[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]


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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

     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