Notice2022-04459
Eduardo Navarro: 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 3, 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 Eduardo Navarro 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 Mr. Navarro was convicted of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of any drug product under the FD&C Act. Mr. Navarro was given notice of the proposed permanent debarment and was given an opportunity to request a hearing to show why he should not be debarred. As of December 24, 2021 (30 days after receipt of the notice), Mr. Navarro had not responded. Mr. Navarro's failure to respond and request a hearing within the prescribed timeframe constitutes a waiver of his right to a hearing concerning this action.
Full Text
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<title>Federal Register, Volume 87 Issue 42 (Thursday, March 3, 2022)</title>
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[Federal Register Volume 87, Number 42 (Thursday, March 3, 2022)]
[Notices]
[Pages 12171-12172]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-04459]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0964]
Eduardo Navarro: 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 Eduardo Navarro 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 Mr. Navarro was
convicted of a felony under Federal law for conduct relating to the
development or approval, including the process for development or
approval, of any drug product under the FD&C Act. Mr. Navarro was given
notice of the proposed permanent debarment and was given an opportunity
to request a hearing to show why he should not be debarred. As of
December 24, 2021 (30 days after receipt of the notice), Mr. Navarro
had not responded. Mr. Navarro's failure to respond and request a
hearing within the prescribed timeframe constitutes a waiver of his
right to a hearing concerning this action.
DATES: This order is applicable March 3, 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#690d0c0b081b040c071d1a290f0d084701011a470e061f"><span class="__cf_email__" data-cfemail="187c7d7a796a757d766c6b587e7c793670706b367f776e">[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, Mr. Navarro 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 his plea of guilty and entered judgment against
him 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 his guilty plea, entered
[[Page 12172]]
into the docket on June 8, 2021, both from his case, Mr. Navarro was an
advanced Registered Nurse Practitioner employed as a sub-investigator
at Tellus Clinical Research (Tellus) under the direction of a clinical
investigator. 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. The 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 his role as a sub-investigator, Mr. Navarro was responsible for
conducting physical exams on subjects, reviewing lab work and
electrocardiograms, and preparing case histories reflecting the
participation of subjects in the Study. However, Mr. Navarro and his
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. Mr. Navarro and his co-conspirators did this by
fabricating medical records to portray persons as legitimate Study
subjects when they were not. He and his 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, Mr. Navarro represented that he had seen a
purported Study subject and performed a physical examination of her
when he knew she was not a Study subject and these representations were
false. Mr. Navarro also knew that one or more of his 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 Mr. Navarro by certified
mail on November 8, 2021, a notice proposing to permanently debar him
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 Mr. Navarro
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 approval, of any drug
product under the FD&C Act. The proposal also offered Mr. Navarro an
opportunity to request a hearing, providing him 30 days from the date
of receipt of the letter in which to file the request, and advised him
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. Mr. Navarro received the proposal on November
24, 2021. He did not request a hearing within the timeframe prescribed
by regulation and has, therefore, waived his opportunity for a hearing
and any contentions concerning his 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 Mr.
Navarro 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, Mr. Navarro 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 Mr. Navarro in any capacity during his
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 Mr. Navarro provides
services in any capacity to a person with an approved or pending drug
product application during his period of debarment, he 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 Mr. Navarro during his period of debarment, other than
in connection with an audit under 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, 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 Mr. Navarro for special termination of debarment
under section 306(d)(4) of the FD&C Act should be identified with
Docket No. FDA-2021-N-0964 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.
Dated: February 25, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-04459 Filed 3-2-22; 8:45 am]
BILLING CODE 4164-01-P
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