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[Federal Register Volume 89, Number 223 (Tuesday, November 19, 2024)]
[Notices]
[Pages 91406-91408]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-26912]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-3111]

Ivette Maria Portela Martinez: 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 Ivette Maria Portela Martinez 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 Ms. Portela 
Martinez was convicted of two felonies under Federal law for conduct 
relating to the development or approval, including the process for 
development or approval, of any drug product. Ms. Portela Martinez was 
given notice of the proposed debarment and an opportunity to request a 
hearing within the timeframe prescribed by regulation. As of September 
14, 2024 (30 days after receipt of the notice), Ms. Portela Martinez 
has not responded. Ms. Portela Martinez's failure to respond and 
request a hearing constitutes a waiver of Ms. Portela Martinez's right 
to a hearing concerning this matter.

[[Page 91407]]

DATES: This order is applicable November 19, 2024.

ADDRESSES: Any application by Ms. Portela Martinez 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-
2024-N-3111. 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 ``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, 240-402-
7500. Publicly available submissions may be seen in the docket.

FOR FURTHER INFORMATION CONTACT: Jaime Espinosa, Division of Field 
Enforcement, Office of Field Regulatory Operations, Office of 
Inspections and Investigations, Food and Drug Administration, 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 November 30, 2023, Ms. 
Portela Martinez 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 entered judgment against her, 
after a jury trial, for one count of conspiracy to commit wire fraud in 
violation of 18 U.S.C. 1349 and one count of wire fraud in violation of 
18 U.S.C. 1343.
    The underlying facts supporting the conviction are as follows: as 
contained in the witness testimony reflected in the transcripts from 
her trial, Ms. Portela Martinez worked for 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. At AMB, Ms. Portela Martinez served as recruiter, site 
manager, data entry specialist, and pharmacist. In March 2016, AMB 
entered into a Clinical Trial Agreement with a Contract 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). Ms. 
Portela Martinez, along with her co-conspirators, entered into a 
conspiracy to cause the sponsor and/or the CRO to make payments on the 
contracts for the CDAD clinical trial, by making false and fraudulent 
representations regarding, among other things, subject eligibility for 
and participation in the CDAD clinical trial, and falsifying and 
fabricating documents, data, and other items relating to the CDAD 
clinical trial including subject informed consent forms, case 
histories, and data. Ms. Portela Martinez participated with two other 
co-conspirators with falsifying and fabricating study documents. Ms. 
Portela Martinez and her co-conspirators falsified the study data of 
subjects who did not participate in the CDAD clinical trial in full 
compliance with the protocol. Ms. Portela Martinez participated in 
falsifying the consent forms and falsifying subjects' signatures to 
make it appear as though the patients had consented to participate in 
the clinical trial when they had not.
    For purposes of obtaining money from the sponsor and/or CRO, Ms. 
Portela Martinez, along with her co-conspirators, created false and 
fraudulent study records, and submitted fraudulent stool and blood 
samples. For example, electronic case record files (eCRFs) falsely 
represented that the subjects completed the informed consent form (ICF) 
process with the Principal Investigator which required her to review 
the ICF with each subject and personally obtain the subject's written 
informed consent. In fact, the Principal Investigator never completed 
the ICF process with subjects, and some subjects had never been to AMB 
or did not participate in the trial. Ms. Portela Martinez knew that 
false information and data was submitted in the case report forms and 
eCRFs including false information and data representing that subjects 
had satisfied eligibility criteria

[[Page 91408]]

to participate in the CDAD clinical trial, received and taken the study 
medication, provided stool samples, completed the required documents 
and journals, and participated in assessments conducted by the clinical 
investigator. In addition, Ms. Portela Martinez knew that 10 or more 
individuals' means of identification were used unlawfully or without 
authority in furtherance of the conspiracy. Specifically, Ms. Portela 
Martinez, along with some of her co-conspirators, used the means of 
identification of real persons, to create subject identification 
numbers for those persons, and then used those subject identification 
numbers to falsely portray the persons as legitimate subjects in the 
CDAD clinical trial, when in fact they were not. In addition, Ms. 
Portela Martinez along with her co-conspirators submitted her own stool 
and blood samples to make it appear as if they came from study 
participants.
    Furthermore, Ms. Portela Martinez was one of only two individuals 
who inputted CDAD clinical trial data in the Almac Clinical Technology 
Integrated Response Technology database (Almac database). The 
information in the Almac database was the foundation for all subsequent 
subject CDAD clinical trial data. Ms. Portela Martinez repeatedly 
entered false and fabricated subject screening and randomization 
information in the Almac database.
    Ms. Portela Martinez received $19,620 in proceeds for the CDAD 
clinical trial. AMB received over $277,000 for the CDAD clinical trial.
    FDA sent Ms. Portela Martinez, by certified mail, on August 12, 
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) of the FD&C Act, that Ms. Portela Martinez 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 product. The proposal informed Ms. Portela 
Martinez 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. Ms. Portela 
Martinez received the proposal and notice of opportunity for a hearing 
on August 15, 2024. Ms. Portela Martinez 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 Division of Field Enforcement Director, Office of 
Inspections and Investigations, under section 306(a)(2)(A) of the FD&C 
Act, under authority delegated to the Division of Field Enforcement 
Director, finds that Ms. Ivette Maria Portela Martinez 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, Ms. Portela Martinez 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 in any capacity the services of Ms. Portela Martinez 
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 Ms. Portela 
Martinez 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 Ms. Portela Martinez during her period of 
debarment, other than in connection with an audit under section 306 of 
the FD&C Act (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, 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: November 7, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2024-26912 Filed 11-18-24; 8:45 am]
BILLING CODE 4164-01-P
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