It happens often in drug development: a drugmaker submits an NDA, an expert panel gives the okay, everyone expects an approval--and then the FDA delivers a not-approvable letter. In fact, it's happened several times this year, most recently to Schering-Plough with the rejection of sugammadex, but also to Merck with Cordaptive, Eisai, Vanda Pharmaceuticals and UCB. Inevitably the drug developer releases the news, but only the company ever sees the rejection letter.
That's because the FDA is required by law to keep information on unapproved therapies secret. Drug companies have certainly improved on their transparency. They're required to list all ongoing trial and the results of those trials, but the FDA lags in this area. It was just last month that the agency made a clearer distinction between approvable and not-approvable letters; companies had been asking for the change since 1997. "Many of us at FDA would like to see greater transparency," John Jenkins, director of the FDA's Office of New Drugs, noted in Forbes. "But we're restricted by the current statutory limitations."
- read the Forbes article