Notice2024-11546
Jessica Palacio; Denial of Hearing; 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
May 28, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is denying a request for a hearing submitted by Andrew S. Feldman, on behalf of Jessica Palacio (Palacio), and is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Palacio 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 Palacio 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. FDA provided notice to Palacio of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Palacio submitted a request for hearing but failed to file with the Agency information and analyses sufficient to create a basis for a hearing.
Full Text
<html>
<head>
<title>Federal Register, Volume 89 Issue 103 (Tuesday, May 28, 2024)</title>
</head>
<body><pre>
[Federal Register Volume 89, Number 103 (Tuesday, May 28, 2024)]
[Notices]
[Pages 46125-46127]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-11546]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-0201]
Jessica Palacio; Denial of Hearing; Final Debarment Order
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is denying a
request for a hearing submitted by Andrew S. Feldman, on behalf of
Jessica Palacio (Palacio), and is issuing an order under the Federal
Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Palacio
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 Palacio 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.
FDA provided notice to Palacio of the proposed debarment and an
opportunity to request a hearing within the timeframe prescribed by
regulation. Palacio submitted a request for hearing but failed to file
with the Agency information and analyses sufficient to create a basis
for a hearing.
DATES: The order is applicable May 28, 2024.
ADDRESSES: Any application for termination of debarment by Palacio
under section 306(d) of the FD&C Act (21 U.S.C. 335a(d)) (application)
may be submitted as follows:
Electronic Submissions
<bullet> 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>.
<bullet> 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
Submit written/paper submissions as follows:
<bullet> 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.
<bullet> 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-
2023-N-0201. An application will be placed in the docket and, unless
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.
<bullet> 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: Karen Fikes, Office of Scientific
Integrity, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 1, Rm. 4232, Silver Spring, MD 20993, 301-796-9603.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(a)(2)(A) of the FD&C Act mandates permanent debarment
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.
On January 12, 2023, following a jury trial, the U.S. District Court
for the Southern District of Florida entered
[[Page 46126]]
a judgment against Palacio for one count of false statements in
violation of 18 U.S.C. 1001(a)(2).
A grand jury returned a two-count indictment on May 12, 2021,
against Palacio, the study coordinator, for clinical trials from about
2013 to 2015 at Unlimited Medical Research, LLC (Unlimited). The
indictment charged Palacio with conspiring to commit wire fraud, in
violation of 18 U.S.C. 1349 and making a false statement to FDA, in
violation of 18 U.S.C. 1001(a)(2). On September 13, 2022, the jury
found Palacio guilty of both charges. However, on September 15, 2022,
the court granted Palacio's motion for acquittal with respect to the
conspiracy. On January 12, 2023, the court entered a criminal judgment
against Palacio for false statements in violation of 18 U.S.C.
1001(a)(2) and sentenced Palacio to 36 months imprisonment.
By letter dated August 18, 2023, FDA's Office of Regulatory Affairs
(ORA) notified Palacio of a proposal to issue an order of permanent
debarment (Notice). As explained in the Notice, Palacio's conviction
stemmed, in part, from a statement made in a signed affidavit to FDA
investigators during the Agency's investigation into allegations of
irregularities in data submitted by Unlimited. Unlimited previously
contracted with Parexel International, a contract research organization
that the sponsor company, GlaxoSmithKline (GSK), a global biopharma
company, hired to conduct a clinical trial, known as the Vestri Study,
to study certain asthma drugs in pediatric subjects aged 4 to 11 years.
GSK reported allegations of irregular data to FDA related to certain
records created by Unlimited that documented the participation of
certain pediatric subjects. As study coordinator at Unlimited, Palacio
would have, among other responsibilities, helped to ensure the study
protocol was followed. Therefore, as part of the investigation, FDA
questioned Palacio regarding the irregularities. Specifically,
inspectors inquired about the screening visit of a specific subject
called D.H., including records indicating Palacio performed a screening
visit and records indicating the subject had been in school at the time
of the purported screening. Palacio then signed an affidavit, on April
25, 2017, stating, ``I can confirm that the Screening/Visit 1 was
performed by myself and Dr. Villaman-Bencosme.'' As explained in the
Notice, this statement was false in that Palacio knew at that time that
D.H. had not participated in the clinical trial; therefore, she had not
screened D.H. for the Vestri study. The signed affidavit was part of
the evidence offered at trial leading to Palacio's conviction for
making false statements to FDA in violation of 18 U.S.C. 1001(a)(2).
