Notice2024-09528
Angela Maria Giron: Final Debarment Order
Primary source
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Published
May 2, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Angela Maria Giron, M.D. 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 Dr. Giron 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. Dr. Giron was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of February 16, 2024 (30 days after receipt of the notice), Dr. Giron has not responded. Dr. Giron's failure to respond and request a hearing constitutes a waiver of Dr. Giron's right to a hearing concerning this matter.
Full Text
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<title>Federal Register, Volume 89 Issue 86 (Thursday, May 2, 2024)</title>
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[Federal Register Volume 89, Number 86 (Thursday, May 2, 2024)]
[Notices]
[Pages 35836-35838]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-09528]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-5018]
Angela Maria Giron: Final Debarment Order
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is issuing an order
under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently
debarring Angela Maria Giron, M.D. 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 Dr. Giron 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. Dr. Giron was given notice of the
proposed debarment and an opportunity to request a hearing within the
timeframe prescribed by regulation. As of February 16, 2024 (30 days
after receipt of the notice), Dr. Giron has not responded. Dr. Giron's
failure to respond and request a hearing constitutes a waiver of Dr.
Giron's right to a hearing concerning this matter.
DATES: This order is applicable May 2, 2024.
ADDRESSES: Any application by Dr. Giron for special termination of
debarment under section 306(d)(4) of the FD&C Act (21 U.S.C.
335a(d)(4)) may be submitted at any time as follows:
Electronic Submissions
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. An application
submitted electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a> will be posted to the docket unchanged. Because
your application will be made public, you are solely responsible for
ensuring that your application does not include any confidential
information that you or a third party may not wish to be posted, such
as medical information, your or anyone else's Social Security number,
or confidential business information, such as a manufacturing process.
Please note that if you include your name, contact information, or
other information that identifies you in the body of your application,
that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit an application with confidential
information that you do not wish to be made available to the public,
submit the application as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For a written/paper application submitted to the Dockets
Management Staff, FDA will post your application, as well as any
attachments, except for information submitted, marked, and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All applications must include the Docket No. FDA-
2023-N-5018. Received applications will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit an application with
confidential information that you do not wish to be made publicly
available, submit your application only as a written/paper submission.
You should submit two copies total. One copy will include the
information you claim to be confidential with a heading or cover note
that states
[[Page 35837]]
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of your application. The second copy, which will have
the claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. Any information
marked as ``confidential'' will not be disclosed except in accordance
with 21 CFR 10.20 and other applicable disclosure law. For more
information about FDA's posting of comments to public dockets, see 80
FR 56469, September 18, 2015, or access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
and insert the docket number, found in brackets in the heading of this
document, into the ``Search'' box and follow the prompts and/or go to
the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852 between 9 a.m. and 4 p.m., Monday through Friday. Publicly
available submissions may be seen in the docket.
FOR FURTHER INFORMATION CONTACT: Jaime Espinosa, Division of Compliance
and Enforcement, Office of Policy, Compliance, and Enforcement, Office
of Regulatory Affairs, Food and Drug Administration, at 240-402-8743,
or <a href="/cdn-cgi/l/email-protection#7c18191e1d0e111912080f3c1a181d5214140f521b130a"><span class="__cf_email__" data-cfemail="e98d8c8b889b848c879d9aa98f8d88c781819ac78e869f">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(a)(2)(A) of the FD&C Act 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. On September 11, 2023,
Dr. Giron was convicted as defined in section 306(l)(1) of the FD&C Act
in the United States 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 underlying facts
supporting the conviction are as follows: As contained in the
Information and the Factual Proffer in Support of Guilty Plea, from Dr.
Giron's case, she was a licensed physician and served as a clinical
investigator at AMB Research Center, Inc. (AMB), a medical clinic
located in Miami, Florida. AMB conducted clinical trials of new drugs
for pharmaceutical companies and other sponsors. AMB entered into a
Clinical Trial Agreement with a Clinical Research Organization (CRO)
that managed and oversaw a clinical trial designed to evaluate the
safety and efficacy of an investigational drug intended to treat
persons with Clostridium difficile-associated diarrhea (CDAD clinical
trial) on behalf of a sponsor (a pharmaceutical company). Dr. Giron
agreed to serve as the clinical investigator, also known as the
principal investigator, for the CDAD clinical trial at AMB and signed
the Form FDA 1572, Statement of Investigator, for the CDAD clinical
trial. By signing the Form FDA 1572, she knew that as the clinical
investigator she was required to, among other things, (1) conduct the
CDAD clinical trial according to the study protocol and in compliance
with all applicable Federal regulations; (2) personally conduct and
supervise the CDAD clinical trial; (3) obtain informed consent from the
subjects; and (4) comply with the clinical trial protocol and
applicable Federal regulations relating to obtaining informed consent
and the informed consent process.
