Ivette Maria Portela Martinez: Final Debarment Order, 91406-91408 [2024-26912]
Download as PDF
<![CDATA[
ddrumheller on DSK120RN23PROD with NOTICES1
91406
Federal Register / Vol. 89, No. 223 / Tuesday, November 19, 2024 / Notices
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the listed drug was withdrawn from sale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).
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a listed drug was withdrawn from sale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time after the drug has been withdrawn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.
HYDROCORTONE (hydrocortisone
sodium phosphate) injection, EQ 50 mg
base/mL, is the subject of NDA 012052,
held by Merck & Co., Inc., and initially
approved on June 8, 1960.
HYDROCORTONE (hydrocortisone
sodium phosphate) injection, EQ 50 mg
base/mL, is synthetic glucocorticoid for
use as an anti-inflammatory or
immunosuppressant agent.
The indications for glucocorticoid
drugs, including HYDROCORTONE
(hydrocortisone sodium phosphate)
injection, EQ 50 mg base/mL (Merck
Sharpe & Dohme (now Merck & Co.,
Inc.); NDA 012052) were reviewed for
efficacy under the Drug Efficacy Study
Implementation program. Under this
program, which was implemented in
response to the 1962 amendments to the
FD&C Act requiring demonstration of
effectiveness (Kefauver-Harris
Amendments of 1962 (Pub. L. 87–781)),
the National Academy of SciencesNational Research Council (NAS–NRC)
studied about 4,000 drug formulations
to assess the efficacy of the drug
products. Upon consideration of the
findings and recommendations of the
NAS–NRC, FDA set forth in the Federal
Register its conclusions and assessment
of whether and under what
circumstances the reviewed drug
products are considered ‘‘effective’’ for
use as required by the FD&C Act. In the
Federal Register of February 19, 1972
(37 FR 3775), FDA announced that
preparations containing hydrocortisone
sodium phosphate are effective or
probably effective for parenteral use by
the appropriate route of administration.
FDA published a subsequent notice in
the Federal Register of March 1, 1977
(42 FR 11893), in which the Agency set
forth the indications that it found to be
effective for certain drug products,
including for HYDROCORTONE
(hydrocortisone sodium phosphate)
injection, EQ 50 mg base/mL (NDA
012052). The March 1, 1977, notice
announced FDA was prepared to
VerDate Sep<11>2014
17:42 Nov 18, 2024
Jkt 265001
approve NDAs and supplements to
previously approved NDAs under the
conditions described in the notice,
including the condition that the revised
labeling include only the indications for
which the drug was classified as
effective set forth in that notice (42 FR
11893 at 11894–5).
HYDROCORTONE (hydrocortisone
sodium phosphate) injection, EQ 50 mg
base/mL, is currently listed in the
‘‘Discontinued Drug Product List’’
section of the Orange Book. In a letter
dated April 4, 2003, Merck & Co., Inc.,
notified FDA that HYDROCORTONE
(hydrocortisone sodium phosphate)
injection, EQ 50 mg base/mL, was
discontinued effective September 20,
2002. In the same letter, Merck & Co.,
Inc., also requested withdrawal of NDA
012052 for HYDROCORTONE
(hydrocortisone sodium phosphate), and
FDA moved the drug product to the
‘‘Discontinued Drug Product List’’
section of the Orange Book. In the
Federal Register of May 5, 2004 (69 FR
25124), FDA announced that it was
withdrawing approval of NDA 012052,
effective June 4, 2004.
Hyman, Phelps & McNamara, P.C.,
submitted an initial citizen petition
dated September 21, 2020 (Docket No.
FDA–2020–P–1991) as well as a second
citizen petition dated August 25, 2021
(Docket No. FDA–2021–P–0940), under
21 CFR 10.30, requesting that the
Agency determine whether
HYDROCORTONE (hydrocortisone
sodium phosphate) injection, EQ 50 mg
base/mL, was withdrawn from sale for
reasons of safety or effectiveness.
After considering the citizen petitions
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that HYDROCORTONE
(hydrocortisone sodium phosphate)
injection, EQ 50 mg base/mL, was not
withdrawn for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
suggesting that HYDROCORTONE
(hydrocortisone sodium phosphate)
injection, EQ 50 mg base/mL, was
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of
HYDROCORTONE (hydrocortisone
sodium phosphate) injection, EQ 50 mg
base/mL, 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.
PO 00000
Frm 00094
Fmt 4703
Sfmt 4703
Accordingly, the Agency will
continue to list HYDROCORTONE
(hydrocortisone sodium phosphate)
injection, EQ 50 mg base/mL, 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 HYDROCORTONE (hydrocortisone
sodium phosphate) injection, EQ 50 mg
base/mL, may be approved by the
Agency if 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 advise ANDA applicants to
submit such labeling.
Dated: November 7, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation,
and International Affairs.
[FR Doc. 2024–26916 Filed 11–18–24; 8:45 am]
BILLING CODE 4164–01–P
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.
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.
SUMMARY:
E:\FR\FM\19NON1.SGM
19NON1
Federal Register / Vol. 89, No. 223 / Tuesday, November 19, 2024 / Notices
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:
DATES:
ddrumheller on DSK120RN23PROD with NOTICES1
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
VerDate Sep<11>2014
17:42 Nov 18, 2024
Jkt 265001
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-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, 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
PO 00000
Frm 00095
Fmt 4703
Sfmt 4703
91407
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 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. Ms.
Portela Martinez participated with two
other co-conspirators with falsifying and
fabricating study documents. Ms.
Portela Martinez and her coconspirators 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 coconspirators, 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
E:\FR\FM\19NON1.SGM
19NON1
ddrumheller on DSK120RN23PROD with NOTICES1
91408
Federal Register / Vol. 89, No. 223 / Tuesday, November 19, 2024 / Notices
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 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
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
VerDate Sep<11>2014
17:42 Nov 18, 2024
Jkt 265001
regulation and has, therefore, waived
her opportunity for a hearing and
waived any contentions concerning her
debarment (21 CFR part 12).
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
II. Findings and Order
[Docket No. FDA–2024–N–1178]
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))).
Kevin Sheng Hsiang Fang: Final
Debarment Order
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
PO 00000
Frm 00096
Fmt 4703
Sfmt 4703
Food and Drug Administration
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) debarring
Kevin Sheng Hsiang Fang for a period
of 5 years from importing articles of
food or offering such articles for
importation into the United States. FDA
bases this order on a finding that Mr.
Fang was convicted of a felony count
under Federal law for conduct relating
to the importation into the United States
of an article of food. Mr. Fang was given
notice of the proposed debarment and
an opportunity to request a hearing
within the timeframe prescribed by
regulation. As of July 1, 2024 (30 days
after receipt of the notice), Mr. Fang has
not responded. Mr. Fang’s failure to
respond and request a hearing
constitutes a waiver of Mr. Fang’s right
to a hearing concerning this matter.
DATES: This order is applicable
November 19, 2024.
ADDRESSES: Any application by Mr.
Fang for termination of debarment
under section 306(d)(1) of the FD&C Act
(21 U.S.C. 335a(d)(1)) 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
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
E:\FR\FM\19NON1.SGM
19NON1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
