George Mason University Antonin Scalia Law School

C-IP2 Statement on Interactions between Courts and the FDA

a gavel lying on a table in front of booksCourts have recently questioned Food and Drug Administration (FDA) determinations. The FDA is the administrative agency whose job is to evaluate scientific data to determine if a drug is safe and effective enough to be approved, and post-approval, to continue to evaluate such data to determine if a drug should remain available.  

Generally, the most expensive part of bringing a drug to market is the clinical trials necessary to obtain FDA approval. Courts substituting their evaluations of scientific data and overruling the FDA would harm innovation, future pharmaceutical research, and funding. While courts can and should review agency policies and decisions under the administrative procedures act, courts should not substitute their opinions for expert agency decisions.