As the CDAD principal investigator, Dr. Giron was also responsible
for complying with all requirements regarding the eligibility of
subjects in accordance with the protocol; dispensing study medication;
collecting and reporting data; reporting adverse events; and ensuring
that all employees working on the study met those same obligations. Dr.
Giron was also required to prepare and maintain case histories which
were records relating to the CDAD clinical trial. These case histories
for each subject participating in the CDAD clinical trial included
informed consent forms and medical records, drug dispensation records,
and records of all observations and other data pertinent to the CDAD
clinical trial.
For purposes of obtaining money from the Sponsor and/or CRO, Dr.
Giron, along with her co-conspirators, created false and fraudulent
study records. For example, electronic case record files (eCRFs)
falsely represented that the subjects completed the informed consent
form (ICF) process, which required Dr. Giron to review the ICF with
each subject and personally obtain the subject's written informed
consent. In truth and fact, Dr. Giron did not obtain written informed
consent for any of the 22 subjects enrolled in the CDAD clinical trial.
Dr. Giron knew that the study subjects did not participate in the CDAD
clinical trial in accordance with the study protocol and applicable
Federal regulations.
In addition, along with her co-conspirators, Dr. Giron falsified
data of enrolled subjects in the CDAD clinical trial. For example, Dr.
Giron did not conduct the required clinical investigator assessments at
the second, third and fifth visits. She also knew that falsified and
fraudulent information was submitted in case report forms and eCRFs
falsely representing she had completed those required assessments
according to the protocol. Furthermore, Dr. Giron also knew that false
information and data was submitted in the case report forms and eCRFs
representing that the subjects had satisfied eligibility criteria to
participate in the CDAD clinical trial, received and taken the study
medication, and completed the required documents and journals.
After an on-site audit of AMB by the Sponsor in April 2017, the
Sponsor notified the FDA in writing of potential scientific misconduct
by AMB. The Institutional Review Board for the CDAD clinical trial sent
AMB a copy of the Sponsor's notification to FDA. Dr. Giron, along with
a co-conspirator, signed a letter entitled ``Site response to the
Notification of Potential Scientific Misconduct.'' At the time of
signing that response letter Dr. Giron knew that it contained
materially false and fraudulent representations including that (1) she
was present for all subjects' informed consent and gave each subject
the time to understand, read, and resolve any questions prior to
signing the informed consent form; (2) AMB took special care with ICF
signatures and the ICF process to ensure that subjects understood the
study and its risks and could make an informed decision whether to
participate; (3) all participating subjects had completed the study
treatment and follow up visits; and (4) she and AMB site staff acted in
accordance with the study protocol to the best of their knowledge. Dr.
Giron received $58,119.60 in proceeds for the CDAD clinical trial. AMB
received more than $250,000 for the CDAD clinical trial.
As a result of this conviction, FDA sent Dr. Giron, by certified
mail, on January 10, 2024, 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), that Dr. Giron was 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
[[Page 35838]]
product. The proposal informed Dr. Giron of the proposed debarment and
offered her 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 a waiver
of the opportunity for a hearing and of any contentions concerning this
action. Dr. Giron received the proposal and notice of opportunity for a
hearing on January 17, 2024. Dr. Giron failed to request a hearing
within the timeframe prescribed by regulation and has, therefore,
waived her opportunity for a hearing and waived 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 Angela
Maria Giron, M.D. 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.
As a result of the foregoing finding, Dr. Giron 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,
(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 in any capacity the services of Dr. Giron
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 Dr. Giron
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 Dr. Giron during her 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 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))).
Dated: April 29, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-09528 Filed 5-1-24; 8:45 am]
BILLING CODE 4164-01-P
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