[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