FDA's Daytrana curve ball

FDA reviews of compounds posted prior to panel meetings often paint the most negative picture of efficacy and side effects, in part, the agency says, because it wants to focus attention on issues of medical or scientific uncertainty that can benefit from outside expertise. But it's altogether another thing when FDA posts negative briefing documents that don't actually reflect its views, given the instant damage done to companies and investors.

Noven Pharmaceuticals Inc. was the victim last week, losing $55.2 million (17%) of its market capitalization on Thursday because FDA posted briefing documents that senior agency officials knew at the time misrepresented the current views of the lead reviewer of the Daytrana methylphenidate patch for pediatric ADHD. The stock did not trade on Friday, when the Psychopharmacologic Drugs Advisory Committee (PDAC) unanimously recommended approval. ...