Notice2023-13135
Daylen Diaz: Final Debarment Order
Primary source
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Published
June 21, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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 Daylen Diaz 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 Daylen Diaz 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. Daylen Diaz 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 February 26, 2023 (30 days after receipt of the notice), Ms. Diaz had not responded. Ms. Diaz' 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 118 (Wednesday, June 21, 2023)</title>
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[Federal Register Volume 88, Number 118 (Wednesday, June 21, 2023)]
[Notices]
[Pages 40275-40276]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-13135]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-2687]
Daylen Diaz: 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 Daylen Diaz 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 Daylen Diaz 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. Daylen Diaz 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
February 26, 2023 (30 days after receipt of the notice), Ms. Diaz had
not responded. Ms. Diaz' 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 21, 2023.
ADDRESSES: Any application by Daylen Diaz 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-2687. Received applications will be placed in the docket and,
except for 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, 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
<a href="/cdn-cgi/l/email-protection#c5a1a0a7a4b7a8a0abb1b685a3a1a4ebadadb6eba2aab3"><span class="__cf_email__" data-cfemail="8de9e8efecffe0e8e3f9fecdebe9eca3e5e5fea3eae2fb">[email protected]</span></a>.
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. Diaz 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. Diaz' guilty plea, entered into the
docket on August 8, 2022, both from her case, Ms. Diaz was a research
assistant and assistant study coordinator employed at Tellus Clinical
Research, Inc. (Tellus). Tellus was a medical research clinic that
conducted clinical trials on behalf of pharmaceutical company sponsors.
Sponsor 1 was a drug manufacturer that developed drugs for commercial
distribution in the United States. Contract Research Organization 1
(CRO 1) was an organization that hired clinical investigators and
managed clinical trials for sponsors. On or about December 23, 2013,
CRO 1 entered into a contract with Tellus and one of Ms.
[[Page 40276]]
Diaz' co-conspirators in which Tellus and Ms. Diaz' co-conspirator
agreed to serve as study site and clinical investigator, respectively,
for a clinical trial initiated by sponsor 1 (IBS study 1) designed to
evaluate a drug intended to treat irritable bowel syndrome in female
patients. On or about September 5, 2014, CRO 1 entered into a contract
to conduct a second clinical trial initiated by sponsor 1 (IBS study
2), which evaluated the same drug in the same population over the
course of 52 weeks. Sponsor 2 was a drug manufacturer that developed
drugs for commercial distribution in the United States. On or about
January 5, 2015, sponsor 2 entered into a contract with Tellus and one
of Ms. Diaz' co-conspirators in which they agreed to serve as study
site and clinical investigator, respectively, for a clinical trial
initiated by sponsor 2 (the diabetes study). The diabetes study was
designed to evaluate the safety and efficacy of an experimental
injectable drug intended to treat subjects with kidney damage from
diabetes.
Ms. Diaz served as an assistant study coordinator for IBS study 1,
IBS study 2, and the diabetes study (collectively, the ``Studies''). As
an assistant study coordinator for the Studies, Ms. Diaz 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 subjects in the
Studies. Ms. Diaz along with her co-conspirators caused false
information to be entered in subject case histories to make it appear
that subjects had, among other things, satisfied the 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 when, in truth and in fact, and
as Ms. Diaz well knew, such events had not occurred. For example, on or
about April 6, 2015, Ms. Diaz initialed case history documentation for
a study subject, K.L., falsely representing that K.L. was a study
subject participating in IBS study 2, that K.L. visited Tellus, that
Ms. Diaz obtained K.L.'s urine and blood for analysis as required by
the protocol governing IBS study 2, that Ms. Diaz had performed an
electrocardiogram on K.L., and that Ms. Diaz dispensed IBS study 2
medication to K.L. In truth and in fact, Ms. Diaz knew that K.L. was
not participating in IBS study 2 and these representations were false.
In addition, Ms. Diaz knew that IBS study 2 subjects were required to
make daily phone calls to an ``e-diary'' (a toll-free number maintained
by a third party) and report their personal experience with the IBS
study 2 drug. In furtherance of the conspiracy, Ms. Diaz along with 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 IBS study 2 subjects. Ms. Diaz along with
her co-conspirators placed these fraudulent telephone calls on behalf
of more than 10 subjects in IBS study 2.
Ms. Diaz also participated in falsifying and fabricating data in
connection with the diabetes study. For example, on May 13, 2015, Ms.
Diaz initialed case history documentation for subject S.D., falsely
representing that S.D. has visited Tellus, that Ms. Diaz trained S.D.
on the appropriate handling of the investigational drug, and that S.D.
self-administered the study drug by injection. In truth and in fact,
Ms. Diaz knew that S.D. had not visited Tellus or received the study
drug, and these representations were false. Ms. Diaz, along with her
co-conspirators, also enrolled subjects in the diabetes study who did
not meet the eligibility criteria or participate in the trial. Further,
Ms. Diaz observed her co-conspirator dispense diabetes study medication
into the garbage, but falsely represent in case history documentation
that the medication had been administered to study subject S.D.
As a result of this conviction, FDA sent Ms. Diaz 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. Diaz 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. Diaz 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. Diaz received the proposal on January 27,
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. Diaz
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. Diaz 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. Diaz 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. Diaz 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 (21 U.S.C.
335b(a)(7))). In addition, FDA will not accept or review any
abbreviated new drug application from Ms. Diaz 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 (21 U.S.C.
335a(c)(1)(B))). Note that, for purposes of sections 306 and 307 of the
FD&C Act (21 U.S.C. 335a and 335b), 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: June 14, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-13135 Filed 6-20-23; 8:45 am]
BILLING CODE 4164-01-P
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