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

── Jessica Palacio v. U.S. Food and Drug Administration ── Court: Court of Appeals for the Eleventh Circuit Date: April 13, 2026 Category: NEW 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-