[Federal Register Volume 88, Number 70 (Wednesday, April 12, 2023)]
[Notices]
[Pages 22043-22045]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-07670]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-2515]


Olga L. Torres: Final Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C 
Act) permanently debarring Olga L. Torres 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. Torres 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. Ms. Torres 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 
January 20, 2023 (30 days after receipt of the notice), Ms. Torres had 
not responded. Ms. Torres' 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 April 12, 2023.

ADDRESSES: Any application by Olga L. Torres 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

    [ssquf] 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.
    [ssquf] 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

    [ssquf] 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.
    [ssquf] 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-2515. Received applications will be placed in the docket and, 
except for

[[Page 22044]]

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.
    [ssquf] 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. 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, at 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 for 
development or approval, of any drug product under the FD&C Act. On 
September 30, 2022, Ms. Olga L. Torres 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 
obstruction of agency proceeding in violation of 18 U.S.C. 1505.
    The factual basis for this conviction is as follows: as contained 
in the information, entered into the docket on October 28, 2021, and 
the Factual Proffer in support of her guilty plea, entered into the 
docket on January 13, 2022, Ms. Torres co-owned a business called 
Unlimited Medical Research, LLC (Unlimited Medical Research) that 
conducted clinical trials on behalf of pharmaceutical company sponsors. 
On or around October 25, 2013, on behalf of Unlimited Medical Research, 
Ms. Torres signed a contract with a contract research organization 
retained by a drug manufacturer (Sponsor) to conduct a clinical trial 
(Study) initiated by the Sponsor. The clinical trial was designed to 
study the safety and efficacy of an investigational asthma medication 
in children between the ages of 4 and 11 with persistent asthma. Dr. 
Yvelice Villaman-Bencosme was a licensed medical doctor who had been 
retained by Unlimited Medical Research to serve as the clinical 
investigator for the Study.
    On or about February 6, 2017, Ms. Torres learned that FDA 
investigators intended to conduct a regulatory inspection of Dr. 
Villaman-Bencosme in her capacity as the clinical investigator for the 
Study at Unlimited Medical Research. Ms. Torres also learned that, as 
part of the inspection, FDA investigators would review records prepared 
and maintained by Unlimited Medical Research concerning the study. The 
FDA regulatory inspection began on or about February 6, 2017, and 
continued until on or about April 28, 2017. In or around February 2017, 
as part of the inspection, Ms. Torres was interviewed by FDA 
investigators. On or about February 24, 2017, while the regulatory 
inspection remained ongoing, Ms. Torres reviewed and signed an 
affidavit which summarized her interview. In that affidavit, Ms. Torres 
made a number of false statements for purposes of falsely portraying to 
FDA investigators that the Study had been conducted legitimately and 
honestly, when in fact it had not. For example, Ms. Torres falsely 
represented in her signed affidavit that subjects were seen at 
Unlimited Medical Research and that medical records prepared and 
maintained by Unlimited Medical Research, which had been provided to 
the FDA investigators during the course of the inspection, and which 
purported to document the participation of subjects in the Study, were 
accurate and complete. In fact, Unlimited Medical Research employees 
falsified case histories to portray persons as legitimate study 
subjects who attended scheduled study visits at Unlimited Medical 
Research, when in fact such persons were not subjects participating in 
the Study. Ms. Torres knew these statements were dishonest and were 
made with the specific intent to conceal the truth about the Study from 
the FDA investigators and thereby prevent FDA from recommending further 
regulatory enforcement action against Unlimited Medical Research or its 
staff.
    Based on this conviction, FDA sent Ms. Torres by certified mail on 
December 9, 2022, 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. Torres 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 for development or approval, of any 
drug product under the FD&C Act. The proposal also offered Ms. Torres 
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. Torres received the proposal on December 
21, 2022. 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. 
Torres 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.

[[Page 22045]]

    As a result of the foregoing finding, Ms. Torres is permanently 
debarred from providing services in any capacity to a person with an 
approved or pending drug product application, applicable as of the date 
of this order (see DATES) (see section 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. Torres 
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. Torres 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. Torres 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 this 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: April 7, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-07670 Filed 4-11-23; 8:45 am]
BILLING CODE 4164-01-P