The Food and Drug Administration’s power to make important regulatory decisions is in question after a Supreme Court decision weakening agencies’ ability to interpret ambiguous statutory measures. The ruling could mean headaches not just for the teams of lawyers and scientists at the FDA, but for the drug and device companies the agency is charged with regulating.
While the Supreme Court’s decision is not expected to have major implications on the FDA’s bread and butter task — approving individual drugs and devices — it could open up many of the agency’s regulatory efforts to legal challenge, leading to the one thing industry hates more than a bad policy: uncertainty.
“This decision is potentially going to have a destabilizing effect on the industry,” said Stacy Cline Amin, a former FDA chief counsel who now serves as a partner at Morrison & Foerster. “They won’t have the same predictability of the regulatory system that they have now.”
