Notice2023-07670
Olga L. Torres: Final Debarment Order
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
April 12, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 70 (Wednesday, April 12, 2023)</title>
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[Federal Register Volume 88, Number 70 (Wednesday, April 12, 2023)]
[Notices]
[Pages 22043-22045]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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: <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>.
[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
<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.
[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 <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. 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 <a href="/cdn-cgi/l/email-protection#086c6d6a697a656d667c7b486e6c692660607b266f677e"><span class="__cf_email__" data-cfemail="7317161112011e161d0700331517125d1b1b005d141c05">[email protected]</span></a>.
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
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