Miguel Angel Montalvo Villa: Final Debarment Order, 91758-91760 [2024-27093]
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91758
Federal Register / Vol. 89, No. 224 / Wednesday, November 20, 2024 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–P–3699]
Determination That IC-GREEN
(Indocyanine Green), 25 Milligrams/
Vial, Was Not Withdrawn From Sale for
Reasons of Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined that IC-GREEN (indocyanine
green), 25 milligrams (mg)/vial, was not
withdrawn from sale for reasons of
safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for IC-GREEN
(indocyanine green), 25 mg/vial, if all
other legal and regulatory requirements
are met.
FOR FURTHER INFORMATION CONTACT:
Madeleine Giaquinto, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6219,
Silver Spring, MD 20993–0002,
Madeleine.Giaquinto@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Section
505(j) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
355(j)) allows the submission of an
ANDA to market a generic version of a
previously approved drug product. To
obtain approval, the ANDA applicant
must show, among other things, that the
generic drug product: (1) has the same
active ingredient(s), dosage form, route
of administration, strength, conditions
of use, and (with certain exceptions)
labeling as the listed drug, which is a
version of the drug that was previously
approved, and (2) is bioequivalent to the
listed drug. ANDA applicants do not
have to repeat the extensive clinical
testing otherwise necessary to gain
approval of a new drug application
(NDA).
Section 505(j)(7) of the FD&C Act
requires FDA to publish a list of all
approved drugs. FDA publishes this list
as part of the ‘‘Approved Drug Products
With Therapeutic Equivalence
Evaluations,’’ which is known generally
as the ‘‘Orange Book.’’ Under FDA
regulations, drugs are removed from the
list if the Agency withdraws or
suspends approval of the drug’s NDA or
ANDA for reasons of safety or
effectiveness or if FDA determines that
the listed drug was withdrawn from sale
for reasons of safety or effectiveness (21
CFR 314.162).
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SUMMARY:
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A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
IC-GREEN (indocyanine green), 25
mg/vial, is the subject of NDA 11525,
held by Renew Pharmaceuticals and
initially approved on February 9, 1959.
IC-GREEN, 25 mg/vial, is indicated for
determining cardiac output, hepatic
function, and liver blood flow.
IC-GREEN (indocyanine green), 25
mg/vial, is currently listed in the
‘‘Discontinued Drug Product List’’
section of the Orange Book.
Zydus Pharmaceuticals (USA), Inc.
submitted a citizen petition dated
August 2, 2024 (Docket No. FDA–2024–
P–3699), under 21 CFR 10.30,
requesting that the Agency determine
whether IC-GREEN (indocyanine green),
25 mg/vial, was withdrawn from sale for
reasons of safety or effectiveness.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that IC-GREEN (indocyanine
green), 25 mg/vial, was not withdrawn
for reasons of safety or effectiveness.
The petitioner has identified no data or
other information suggesting that this
drug product was withdrawn for reasons
of safety or effectiveness. We have
carefully reviewed our files for records
concerning the withdrawal of IC-GREEN
(indocyanine green), 25 mg/vial, from
sale. We have also independently
evaluated relevant literature and data
for possible postmarketing adverse
events. We have found no information
that would indicate that this drug
product was withdrawn from sale for
reasons of safety or effectiveness.
Accordingly, the Agency will
continue to list IC-GREEN (indocyanine
green), 25 mg/vial, in the ‘‘Discontinued
Drug Product List’’ section of the Orange
Book. The ‘‘Discontinued Drug Product
List’’ delineates, among other items,
drug products that have been
discontinued from marketing for reasons
other than safety or effectiveness.
ANDAs that refer to this drug product
or these drug products may be approved
by the Agency as long as they meet all
other legal and regulatory requirements
for the approval of ANDAs. If FDA
determines that labeling for this drug
product should be revised to meet
current standards, the Agency will
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advise ANDA applicants to submit such
labeling.
Dated: November 7, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation,
and International Affairs.
[FR Doc. 2024–27090 Filed 11–19–24; 8:45 am]
BILLING CODE 4164–01–P
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.
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:
SUMMARY:
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
E:\FR\FM\20NON1.SGM
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Federal Register / Vol. 89, No. 224 / Wednesday, November 20, 2024 / Notices
khammond on DSK9W7S144PROD with NOTICES
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
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the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/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
debarments@fda.hhs.gov.
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
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(CDAD clinical trial) on behalf of a
sponsor (a pharmaceutical company).
Mr. Montalvo Villa, along with his coconspirators, 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 coconspirators, 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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Federal Register / Vol. 89, No. 224 / Wednesday, November 20, 2024 / Notices
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 onsite 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
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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
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Frm 00089
Fmt 4703
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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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–0150]
Revocation of Two Authorizations of
Emergency Use of In Vitro Diagnostic
Devices for Detection and/or Diagnosis
of COVID–19; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
revocation of the Emergency Use
Authorizations (EUAs) (the
Authorizations) issued to Cue Health,
Inc., for the Cue COVID–19 Test, and
Cue COVID–19 Test for Home and Over
The Counter (OTC) Use. FDA revoked
the Authorizations under the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) as requested by the Authorization
holder. The revocations, which include
an explanation of the reasons for each
revocation, are reprinted at the end of
this document.
DATES: The revocation of the
Authorizations for the Cue Health, Inc.’s
Cue COVID–19 Test, and Cue COVID–19
Test for Home and Over The Counter
(OTC) Use are effective as of October 9,
2024.
ADDRESSES: Submit written requests for
a single copy of the revocations to the
Office of Policy, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring,
MD 20993–0002. Send one selfaddressed adhesive label to assist that
office in processing your request or
include a fax number to which the
revocations may be sent. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the revocations.
FOR FURTHER INFORMATION CONTACT: Kim
Sapsford-Medintz, Office of Product
Evaluation and Quality, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 3216,
Silver Spring, MD 20993–0002, 301–
796–0311 (this is not a toll-free
number).
SUMMARY:
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]]>Agencies
[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.
-----------------------------------------------------------------------
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