The Notice explained that the proposed permanent debarment of
Palacio is based on her Federal felony conviction for making false
statements to FDA and that the conduct serving as the basis for that
conviction relates to the development or approval, including the
process for development or approval, of any drug product. The Notice
also informed Palacio of an opportunity for her to request a hearing
under section 306(i) of the FD&C Act and part 12 (21 CFR part 12).
In response to the Notice, Palacio submitted a timely request for a
hearing, which included a notice of appearance and request for an
extension to submit materials in support of the hearing request.
Following two extensions to submit supporting materials, which were
both granted, on December 4, 2023, Palacio submitted a response
entitled ``Memorandum in Support of a Request for a Hearing
(Memorandum).'' Palacio's Memorandum included several claims and
multiple documents challenging whether she is subject to permanent
debarment. Specifically, Palacio challenges whether her conviction
relates to the development or approval, including the process for
development or approval, of any drug product.
Under the authority delegated to him by the Commissioner of Food
and Drugs, the Director, Office of Scientific Integrity (OSI Director)
has considered Palacio's request for a hearing. Hearings are granted
only if there is a genuine and substantial issue of fact. A request for
a hearing may not rest upon mere allegations or denials but must
present specific facts showing that there is a genuine and substantial
issue of fact that justifies a hearing. Hearings will not be granted on
issues of policy or law, on mere allegations, denials or general
descriptions of positions and contentions, or on data and information
insufficient to justify the factual determination urged (see Sec.
12.24(b) (21 CFR 12.24(b))).\1\
---------------------------------------------------------------------------
\1\ Palacio's Memorandum references her request for a hearing
pursuant to the standard identified in 21 CFR part 16 as opposed to
the standard outlined in Sec. 12.24. In the Notice, ORA explained
that her proposed debarment and the request for a hearing are
addressed under the regulations outlined in part 12. Consequently,
FDA applies the standard described in Sec. 12.24 to Palacio's
hearing request.
---------------------------------------------------------------------------
II. Argument in Support of a Hearing
Under section 306(a)(2)(A) of the FD&C Act, an individual convicted
of a Federal felony for conduct relating to the development or
approval, including the process for development or approval, of any
drug product is subject to permanent debarment. The relevant factual
issues are whether Palacio was, in fact, convicted of a Federal felony
and whether the basis of that conviction relates to the development or
approval, including the process for development or approval, of any
drug product.
Palacio does not dispute that a court convicted her of a Federal
felony under 18 U.S.C. 1001(a)(2). In fact, in her Memorandum, Palacio
concedes that her conviction is a fact not in dispute. However, Palacio
challenges whether the conduct underlying her conviction relates to the
development and approval, including the process for development and
approval, of a drug. In her Memorandum, Palacio offers two central
claims to support her argument: (1) material facts exist, which would
determine whether she qualifies for permanent debarment under section
306(a)(2)(A) of the FD&C Act; and (2) nine prior permanent debarments
are factually distinguishable from her proposed debarment, as they
relate to false statements made ``while a clinical trial or similar
study was ongoing.''
Section 306(a)(2)(A) of the FD&C Act specifically provides for
permanent and mandatory debarment of individuals convicted of a felony
under Federal law for conduct related to the development or approval,
including the process for development or approval, of any drug product.
If the language of the statute is clear, there is no need to look
outside the statute to its legislative history in order to ascertain
the statute's meaning (Chamber of Commerce of the United States v.
Whiting, 563 U.S. 582, 599 (2011)). Likewise, the Supreme Court has
repeatedly held that the language in the FD&C Act should be construed
in a manner consistent with its overall public health purpose. The FD&C
Act is given ``liberal construction consistent with the Act's
overriding purpose to protect public health . . .'' (United States v.
Article of Drug Bacto-Unidisk, 394 U.S. 784, 798 (1969)). The Supreme
Court has addressed the definition of ``relating to'' in the context of
other statutory authorities. Specifically, the Supreme Court stated
that ``relating to'' expressed a broad legislative purpose and defined
it as ``. . . to stand in some relation; to have bearing or concern; to
pertain; refer; to bring into association with or connection with.''
(Morales v. Trans World Airlines, Inc., 504 U.S. 374, 383 (1992)
(citing Black's Law Dictionary 1158 (5th ed. 1979))). When applying
this definition to ``reasonably related'' in the context of FDA-
regulated drug patents, the Supreme Court declined to read the
requirement
[[Page 46127]]
narrowly. Rather, an activity that is ``appropriate to include in a
submission to the FDA . . . is `reasonably related' to the `development
and submission of information under . . . Federal law'' (Merck KGaA v.
