Analay Rico: Final Debarment Order, 37546-37548 [2023-12249]
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37546
Federal Register / Vol. 88, No. 110 / Thursday, June 8, 2023 / Notices
will provide a response within 2
business days.
Dated: June 5, 2023.
Alison Barkoff,
Acting Administrator and Assistant Secretary
for Aging.
[FR Doc. 2023–12248 Filed 6–7–23; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–2688]
Analay Rico: Final Debarment Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
issuing an order under the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) permanently debarring Analay Rico
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.
Rico was convicted of a felony under
Federal law for conduct relating to the
development or approval, including the
process for development or approval, of
any drug product under the FD&C Act.
Analay Rico was given notice of the
proposed permanent debarment and
was given an opportunity to request a
hearing to show why she should not be
debarred. As of March 3, 2023 (30 days
after receipt of the notice), Ms. Rico had
not responded. Ms. Rico’s failure to
respond and request a hearing within
the prescribed timeframe constitutes a
waiver of her right to a hearing
concerning this action.
DATES: This order is applicable June 8,
2023.
ADDRESSES: Any application by Analay
Rico 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 as follows:
SUMMARY:
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,
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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–2022–N–
2688. 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. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your application and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
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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 Compliance
and Enforcement, Office of Policy,
Compliance, and Enforcement, Office of
Regulatory Affairs, 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
(21 U.S.C. 335a(a)(2)(A)) 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 under the FD&C Act. On
October 18, 2022, Ms. Rico 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
accepted her plea of guilty and entered
judgment against her for one count of
conspiracy to commit mail fraud and
wire fraud in violation of 18 U.S.C.
1349.
The factual basis for this conviction is
as follows: As contained in the
Information, entered into the docket on
March 16, 2021, and the Factual Proffer
in support of Ms. Rico’s guilty plea,
entered into the docket on August 8,
2022, both from her case, Ms. Rico was
a clinical research coordinator
employed at Tellus Clinical Research,
Inc. (Tellus). Tellus was a medical
research clinic that conducted clinical
trials on behalf of pharmaceutical
company sponsors. Among the clinical
research trials conducted by Tellus were
two different studies of an
investigational drug intended to treat
opioid dependency sponsored by
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Federal Register / Vol. 88, No. 110 / Thursday, June 8, 2023 / Notices
Sponsor 1 and managed by Contract
Research Organization (CRO) 1 (the
opioid dependency trials); two studies
of an investigational drug intended to
treat irritable bowel syndrome in female
patients sponsored by Sponsor 2 and by
CRO 2 (the IBS trials); and one study of
an investigational injectable drug
intended to treat diabetic nephropathy
sponsored by Sponsor 3 and managed
by CRO 3 (the diabetes trial). One of Ms.
Rico’s co-conspirators was the clinical
investigator hired by the sponsors and/
or the CROs for each of these five
studies (the Studies). Ms. Rico served as
a study coordinator for the Studies. In
that role, she was responsible for
administering procedures to subjects in
the Studies and preparing honest and
accurate written records, including
records known as ‘‘case histories,’’
describing the participation of the
subjects in the Studies.
Ms. Rico and her co-conspirators
caused false information to be entered
in subject case histories to make it
appear that subjects had, among other
things, satisfied eligibility criteria to
participate in the Studies, provided
informed consent to participate in the
Studies, received physical
examinations, received or been
administered the investigational drug
for the Studies, and received payments
for visits to Tellus for the Studies when,
in truth and in fact, Ms. Rico knew that
such events had not occurred.
For example, on or about March 12,
2014, Ms. Rico initialed case history
documentation in the first Opioid
dependency study for subject, N.F., the
mother of one of Ms. Rico’s coconspirators, wherein Ms. Rico
indicated falsely that N.F. was eligible
to participate in the study, provided a
urine sample that tested positive for
opiates and buprenorphine, received
study medication from one of Ms. Rico’s
co-conspirators, and that another coconspirator witnessed N.F. receive the
study medication. Ms. Rico knew that
N.F. was not eligible to participate in
the study, had not provided a urine
sample that tested positive for opiates or
buprenorphine, and had not received
any study medication, and these
representations were false. In addition,
on or about June 9, 2015, Ms. Rico
initialed case history documentation for
subject G.C., falsely representing that
G.C. was a study subject participating in
the second IBS study, that G.C. had
visited Tellus, that Ms. Rico had
obtained G.C.’s urine and blood for
analysis as required by the protocol
governing IBS Study 2, that Ms. Rico
had performed an electrocardiogram on
G.C., and that Ms. Rico had dispensed
IBS Study 2 medication to G.C. In truth,
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Ms. Rico knew that G.C. was not
participating in the second IBS study
and that these representations were
false.
