Notice2022-05401
Nayade Varona: Final Debarment Order
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
March 15, 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 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.
Full Text
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<title>Federal Register, Volume 87 Issue 50 (Tuesday, March 15, 2022)</title>
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[Federal Register Volume 87, Number 50 (Tuesday, March 15, 2022)]
[Notices]
[Pages 14539-14540]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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
<a href="http://www.regulations.gov">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#c0a4a5a2a1b2ada5aeb4b380a6a4a1eea8a8b3eea7afb6"><span class="__cf_email__" data-cfemail="2642434447544b4348525566404247084e4e5508414950">[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 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 <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.
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
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