[Federal Register Volume 87, Number 42 (Thursday, March 3, 2022)]
[Notices]
[Pages 12171-12172]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 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 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 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: February 25, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-04459 Filed 3-2-22; 8:45 am]
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