Furthermore, Ms. Rico knew that
subjects in the IBS trials were required
to make daily phone calls to an ‘‘ediary’’ system (a toll-free number
maintained by a third party) and report
their personal experience with the study
drug. In furtherance of the conspiracy,
Ms. Rico and her co-conspirators
knowingly placed telephone calls to the
e-diary system, using the subjects’
individual PIN numbers, for purposes of
reporting fabricated data on behalf of
subjects in the IBS studies. Ms. Rico and
her co-conspirators placed these
fraudulent telephone calls on behalf of
more than 10 subjects in the IBS trials.
Ms. Rico also participated in falsifying
and fabricating data in connection with
the diabetes trial. For example, on or
about November 20, 2015, Ms. Rico
initialed case history documentation for
subject S.D. in the diabetes trial, falsely
representing that she witnessed one of
her co-conspirators dispense the study
drug to subject S.D. at Tellus. In truth,
Ms. Rico knew these representations
were false. For her work as a clinical
research coordinator at Tellus and for
her participation in the conspiracy, Ms.
Rico received approximately $240,000.
In 2016, FDA conducted a regulatory
inspection of Tellus relating to
allegations of fraudulent and fabricated
data submitted in the IBS trials. For the
purpose of preventing FDA investigators
from learning the truth about fabricated
data at Tellus, Ms. Rico contacted
certain individuals enrolled as subjects
in the IBS trials and instructed them to
lie to FDA investigators regarding their
participation in the IBS trials. Among
other things, Ms. Rico instructed
subjects to falsely represent to FDA
investigators that they had participated
in an IBS study at Tellus, received
physical examinations and
electrocardiograms, and met with a
doctor who matched the physical
description of one of Ms. Rico’s coconspirators.
As a result of this conviction, FDA
sent Ms. Rico by certified mail on
January 20, 2023, 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.
Rico was convicted, as set forth in
section 306(l)(1) of the FD&C Act, 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 under the
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37547
FD&C Act. The proposal also offered
Ms. Rico 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
an election not to use the opportunity
for a hearing and a waiver of any
contentions concerning this action. Ms.
Rico received the proposal on February
1, 2023. She did not request a hearing
within the timeframe prescribed by
regulation and has, therefore, waived
her opportunity for a hearing and any
contentions concerning her debarment
(21 CFR part 12).
II. Findings and Order
Therefore, the Assistant
Commissioner, Office of Human and
Animal Food Operations, under section
306(a)(2)(A) of the FD&C Act, under
authority delegated to the Assistant
Commissioner, finds that Ms. Rico 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 under the FD&C Act.
As a result of the foregoing finding,
Ms. Rico 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 the services of Ms. Rico in any
capacity 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. Rico 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. Rico during
her period of debarment, other than in
connection with an audit under 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))).
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37548
Federal Register / Vol. 88, No. 110 / Thursday, June 8, 2023 / Notices
Dated: June 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–12249 Filed 6–7–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–P–0120]
Determination That BUSPAR
(Buspirone Hydrochloride) Capsules, 5
Milligrams, 7.5 Milligrams, 10
Milligrams, and 15 Milligrams, Were
Not Withdrawn From Sale for Reasons
of Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we)
has determined that BUSPAR
(buspirone hydrochloride) capsules, 5
milligrams (mg), 7.5 mg, 10 mg, and 15
mg, were not withdrawn from sale for
reasons of safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDA) for buspirone
hydrochloride capsules, 5 mg, 7.5 mg,
10 mg, and 15 mg, if all other legal and
regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT:
Caitlin Callahan, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6248,
Silver Spring, MD 20993–0002, 240–
402–4318, Caitlin.Callahan@
fda.hhs.gov.
SUMMARY:
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
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SUPPLEMENTARY INFORMATION:
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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).
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.
BUSPAR (buspirone hydrochloride)
capsules, 5 mg, 7.5 mg, 10 mg, and 15
mg, are the subject of NDA 021190, held
by Bristol Myers Squibb Co., and
initially approved on December 20,
2000. BUSPAR is indicated for the
management of anxiety disorders or the
short-term relief of the symptoms of
anxiety.
In correspondence dated December
28, 2012, Bristol Myers Squibb Co.
requested withdrawal of NDA 021190
for BUSPAR (buspirone hydrochloride).
In the Federal Register of December 5,
2014 (79 FR 72186), FDA announced
that it was withdrawing approval of
NDA 021190, effective January 5, 2015.
Epic Pharma, LLC submitted a citizen
petition dated January 10, 2023 (Docket
No. FDA–2023–P–0120), under 21 CFR
10.30, requesting that the Agency
determine whether BUSPAR (buspirone
hydrochloride) capsules, 5 mg, 7.5 mg,
10 mg, and 15 mg, were 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 BUSPAR (buspirone
hydrochloride) capsules, 5 mg, 7.5 mg,
10 mg, and 15 mg, were not withdrawn
for reasons of safety or effectiveness.
