A unanimous panel rejected Jessica Palacio's challenge to the debarment, which followed her 2017 false affidavit to FDA investigators looking into data irregularities in a terminated pediatric asthma trial.
Palacio worked as a clinical trial coordinator for Unlimited Medical Research from 2013 to 2015, overseeing a pharmaceutical company's evaluation of the asthma drug in children. The company terminated the trial in 2015 and reported data irregularities to the FDA, including a record showing Palacio had screened a child at a time when school attendance records placed the child in class.
When the FDA investigated in 2017, Palacio signed an affidavit falsely confirming she had conducted the screening, knowing the child never participated in the trial. A jury convicted her of making a false statement under 18 U.S.C. § 1001(a)(2), and she was sentenced to 36 months in prison.
The FDA then permanently debarred her under 21 U.S.C. § 335a(a)(2), which requires debarment for individuals "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."
Chief Judge William Pryor, writing for the court, held that Palacio's false statement "relates to the drug development and approval process because it impeded an investigation into the integrity of that very process." He wrote that the ordinary meaning of "relating to" "is a broad one" and rejected her argument that the nearly two-year gap between the trial's end and her false statement placed her conduct outside the statute.
The panel, which also included Circuit Judges Andrew Brasher and Nancy Abudu, dismissed Palacio's argument that her debarment was arbitrary and capricious because prior debarments had involved false statements made while trials were ongoing. "Even if typical debarments occur while clinical trials are ongoing, Palacio's conduct satisfied the plain language of the statute, so her debarment was not arbitrary or capricious," Pryor wrote.