[Federal Register Volume 87, Number 72 (Thursday, April 14, 2022)]
[Notices]
[Pages 22218-22220]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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

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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 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, or at 
[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 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 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.


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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