The petitioner has identified no data or
other information suggesting that
BUSPAR (buspirone hydrochloride)
capsules, 5 mg, 7.5 mg, 10 mg, and 15
mg, were withdrawn for reasons of
safety or effectiveness. We have
carefully reviewed our files for records
concerning the withdrawal of BUSPAR
(buspirone hydrochloride) capsules, 5
mg, 7.5 mg, 10 mg, and 15 mg, from
sale. We have also independently
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evaluated relevant literature and data
for possible postmarketing adverse
events. We have reviewed the available
evidence and determined that this drug
product was not withdrawn from sale
for reasons of safety or effectiveness.1
Accordingly, the Agency will
continue to list BUSPAR (buspirone
hydrochloride) capsules, 5 mg, 7.5 mg,
10 mg, and 15 mg, 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 BUSPAR
(buspirone hydrochloride) capsules, 5
mg, 7.5 mg, 10 mg, and 15 mg, 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 advise ANDA applicants to submit
such labeling.
Dated: June 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–12247 Filed 6–7–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–2136]
Advisory Committee; Antimicrobial
Drugs Advisory Committee; Renewal
AGENCY:
Food and Drug Administration,
HHS.
Notice; renewal of Federal
advisory committee.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
renewal of the Antimicrobial Drugs
Advisory Committee by the
Commissioner of Food and Drugs (the
Commissioner). The Commissioner has
determined that it is in the public
interest to renew the Antimicrobial
Drugs Advisory Committee for an
additional 2 years beyond the charter
expiration date. The new charter will be
in effect until the October 7, 2024,
expiration date.
SUMMARY:
1 FDA previously determined that BUSPAR
(buspirone hydrochloride) tablets, 5 mg, 10 mg, 15
mg, and 30 mg, approved under NDA 018731 and
held by Bristol Myers Squibb Co. Pharmaceutical
Research Institute, were not withdrawn from sale
for reasons of safety or effectiveness. See 75 FR
64310 (October 19, 2010), 81 FR 61220 (September
6, 2016).
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]]>Agencies
[Federal Register Volume 88, Number 110 (Thursday, June 8, 2023)]
[Notices]
[Pages 37546-37548]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-12249]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-2688]
Analay Rico: Final Debarment Order
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is issuing an
order under the Federal Food, Drug, and Cosmetic Act (FD&C Act)
permanently debarring Analay Rico 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. Rico was
convicted of a felony under Federal law for conduct relating to the
development or approval, including the process for development or
approval, of any drug product under the FD&C Act. Analay Rico was given
notice of the proposed permanent debarment and was given an opportunity
to request a hearing to show why she should not be debarred. As of
March 3, 2023 (30 days after receipt of the notice), Ms. Rico had not
responded. Ms. Rico's failure to respond and request a hearing within
the prescribed timeframe constitutes a waiver of her right to a hearing
concerning this action.
DATES: This order is applicable June 8, 2023.
ADDRESSES: Any application by Analay Rico 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 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-
2022-N-2688. 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. If you do not wish your name and contact information to be made
publicly available, you can provide this information on the cover sheet
and not in the body of your application and you must identify this
information as ``confidential.'' 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 Compliance
and Enforcement, Office of Policy, Compliance, and Enforcement, Office
of Regulatory Affairs, Food and Drug Administration, 240-402-8743 or
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(a)(2)(A) of the FD&C Act (21 U.S.C. 335a(a)(2)(A))
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 under the FD&C Act. On October 18, 2022, Ms. Rico 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 accepted her plea of guilty and entered judgment against her for
one count of conspiracy to commit mail fraud and wire fraud in
violation of 18 U.S.C. 1349.
The factual basis for this conviction is as follows: As contained
in the Information, entered into the docket on March 16, 2021, and the
Factual Proffer in support of Ms. Rico's guilty plea, entered into the
docket on August 8, 2022, both from her case, Ms. Rico was a clinical
research coordinator employed at Tellus Clinical Research, Inc.
(Tellus). Tellus was a medical research clinic that conducted clinical
trials on behalf of pharmaceutical company sponsors. Among the clinical
research trials conducted by Tellus were two different studies of an
investigational drug intended to treat opioid dependency sponsored by
[[Page 37547]]
Sponsor 1 and managed by Contract Research Organization (CRO) 1 (the
opioid dependency trials); two studies of an investigational drug
intended to treat irritable bowel syndrome in female patients sponsored
by Sponsor 2 and by CRO 2 (the IBS trials); and one study of an
investigational injectable drug intended to treat diabetic nephropathy
sponsored by Sponsor 3 and managed by CRO 3 (the diabetes trial). One
of Ms. Rico's co-conspirators was the clinical investigator hired by
the sponsors and/or the CROs for each of these five studies (the
Studies). Ms. Rico served as a study coordinator for the Studies. In
that role, she was responsible for administering procedures to subjects
in the Studies and preparing honest and accurate written records,
including records known as ``case histories,'' describing the
participation of the subjects in the Studies.
