```

[Federal Register Volume 89, Number 224 (Wednesday, November 20, 2024)]
[Notices]
[Pages 91758-91760]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-27093]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-3110]

Miguel Angel Montalvo Villa: Final Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is issuing an order 
under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently 
debarring Miguel Angel Montalvo Villa 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. Montalvo Villa 
was convicted of multiple felonies under Federal law for conduct 
relating to the development or approval, including the process for 
development or approval, of any drug product. Mr. Montalvo Villa was 
given notice of the proposed debarment and an opportunity to request a 
hearing within the timeframe prescribed by regulation. As of September 
19, 2024 (30 days after receipt of the notice), Mr. Montalvo Villa has 
not responded. Mr. Montalvo Villa's failure to respond and request a 
hearing constitutes a waiver of Mr. Montalvo Villa's right to a hearing 
concerning this matter.

DATES: This order is applicable November 20, 2024.

ADDRESSES: Any application by Mr. Montalvo Villa 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

[[Page 91759]]

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-3110. 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, Mr. 
Montalvo Villa 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 him, 
after a jury trial, for three offenses, one count of conspiracy to 
commit wire fraud in violation of 18 U.S.C. 1349, one count of wire 
fraud in violation of 18 U.S.C. 1343, and one count of false statements 
in violation of 18 U.S.C. 1001(a)(2). The underlying facts supporting 
the conviction are as follows: as contained in the witness testimony 
reflected in the transcripts from Mr. Montalvo Villa's trial, from 
around January 2015, through about March 2018, Mr. Montalvo Villa was 
the co-owner of 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, Mr. Montalvo 
Villa was the majority owner and served as President. 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).
    Mr. Montalvo Villa, along with his 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.
    Mr. Montalvo Villa participated with two other co-conspirators with 
falsifying and fabricating study documents. Mr. Montalvo Villa and his 
co-conspirators falsified the study data of subjects who did not 
participate in the CDAD clinical trial in full compliance with the 
protocol. Mr. Montalvo Villa was primarily responsible in completing 
the patients' informed consent form and falsifying their 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, Mr. 
Montalvo Villa along with his 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, she never completed the ICF process with 
subjects, and some subjects had never been to AMB or did not 
participate in the trial. Mr. Montalvo Villa 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 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, Mr. 
Montalvo Villa knew that 10 or more individuals' means of 
identification were used unlawfully or without authority in furtherance 
of the conspiracy. Specifically, Mr. Montalvo Villa, along with some of 
his 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

[[Page 91760]]

the persons as legitimate subjects in the CDAD clinical trial, when in 
fact they were not. Mr. Montalvo Villa was primarily responsible for 
completing the patients' informed consent form and falsifying their 
signatures to make it appear as though the patients consented to 
participate in the clinical trial when they had not. In addition, Mr. 
Montalvo Villa along with his co-conspirators submitted his own stool 
and blood samples to make it appear as if they came from study 
participants.
    Furthermore, Mr. Montalvo Villa 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. Mr. Montalvo Villa repeatedly entered 
false and fabricated subject screening and randomization information in 
the Almac database.
    After an on-site audit by the Sponsor of AMB, the Sponsor notified 
the FDA in writing of potential scientific misconduct by AMB. Mr. 
Montalvo Villa wrote AMB's response letter, which contained false 
information, for the Principal Investigator's signature. Mr. Montalvo 
Villa told the Principal Investigator that she would lose her medical 
license if she did not sign the letter. In addition, an FDA regulatory 
investigator conducted an official on-site inspection of AMB for the 
CDAD clinical trial that began on February 20, 2018. On the first day 
of the inspection, Mr. Montalvo Villa told the FDA investigator that 
during the CDAD clinical trial he was present when his co-conspirator, 
the Principal Investigator, had obtained all the informed consents from 
the trial subjects. Mr. Montalvo Villa also told the regulatory 
investigator that copies of the informed consent were given to the 
subjects and that he was the most responsible person at AMB.
    Mr. Montalvo Villa received $100,634.84 in proceeds for the CDAD 
clinical trial. AMB received over $277,000 for the CDAD clinical trial.
    FDA sent Mr. Montalvo Villa, by certified mail, on August 12, 2024, 
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. Montalvo Villa 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 Mr. Montalvo Villa of the proposed 
debarment and offered him 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 a waiver of the opportunity for a hearing and of any 
contentions concerning this action. Mr. Montalvo Villa received the 
proposal and notice of opportunity for a hearing on August 20, 2024. 
Mr. Montalvo Villa failed to request a hearing within the timeframe 
prescribed by regulation and has, therefore, waived his opportunity for 
a hearing and waived any contentions concerning his 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 Mr. Miguel Angel Montalvo Villa 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, Mr. Montalvo Villa 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 Mr. Montalvo Villa 
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. Montalvo 
Villa 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. Montalvo Villa during his 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. 2024-27093 Filed 11-19-24; 8:45 am]
BILLING CODE 4164-01-P
```