[Federal Register Volume 86, Number 223 (Tuesday, November 23, 2021)]
[Notices]
[Pages 66566-66567]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-25589]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0405]
Maytee Lledo: Final Debarment Order
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is issuing an order
under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently
debarring Maytee Lledo 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. Lledo was convicted of a felony
under Federal law for conduct that relates to the development or
approval, including the process for development or approval, of any
drug product under the FD&C Act. Ms. Lledo was given notice of the
proposed permanent debarment and an opportunity to request a hearing to
show why she should not be debarred within the timeframe prescribed by
regulation. Ms. Lledo has not responded to the notice. Ms. Lledo'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 November 23, 2021.
ADDRESSES: Submit applications for termination of debarment to the
Dockets Management Staff, Food and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, or at https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Jaime Espinosa, Division of
Enforcement (ELEM-4029), Office of Strategic Planning and Operational
Policy, Office of Regulatory Affairs, Food and Drug Administration,
12420 Parklawn Dr., Rockville, MD 20857, 240-402-8743, or at
[email protected].
SUPPLEMENTARY INFORMATION:
[[Page 66567]]
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 for development or approval, of any
drug product under the FD&C Act. On April 16, 2021, in the U.S.
District Court for the Southern District of Florida, Miami Division, a
judgment of conviction was entered against Ms. Maytee Lledo, after her
plea of guilty to one count of Conspiracy to Commit Wire Fraud in
violation of 18 U.S.C. 1349, a felony offense under Federal law.
The factual basis for this conviction is as follows: As contained
in the Information, entered into the docket on August 31, 2020, and the
Factual Proffer in Support of Ms. Lledo's guilty plea, entered into the
docket on February 5, 2021, both from her case, Ms. Lledo was a
receptionist at Sacred Heart Medical Office P.A., a private medical
practice, in Florida. That medical practice primarily served a
pediatric population. From about September 2013 through June 2016, Ms.
Lledo and others conspired to unlawfully enrich themselves by making
materially false representations about clinical trials, fabricating
data and the participation of subjects in those clinical trials,
concealing from FDA, sponsors, and contract research organizations the
fact that the data and participation of subjects had been fabricated,
and inducing sponsors and contract research organizations to pay money
for Ms. Lledo and her co-conspirators' own benefit. Specifically, one
of Ms. Lledo's co-conspirators entered into a contract with a Contract
Research Organization (CRO) retained by a drug manufacturer (Sponsor)
to hire clinical investigators and to manage clinical trials. Ms.
Lledo's co-conspirator entered into a contract with the CRO to conduct
a study at Unlimited Medical Research site in return for payment. The
study was for an investigational drug intended to treat pediatric
asthma in children between the ages of 4 and 11 years. Her co-
conspirators were responsible for complying with the study protocol,
including administering study drug to subjects in the study and
preparing written records, known as case histories, which documented
the participation of subjects in the study.
Ms. Lledo participated in a scheme to defraud the Sponsor by
fabricating the data and participation of subjects in the clinical
trial in a variety of ways. Ms. Lledo and her co-conspirators falsified
medical records to portray persons as legitimate study subjects when
they were not. In addition, her co-conspirators made it appear as
though pediatric subjects made scheduled visits to Unlimited Medical
Research when they had not; made it appear as though subjects had taken
the study drug as required when they had not; and made it appear that
the study subjects had received checks as payment when they had not. In
addition, study subjects were required to make daily phone calls to an
``e-diary'' system and report their daily drug usage and experience
with the study drug. As part of the conspiracy, Ms. Lledo placed
thousands of telephone calls to the e-diary system, using falsely
obtained PIN numbers to access the system, for purposes of reporting
fabricated data on behalf of purportedly legitimate study subjects. Ms.
Lledo entered this fabricated information in the e-diary system for at
least 11 study subjects.
Based on this conviction, FDA sent Ms. Lledo by certified mail on
July 27, 2021, 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. Lledo 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 a drug
product under the FD&C Act. The proposal also offered Ms. Lledo 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 file a timely request for a hearing would constitute an
election not to use the opportunity for a hearing and a waiver of any
contentions concerning this action. Ms. Lledo received the proposal on
August 2, 2021. 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. Lledo
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 a drug product under the FD&C Act.
As a result of the foregoing finding, Ms. Lledo 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 (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 in any capacity the services of Ms. Lledo 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. Lledo 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.
Lledo 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 the FD&C Act (21 U.S.C. 355, 360b, or
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))).
Any application by Ms. Lledo for special termination of debarment
under section 306(d)(4) of the FD&C Act should be identified with
Docket No. FDA-2021-N-0405 and sent to the Dockets Management Staff
(see ADDRESSES). The public availability of information in these
submissions is governed by 21 CFR 10.20.
Publicly available submissions will be placed in the docket and
will be viewable at https://www.regulations.gov or at the Dockets
Management Staff (see ADDRESSES) between 9 a.m. and 4 p.m., Monday
through Friday, 240-402-7500.
Dated: November 17, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-25589 Filed 11-22-21; 8:45 am]
BILLING CODE 4164-01-P