Notice2022-16507
Duniel Tejeda: 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
August 2, 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 Duniel Tejeda 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 Duniel Tejeda 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. Duniel Tejeda 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 April 20, 2022 (30 days after receipt of the notice), Mr. Tejeda had not responded. Mr. Tejeda'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
<html>
<head>
<title>Federal Register, Volume 87 Issue 147 (Tuesday, August 2, 2022)</title>
</head>
<body><pre>
[Federal Register Volume 87, Number 147 (Tuesday, August 2, 2022)]
[Notices]
[Pages 47218-47220]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-16507]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-0101]
Duniel Tejeda: Final Debarment Order
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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 Duniel Tejeda 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 Duniel Tejeda 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. Duniel Tejeda 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 April 20, 2022 (30 days after receipt of the notice), Mr. Tejeda
had not responded. Mr. Tejeda'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 August 2, 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#45212027243728202b3136052321246b2d2d366b222a33"><span class="__cf_email__" data-cfemail="0266676063706f676c7671426466632c6a6a712c656d74">[email protected]</span></a>.
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
[[Page 47219]]
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 January 20, 2022,
Mr. Duniel Tejeda 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 commit mail
and wire fraud in violation of 18 U.S.C. 1349.
As contained in the indictment, entered into the docket on February
24, 2021, and the Factual Proffer in support of Mr. Tejeda's guilty
plea, entered into the docket on October 26, 2021, both from his case,
Mr. Tejeda was a project manager and study coordinator employed at
Tellus Clinical Research, Inc. (``Tellus''). Tellus was a medical
research clinic located in Miami, Florida that conducted clinical
trials on behalf of pharmaceutical companies and other sponsors. Among
the clinical research trials conducted by Tellus were two studies of an
investigational drug intended to treat opioid dependency, sponsored by
Sponsor 1 and managed by clinical research organization (CRO) 1
(collectively, ``the opioid dependency trials''); two studies of an
investigational drug intended to treat irritable bowel syndrome in
female subjects, sponsored by Sponsor 2 and managed by CRO 2
(collectively, ``the IBS trials''); and one study of an investigational
injectable drug intended to treat diabetic nephropathy, sponsored by
Sponsor 3 and managed by CRO 3 (``the diabetes trial''). In Mr.
Tejeda's roles with Tellus, he conspired with others to defraud these
sponsors and CROs responsible for initiating and overseeing these
clinical trials. For the purpose of obtaining money by means of
materially false and fraudulent pretenses, representations, and
promises, Mr. Tejeda, along with his co-conspirators, caused false
information to be entered in subject case histories to make it appear
that subjects had, among other things, satisfied the eligibility
criteria to participate in the studies, provided informed consent to
participate in the studies, received proper physical examinations,
received or had been administered the investigational drug that was the
subject of each clinical trial, and received payments for visits to
Tellus for the clinical trials, when in fact Mr. Tejeda knew that such
events had not occurred. As an example of Mr. Tejeda's specific conduct
to further this scheme, in one of the opioid dependency trials, Mr.
Tejeda entered his initials in the case history documentation for one
of the study subjects to represent falsely that he had administered
multiple doses of the investigational drug to the subject as required
by the study protocol, and that this drug administration was witnessed
by one of Mr. Tejeda's co-conspirators. As Mr. Tejeda well knew, these
representations were false because the study subject was not
participating in the study, Mr. Tejeda did not dose them with the study
medication, and the dosing was not witnessed by Mr. Tejeda's co-
conspirator.
In another instance, in connection to one of the IBS trials, Mr.
Tejeda wrote a check, endorsed by one of his co-conspirators, to a
study participant for their purported participation in a study visit.
As Mr. Tejeda well knew, the individual was not in fact participating
in the study and had not received the check. Mr. Tejeda deposited that
check in his own bank account. Further, as part of the IBS trials,
study subjects were required to make daily phone calls to an ``e-
diary'' system (a toll-free number maintained by a third party) and
report their personal experience with the study drug. Using the
subjects' individual personal identification numbers, Mr. Tejeda, along
with one or more of his co-conspirators, placed telephone calls to this
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. Tejeda by certified
mail on March 1, 2022, 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. Tejeda 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. Tejeda 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 his debarment. Mr. Tejeda received the proposal on March 21,
2022. 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.
Tejeda 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. Tejeda 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. 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. Tejeda 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 during his period of
debarment Mr. Tejeda provides services in any capacity to a person with
an approved or pending drug product application, 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. Tejeda during his period of debarment, other than in connection
with an audit under section 306 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 this 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 Mr. Tejeda for special termination of debarment
under section 306(d)(4) of the FD&C Act should be identified with
Docket No. FDA-2022-N-0101 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.
[[Page 47220]]
Dated: July 25, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-16507 Filed 8-1-22; 8:45 am]
BILLING CODE 4164-01-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on August 2, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.