[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]
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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.
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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 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
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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
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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]
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