The Food and Drug Administration has reached agreement with the drug companies it regulates on steps that might speed review of new medications, in return for tens of millions in new industry fees.
The industry has long funded a significant portion of the FDA's drug review work. But for the first time, the agreement would allow some of that money to go to improved safety monitoring of new drugs - allowing the FDA to eventually double its number of staffers who oversee the risks of newly sold therapies.
But drug safety advocates say some of the proposal is worrisome. In wake of a dozen drugs pulled off the market because of dangers in recent years, critics say the FDA already is approving drugs too fast and doesn't adequately monitor problems that can arise when new ones hit the market.
Drug companies have paid millions in user fees that help fund FDA's review of their products since 1993, under a law called the Prescription Drug User Fee Act, or PDUFA. At the same time, it is costing more to review ever more complex drugs - and companies are discovering fewer of them, meaning the FDA is getting fewer industry payments. The result is a shortfall that reached $30 million this year.