FDA's Final Performance Report Under PDUFA

The US Food and Drug Administration's workload of applications for newdrugs and biologics has grown 50% since 1992, FDA lead deputy commissioner Michael Friedman has told the Food and Drug Law Institute's annual education seminar. Also, the quantity of regulated imports has nearly doubled since the 1990s began, while the number of inspectors has grown only slightly.

In fiscal 1997, the FDA approved a record 416 generic applications and has taken on new public health responsibilities, only some of them with extra funding, he said. But through improved management and hard work, it has performed at a record-setting place, its review of new drugs and biologics continuing at a 96% on-time performance. Drugs and biologics' median time to approval has dropped steadily, and will be 12 months for the 96 cohort for both standard and priority drugs. The FDA says over 11 million Americans received a newly-marketed drug in 1997 that would have not been available until 1998 without the Prescription Drug User Fee Act, at a cost of just $8 per patient.

Overall performance, measured by approved products, has risen 17% on average in the last few years, but he questioned how this can be sustained with constrained resources and without compromising high public health standards. Congress, the Administration and the public expect more from the FDA, he said; industry also has the highest expectations.