Integra Lifesciences I, Ltd., 545 U.S. 193, 207 (2005)).
In a previous action requiring mandatory debarment under section
306(a)(2)(A) of the FD&C Act for conduct relating to the development or
approval, including the process for development or approval, of any
drug product, FDA stated that ``the statutory language `relating to the
development or approval' . . . by definition, encompasses all things
that are logically connected with the development or approval of a drug
product.'' (Atul Shah; Denial of Hearing; Final Debarment Order, (59 FR
62399, December 5, 1994), (citing Webster's Collegiate Dictionary,
Merriam-Webster Inc., Springfield, MA, 1990, ``relate''); see also Ray
Nathan; Denial of Hearing; Final Debarment Order, (76 FR 48869 at
48870, August 9, 2011), (affirming the Shah definition of ``relates
to,'' and going further to define ``develop'' . . . ``to explore the
possibilities of'' and ``to make suitable for commercial * * *
purposes.'' (see ``Merriam-Webster's Collegiate Dictionary,'' 10th
Edition (2002))).\2\
---------------------------------------------------------------------------
\2\ See also, The Drug Development Process [verbar] FDA.
(<a href="https://www.fda.gov/patients/learn-about-drug-and-device-approvals/drug-development-process">https://www.fda.gov/patients/learn-about-drug-and-device-approvals/drug-development-process</a>).
---------------------------------------------------------------------------
Palacio's felony conviction is related to the development and
approval, including the process for development and approval, of a
drug. The trial established that Palacio held the role of clinical
trial coordinator at the clinical trial site, Unlimited, which
contracted to conduct a clinical trial to study certain asthma drugs in
pediatric subjects between the ages of 4 and 11 years. As ORA explained
in the Notice, drug sponsors, like GSK, submit clinical trial data in
support of drug product applications for review and approval by FDA,
and the Agency relies upon the integrity of the data and information in
the applications to determine whether a drug meets required safety and
effectiveness standards. The basis for Palacio's Federal felony
conviction for false statements in a signed affidavit is regarding
conduct in her role as clinical trial coordinator. Specifically, in her
signed affidavit Palacio ``represented . . . that she had performed a
screening visit for D.H. in the Study, when in truth and in fact, and
as [Palacio] then and there well knew, she had not performed a
screening for D.H. . .'' Palacio's false statements about her role in
the conduct of a clinical trial related to the development or approval,
including the process for development or approval, of any drug product.
Palacio's role and statements regarding her role pertaining to the
Vestri Study, a clinical study meant to inform GSK's submission to FDA,
are logically connected to the development or approval of a drug
product. Palacio's Memorandum does not provide any material facts
capable of overcoming the clear language in section 306(a)(2)(A) of the
FD&C Act and the logical connection of her conduct to the development
or approval, including the process for development or approval, of any
drug product. Therefore, Palacio has failed to raise a genuine and
substantial issue of fact warranting a hearing to determine whether she
is subject to permanent debarment. Accordingly, the OSI Director need
not address Palacio's other arguments, including her efforts to
distinguish her own conduct from that of other debarred individuals.
III. Findings and Order
Therefore, the OSI Director, under section 306(a)(2)(A) of the FD&C
Act and authority delegated to him by the Commissioner of Food and
Drugs, finds that Palacio 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.
As a result of the foregoing findings, Palacio is permanently
debarred from providing services in any capacity to a person with an
approved or pending drug product application under sections 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), effective May 28,
2024 (see 21 U.S.C. 335a(c)(1)(B) and (c)(2)(A)(ii) and 21 U.S.C.
321(dd)). Any person with an approved or pending drug product
application, who knowingly uses the services of Palacio, in any
capacity during her period of 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 Palacio, during her period of debarment, provides services in any
capacity to a person with an approved or pending drug product
application, 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 applications submitted by or with the
assistance of Palacio during her period of debarment (section
306(c)(1)(B) of the FD&C Act).
Dated: May 21, 2024.
George M. Warren,
Director, Office of Scientific Integrity.
[FR Doc. 2024-11546 Filed 5-24-24; 8:45 am]
BILLING CODE 4164-01-P
</pre></body>
</html>Indexed from Federal Register on May 28, 2024.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.