Jessica Palacio v. U.S. Food and Drug Administration

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April 13, 2026 Get Citation Alerts Download PDF Add Note

Jessica Palacio v. U.S. Food and Drug Administration

Court of Appeals for the Eleventh Circuit

• Citations: None known
• Docket Number: 24-12446

• Nature of Suit: NEW

• Opinion

• Authorities (3)

• Cited By (0)

• Summaries (0)

• Similar Cases (1.2K)

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Combined Opinion

USCA11 Case: 24-12446 Document: 51-1 Date Filed: 04/13/2026 Page: 1 of 5

FOR PUBLICATION

In the
United States Court of Appeals
For the Eleventh Circuit

No. 24-12446

JESSICA PALACIO,
Petitioner,
versus

U.S. FOOD AND DRUG ADMINISTRATION,
Respondent.

Petition for Review of a Decision of the
Food and Drug Administration
Agency No. FDA-2023-N-0201

Before WILLIAM PRYOR, Chief Judge, and BRASHER and ABUDU, Cir-
cuit Judges.
WILLIAM PRYOR, Chief Judge:
This petition for review requires us to decide whether a
Food and Drug Administration debarment order was contrary to
USCA11 Case: 24-12446 Document: 51-1 Date Filed: 04/13/2026 Page: 2 of 5

2 Opinion of the Court 24-12446

law or arbitrary and capricious. See 5 U.S.C. § 706 (2)(A). Jessica Pa-
lacio was convicted of making a false statement to the Administra-
tion during an investigation. The Administration then debarred her
under a statute requiring permanent debarment for individuals
“convicted of a felony under Federal law for conduct . . . relating
to the development or approval, including the process for develop-
ment or approval, of any drug product.” 21 U.S.C. § 335a(a)(2). Be-
cause the Administration’s debarment order was required by law,
we deny the petition for review.
I. BACKGROUND
Jessica Palacio worked as a clinical trial coordinator for Un-
limited Medical Research, LLC, from 2013 to 2015. Unlimited con-
ducted a clinical trial for a pharmaceutical company to evaluate an
asthma drug for pediatric use. The company terminated the clinical
trial in 2015 and alerted the Food and Drug Administration to ir-
regularities in the data, including a record stating that Palacio
screened a child while school attendance records established that
the child was in school.
The Administration initiated an investigation in early 2017.
Palacio signed an affidavit confirming that she conducted the
screening of the child. Her sworn statement was false because she
knew the child did not participate in the clinical trial. A jury found
Palacio guilty of one count of making a false statement to the Ad-
ministration, see 18 U.S.C. § 1001 (a)(2), and the district court sen-
tenced her to 36 months of imprisonment.
USCA11 Case: 24-12446 Document: 51-1 Date Filed: 04/13/2026 Page: 3 of 5

24-12446 Opinion of the Court 3

The Administration permanently debarred Palacio from
providing services relating to drug applications based on her false-
statement conviction. Jessica Palacio; Denial of Hearing; Final De-
barment Order, 89 Fed. Reg. 46,125 (May 28, 2024). The Admin-
istration invoked a statute that requires it to permanently debar in-
dividuals “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.” 21 U.S.C.
§ 335a(a)(2). It explained that the phrase “‘relating to the develop-
ment or approval’ . . . encompasses all things that are logically con-
nected with the development or approval of a drug product,”
which necessarily includes investigations. And it declined to “ad-
dress Palacio’s . . . efforts to distinguish her own conduct from that
of other debarred individuals” because Palacio’s conduct satisfied
the “clear language” of the statute.
II. STANDARDS OF REVIEW
Under the Administrative Procedure Act, we must “hold un-
lawful and set aside agency action, findings, and conclusions” that
are “arbitrary, capricious, an abuse of discretion, or otherwise not
in accordance with law.” 5 U.S.C. § 706 (2). We “exercise [our] in-
dependent judgment in deciding whether an agency has acted
within its statutory authority.” Loper Bright Enters. v. Raimondo, 144
S. Ct. 2244, 2273 (2024). But “[a]rbitrary-and-capricious review is
deferential—an agency’s decisions need only be reasonable and
reasonably explained.” Fla. Agency for Health Care Admin. v. Adm’r
for Ctrs. for Medicare & Medicaid Servs., 161 F.4th 765, 786 (11th Cir.
2025) (citation and internal quotation marks omitted).
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4 Opinion of the Court 24-12446

III. DISCUSSION
The Administration must permanently debar individuals it
“finds . . . ha[ve] 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.” 21
U.S.C. § 335a(a)(2). To interpret this law, “we begin with the stat-
utory text, and proceed from the understanding that unless other-
wise defined, statutory terms are generally interpreted in accord-
ance with their ordinary meaning” at “the time of enactment.” Re-
gions Bank v. Legal Outsource PA, 936 F.3d 1184, 1190 (11th Cir. 2019)
(citation and internal quotation marks omitted). The ordinary
meaning of the text resolves this appeal.
Palacio’s false statement relates to the drug development
and approval process because it impeded an investigation into the
integrity of that very process. “Relate to” means “[t]o stand in some
relation; to have bearing or concern; to pertain; refer; to bring into
association with or connection with.” Relate, BLACK’S LAW
DICTIONARY (6th ed. 1990); see also Relate, WEBSTER’S THIRD NEW
INT’L DICTIONARY 1916 (1993) (“to be in relationship: have refer-
ence”); Morales v. Trans World Airlines, Inc., 504 U.S. 374, 384 (1992)
(defining “relates to” as “ha[ving] a connection with or reference
to” (citation and internal quotation marks omitted)). The ordinary
meaning of “relating to” “is a broad one.” Morales, 504 U.S. at 383
(internal quotation marks omitted). Indeed, “[i]t is hard . . . to think
of a more capacious term to use in defining the coverage of a pro-
vision.” AQuate II LLC v. Myers, 100 F.4th 1316, 1321 (11th Cir.
2024).
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24-12446 Opinion of the Court 5

Palacio argues that her false-statement conviction does not
relate to drug development or approval because she did not make
the false statement until April 2017, “almost [two] years after” the
pharmaceutical company terminated the clinical trial. But the ordi-
nary meaning of “relating to” contains neither a temporal nor a
causal limitation. And section 335a covers conduct relating to “the
process for development or approval,” not just the development or
approval of a specific drug. 21 U.S.C. § 335a(a)(2)(A) (emphasis
added).
She also argues her debarment is arbitrary and capricious be-
cause the false statements underlying other debarments were made
“while a clinical trial or similar study was ongoing.” But even if typ-
ical debarments occur while clinical trials are ongoing, Palacio’s
conduct satisfied the plain language of the statute, so her debar-
ment was not arbitrary or capricious. See BBX Cap. v. FDIC, 956 F.3d
1304, 1317 (11th Cir. 2020).
IV. CONCLUSION
We DENY the petition for review.