[Federal Register Volume 87, Number 50 (Tuesday, March 15, 2022)]
[Notices]
[Pages 14539-14540]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-05401]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0968]


Nayade Varona: 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 Nayade Varona 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 Ms. Varona was 
convicted of a felony under Federal law for conduct related to the 
development or approval, including the process for development or 
approval, of any drug product under the FD&C Act. Ms. Varona 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 22, 2021 (30 days after receipt of the notice), Ms. Varona had 
not responded. Ms. Varona's failure to respond and request a hearing 
within the prescribed timeframe constitutes a waiver of her right to a 
hearing concerning this action.

DATES: This order is applicable March 15, 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 
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 August 11, 2021, Ms. Varona was 
convicted as defined in section 306(l)(1) of the FD&C Act in the U.S. 
District Court for the Southern District of Florida, Miami Division, 
when the court accepted her plea of guilty and entered judgment against 
her for one count of Conspiracy to Defraud the United States in 
violation of 18 U.S.C. 371.
    The factual basis for this conviction is as follows: As contained 
in the Information, entered into the docket on March 16, 2021, and the 
Factual Proffer in Support of Ms. Varona's guilty plea, entered into 
the docket on June 8, 2021, both from her case, Ms. Varona was employed 
as an assistant study coordinator at Tellus Clinical Research (Tellus). 
Tellus was a medical clinic that conducted clinical trials on behalf of 
pharmaceutical company sponsors. A drug manufacturer (Sponsor) 
initiated a clinical trial concerning a new investigational drug 
intended to treat patients suffering from irritable bowel syndrome 
(Study or IBS Trial). The Sponsor retained a Contract Research 
Organization (CRO) to manage various aspects of the IBS Trial. CRO 
entered into a contract with Tellus and Martin Valdes, a medical doctor 
serving as a clinical investigator for clinical trials conducted at 
Tellus and as the clinical investigator for the IBS Trial. The study 
protocol for the IBS Trial required subjects to make periodic scheduled 
visits to the clinical trial site for which they were paid $100 per 
visit. During some of these visits, subjects were required to provide 
blood samples for pharmacokinetic analysis, receive physical exams by 
clinical trial staff, and undergo electrocardiograms. Subjects were 
also required to use an ``e-diary'' system to report their daily 
experience with the Study drugs. They would do this by making daily 
phone calls to a number maintained by a third party and answering 
automated questions nonverbally by touch-tone buttons.
    In her role as an assistant study coordinator, Ms. Varona was 
responsible for administering procedures to subjects in the Study and 
creating written records reflecting the participation in the Study. 
However, Ms. Varona and her co-conspirators engaged in an effort to 
impair, impede, and obstruct FDA's legitimate function of regulating 
clinical trials of drugs in order to obtain money. Ms. Varona and her 
co-conspirators did this by fabricating medical records to portray 
persons as legitimate Study subjects when they were not. She and her 
co-conspirators falsified these records to make it appear that the 
Study subjects had consented to participating in the Study, satisfied 
the Study's eligibility criteria, appeared for scheduled visits at the 
Study's site, taken Study drugs as required, and received checks as 
payment for site visits, among other things. For example, Ms. Varona 
represented that she had seen a purported Study subject, spoken to her 
about her dietary habits, lifestyle, and exercise regimen, collected a 
urine sample, taken vital signs, and dispensed the Study drug to her 
when Ms. Varona well knew that the individual was not a Study subject 
and that these representations were false. Ms. Varona also knew that 
one or more of her co-conspirators placed telephone calls to the e-
diary system for the purposes of reporting fabricated data on behalf of 
purportedly legitimate Study subjects.
    As a result of this conviction, FDA sent Ms. Varona by certified 
mail on November 8, 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. Varona 
was convicted, as set forth in section 306(l)(1) of the FD&C Act, of a 
felony under Federal law for conduct relating to the development or 
approval, including the process of development or

[[Page 14540]]

approval, of any drug product under the FD&C Act. The proposal also 
offered Ms. Varona 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. Varona received the 
proposal on November 22, 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. 
Varona 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. Varona 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, (21 
U.S.C. 355a(2)(A) and 335a(c)(2)(A)(ii))). 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. 
Varona 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. Varona 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. Varona 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 the FD&C 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. Varona for special termination of debarment 
under section 306(d)(4) of the FD&C Act should be identified with 
Docket No. FDA-2021-N-0968 and sent to the Division of Dockets 
Management (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: March 3, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-05401 Filed 3-14-22; 8:45 am]
BILLING CODE 4164-01-P