Ms. Rico and her co-conspirators caused false information to be
entered in subject case histories to make it appear that subjects had,
among other things, satisfied eligibility criteria to participate in
the Studies, provided informed consent to participate in the Studies,
received physical examinations, received or been administered the
investigational drug for the Studies, and received payments for visits
to Tellus for the Studies when, in truth and in fact, Ms. Rico knew
that such events had not occurred.
For example, on or about March 12, 2014, Ms. Rico initialed case
history documentation in the first Opioid dependency study for subject,
N.F., the mother of one of Ms. Rico's co-conspirators, wherein Ms. Rico
indicated falsely that N.F. was eligible to participate in the study,
provided a urine sample that tested positive for opiates and
buprenorphine, received study medication from one of Ms. Rico's co-
conspirators, and that another co-conspirator witnessed N.F. receive
the study medication. Ms. Rico knew that N.F. was not eligible to
participate in the study, had not provided a urine sample that tested
positive for opiates or buprenorphine, and had not received any study
medication, and these representations were false. In addition, on or
about June 9, 2015, Ms. Rico initialed case history documentation for
subject G.C., falsely representing that G.C. was a study subject
participating in the second IBS study, that G.C. had visited Tellus,
that Ms. Rico had obtained G.C.'s urine and blood for analysis as
required by the protocol governing IBS Study 2, that Ms. Rico had
performed an electrocardiogram on G.C., and that Ms. Rico had dispensed
IBS Study 2 medication to G.C. In truth, Ms. Rico knew that G.C. was
not participating in the second IBS study and that these
representations were false.
Furthermore, Ms. Rico knew that subjects in the IBS trials were
required to make daily phone calls to an ``e-diary'' system (a toll-
free number maintained by a third party) and report their personal
experience with the study drug. In furtherance of the conspiracy, Ms.
Rico and her co-conspirators knowingly placed telephone calls to the e-
diary system, using the subjects' individual PIN numbers, for purposes
of reporting fabricated data on behalf of subjects in the IBS studies.
Ms. Rico and her co-conspirators placed these fraudulent telephone
calls on behalf of more than 10 subjects in the IBS trials. Ms. Rico
also participated in falsifying and fabricating data in connection with
the diabetes trial. For example, on or about November 20, 2015, Ms.
Rico initialed case history documentation for subject S.D. in the
diabetes trial, falsely representing that she witnessed one of her co-
conspirators dispense the study drug to subject S.D. at Tellus. In
truth, Ms. Rico knew these representations were false. For her work as
a clinical research coordinator at Tellus and for her participation in
the conspiracy, Ms. Rico received approximately $240,000.
In 2016, FDA conducted a regulatory inspection of Tellus relating
to allegations of fraudulent and fabricated data submitted in the IBS
trials. For the purpose of preventing FDA investigators from learning
the truth about fabricated data at Tellus, Ms. Rico contacted certain
individuals enrolled as subjects in the IBS trials and instructed them
to lie to FDA investigators regarding their participation in the IBS
trials. Among other things, Ms. Rico instructed subjects to falsely
represent to FDA investigators that they had participated in an IBS
study at Tellus, received physical examinations and electrocardiograms,
and met with a doctor who matched the physical description of one of
Ms. Rico's co-conspirators.
As a result of this conviction, FDA sent Ms. Rico by certified mail
on January 20, 2023, 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. Rico was
convicted, as set forth in section 306(l)(1) of the FD&C Act, 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 under the FD&C Act. The proposal also offered Ms. Rico 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 an election not to use
the opportunity for a hearing and a waiver of any contentions
concerning this action. Ms. Rico received the proposal on February 1,
2023. She did not request a hearing within the timeframe prescribed by
regulation and has, therefore, waived her opportunity for a hearing and
any contentions concerning her debarment (21 CFR part 12).
II. Findings and Order
Therefore, the Assistant Commissioner, Office of Human and Animal
Food Operations, under section 306(a)(2)(A) of the FD&C Act, under
authority delegated to the Assistant Commissioner, finds that Ms. Rico
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 under the FD&C Act.
As a result of the foregoing finding, Ms. Rico 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 the services of Ms. Rico in any capacity 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. Rico 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. Rico during her period of debarment, other than in connection with
an audit under 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))).
[[Page 37548]]
Dated: June 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-12249 Filed 6-7-23; 8:45 am]
BILLING CODE 4164-01-P
