Summary
The United States Court of Appeals for the Eleventh Circuit denied Jessica Palacio’s petition for review of an FDA order permanently debarring her from providing services relating to drug applications. The court held that her federal felony conviction for making a false statement during an FDA investigation related to the drug development and approval process under 21 U.S.C. § 335a(a)(2). The court also rejected her argument that the debarment was arbitrary and capricious.
Topics
Practice areas
Questions Presented
- Whether Palacio's federal felony conviction for making a false statement during an FDA investigation involved conduct relating to the development or approval, including the process for development or approval, of a drug product under 21 U.S.C. § 335a(a)(2).
- Whether the FDA's permanent debarment order was arbitrary and capricious under the Administrative Procedure Act.
Holdings
- Palacio's false statement related to the development and approval process because it impeded an investigation into the integrity of that process. The phrase "relating to" has a broad ordinary meaning and contains neither a temporal nor a causal limitation.
- The FDA's permanent debarment order was not arbitrary and capricious because Palacio's conduct satisfied the plain language of 21 U.S.C. § 335a(a)(2), even if other debarment cases involved false statements made while clinical trials were ongoing.
Key quotations
“Because the Administration’s debarment order was required by law, we deny the petition for review.” (2)
“Palacio’s false statement relates to the drug development and approval process because it impeded an investigation into the integrity of that very process.” (4)
“But the ordinary meaning of “relating to” contains neither a temporal nor a causal limitation.” (5)
“We DENY the petition for review.” (5)
Factual background
Jessica Palacio worked as a clinical trial coordinator for Unlimited Medical Research, which conducted a pediatric asthma-drug clinical trial. After irregularities were reported, the FDA investigated and Palacio signed an affidavit falsely stating that she had screened a child for the trial, even though she knew the child had not participated. A jury convicted her of making a false statement to the FDA, and the FDA permanently debarred her from providing services relating to drug applications.
Procedural history
After Palacio was convicted under 18 U.S.C. § 1001(a)(2) of making a false statement to the FDA during an investigation of a pediatric asthma-drug clinical trial, the FDA permanently debarred her from providing services relating to drug applications under 21 U.S.C. § 335a(a)(2). The Eleventh Circuit reviewed the final debarment order and denied the petition for review.