Notice2023-12249
Analay Rico: Final Debarment Order
Primary source
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Published
June 8, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 110 (Thursday, June 8, 2023)</title>
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[Federal Register Volume 88, Number 110 (Thursday, June 8, 2023)]
[Notices]
[Pages 37546-37548]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-12249]
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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.
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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
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. An application
submitted electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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
<a href="/cdn-cgi/l/email-protection#cca8a9aeadbea1a9a2b8bf8caaa8ade2a4a4bfe2aba3ba"><span class="__cf_email__" data-cfemail="5d39383f3c2f303833292e1d3b393c7335352e733a322b">[email protected]</span></a>.
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
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