Jessica Palacio worked as a clinical trial coordinator for Unlimited Medical Research from 2013 to 2015, overseeing a clinical trial evaluating an asthma drug for pediatric use. The pharmaceutical company terminated the trial in 2015 after discovering data irregularities, including a record falsely claiming Palacio had screened a child who school attendance records showed was in class at the time. When the FDA investigated in 2017, Palacio signed a sworn affidavit confirming she had conducted the screening, knowing the statement was false because the child never participated in the trial.
The court rejected Palacio's challenge to her permanent debarment under 21 U.S.C. § 335a(a)(2), which requires the FDA to debar 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.' As Chief Judge Pryor explained, 'The ordinary meaning of "relating to" is a broad one,' and Palacio's false statement clearly met this standard because it 'impeded an investigation into the integrity of that very process.'
The panel emphasized the expansive scope of the statutory language, with Chief Judge Pryor noting that 'it is hard . . . to think of a more capacious term to use in defining the coverage of a provision' than 'relating to.' The court found that Palacio's conduct fell squarely within the statute's requirements, making her debarment mandatory rather than discretionary.
Palacio was convicted of making a false statement to the FDA under 18 U.S.C. § 1001(a)(2) and sentenced to 36 months imprisonment. The FDA subsequently issued its debarment order in May 2024, explaining that the phrase 'relating to the development or approval' encompasses 'all things that are logically connected with the development or approval of a drug product,' which necessarily includes investigations.
Palacio argued her conviction should not trigger debarment because she made the false statement in April 2017, 'almost [two] years after' the clinical trial ended. But the court firmly rejected this timing-based argument, explaining that 'the ordinary meaning of "relating to" contains neither a temporal nor a causal limitation.' Chief Judge Pryor emphasized that the statute covers conduct relating to 'the process for development or approval,' not just specific drug development projects.
The panel also dismissed Palacio's claim that her debarment was arbitrary and capricious compared to other cases where false statements were made during ongoing trials. '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,' Chief Judge Pryor wrote, joined by Circuit Judges Brasher and Abudu in the unanimous decision.
The ruling underscores the FDA's broad authority to permanently bar individuals from drug-related activities following felony convictions connected to the regulatory process. For practitioners in pharmaceutical and clinical trial law, the decision confirms that post-trial false statements to investigators can trigger the same severe consequences as misconduct during active trials.