[Federal Register Volume 89, Number 86 (Thursday, May 2, 2024)]
[Notices]
[Pages 35836-35838]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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

     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. An application 
submitted electronically, including attachments, to https://www.regulations.gov 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 https://www.regulations.gov.
     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

     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.
     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 https://www.regulations.gov or at the Dockets Management 
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
     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 https://www.regulations.gov. 
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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket, go to https://www.regulations.gov 
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 [email protected].

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

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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