And you thought the odds on new-drug approvals at the FDA were bad. Generics get the thumbs-down 96 percent of the time, according to a new report from the Inspector General. And agency review of new generics is slow, too--rather than the 180 days required by law, it's 217 days on average, more for those meds that aren't rejected outright. Those that won tentative approval saw their apps languish for an average of 300 days.
Not surprising, really, given the recent spotlight on FDA's lack of resources and staff. And going slow on the generic uptake isn't nearly so worrisome as the other problems FDA has faced because of that lack. But in any case, the IG suggested the FDA give generics makers more guidance up front so that their applications are more worthy of review the first time out.
- see the Wall Street Journal Health Blog item