The FDA’s attitude hasn’t changed

The surprise FDA rejections this week for drugs from Gilead Sciences and Biomarin Pharmaceuticals is raising eyebrows: There’s some concern that the agency is becoming more strict, and fewer new medicines might ultimately reach the market.

But thinking that regulators have suddenly become conservative is a mistake, STAT’s Adam Feuerstein writes. The FDA has already approved 36 drugs this year, and many more are expected in the coming months. It’s simply that the Gilead and Biomarin drugs had issues that should have tempered expectations for approval. The two companies actually gambled on flawed drug applications — and it’s they, not the FDA, that are to blame for the rejections.