 2021 (30 days after receipt of the notice), Ms. Raventos had not responded. Ms. Raventos's failure to respond and request a hearing constitutes a waiver of her right to a hearing concerning this action.
Full Text
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<title>Federal Register, Volume 87 Issue 72 (Thursday, April 14, 2022)</title>
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[Federal Register Volume 87, Number 72 (Thursday, April 14, 2022)]
[Notices]
[Pages 22218-22220]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-08025]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0313]
Lisett Raventos: 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 Lisett Raventos 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 Lisett Raventos was
convicted of a felony under Federal law for conduct that relates to the
development or approval, including the process of development or
approval, of a drug product under the FD&C Act. Ms. Raventos was given
notice of the proposed permanent debarment and was given an opportunity
to request a hearing to show why she should not be
[[Page 22219]]
debarred. As of December 29, 2021 (30 days after receipt of the
notice), Ms. Raventos had not responded. Ms. Raventos'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 14, 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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, or at
<a href="/cdn-cgi/l/email-protection#6206070003100f070c1611220406034c0a0a114c050d14"><span class="__cf_email__" data-cfemail="cda9a8afacbfa0a8a3b9be8daba9ace3a5a5bee3aaa2bb">[email protected]</span></a>.
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 5, 2021, Ms. Raventos 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, 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. Raventos
was a clinical study coordinator at Unlimited Medical Research, LLC.
From about September 2013 through June 2016, Ms. Raventos 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 fabricated; and inducing
sponsors and contract research organizations to pay money for Ms.
Raventos and her co-conspirators' own benefit. Specifically, one of Ms.
Raventos's co-conspirators entered into a contract with a Contract
Research Organization (CRO), retained by a drug manufacturer (Sponsor)
to hire clinical investigators and to manage clinical trials. Ms.
Raventos's co-conspirator entered into a contract with the CRO to
conduct a clinical trial at Unlimited Medical Research site in return
for payment. The clinical trial was for an investigational drug
intended to treat pediatric asthma in children between the ages of 4
and 11 years.
Ms. Raventos represented herself to be the Site Director, Director
of Clinical Operations, and the Study Coordinator for this clinical
trial. In those roles, Ms. Raventos was responsible for complying with
the study protocol, including administering the study drug to subjects
in the study and preparing written records, known as case histories,
which documented the participation of subjects in the clinical trial.
Ms. Raventos participated in a scheme to defraud the Sponsor by
fabricating the data and participation of subjects in the clinical
trial in a variety of ways: Ms. Raventos and her co-conspirators
falsified medical records to portray persons as legitimate study
subjects when they were not. In addition, Ms. Raventos and her co-
conspirators made it appear as though pediatric subjects made scheduled
visits to Unlimited Medical Research when they had not, made it appear
as though subjects had taken the study's drugs as required when they
had not, and made it appear that the study subjects had received checks
as payment when they had not.
As a result of this conviction, FDA sent Ms. Raventos by certified
mail on November 19, 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.
Raventos 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. Raventos 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. Raventos received
the proposal on November 29, 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.
Raventos 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. Raventos is permanently
debarred from providing services in any capacity to a person with an
approved or pending drug product application, effective (see DATES)
(see section 306(a)(2)(A) and (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. Raventos, 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. Raventos 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. Raventos 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
section 306 of the FD&C Act, a ``drug product'' is defined as a drug
subject to regulation 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) (section 201(dd) of the FD&C Act (21 U.S.C.
321(dd)).
Any application by Ms. Raventos for special termination of
debarment under section 306(d)(4) of the FD&C Act should be identified
with Docket No. FDA-2021-N-0313 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets
Management Staff (see ADDRESSES) between 9 a.m. and 4 p.m., Monday
through Friday, 240-402-7500.
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Dated: April 11, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-08025 Filed 4-13-22; 8:45 am]
BILLING CODE 4164-01-P
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