chapter  8
18 Pages

The Influence of the Prescription Drug User Fee Act on the Approval Process

WithProcess Marc J. Scheineson, Esq.

SUMMARY OF THE PRESCRIPTION DRUG USER FEE ACT OF 1992 (PDUFA I) (OCT. 1, 1993, TO SEPT. 30, 1997) Nature of the Deal In 1991, when Dr. David Kessler sat in his new desk chair in his downtown Washington, D.C., office, shortly after being nominated and confirmed as the Commissioner of Food and Drugs, he asked himself the recurring question, “How can so few employees with such a limited federal budget perform all the responsibilities expected of us?” At that time, the U.S. Food and Drug Administration (FDA) had fewer than 8000 employees in 25 districts across the United States. Its budget was just over $850 million. Its jurisdiction included inspecting the entire domestic processed food supply, sampling and inspecting imported products under its jurisdiction, reviewing and approving the export of regulated products to foreign countries, inspecting every product manufacturing establishment every 2 years and the country’s entire blood supply, reviewing and approving applications and labeling and promotion for new prescription drugs, generic drugs, animal drugs, biologics, vaccines, medical devices, completing over-the-counter drug regulations, conducting surveillance on those approved products, soliciting and investigating adverse reaction reports, supervising the labeling and sale of medical foods, infant formulas, teas, dietary supplements, cosmetics, regulating every product that emits radiation (including light bulbs, cellular telephones, lasers, microwave ovens, television sets), inspecting the kitchens of commercial aircraft and cruise ships, and, with whatever time was left, making sure that product advertising was truthful, fairly balanced, and not false or misleading. This was a relatively paltry budget, especially when compared to the $2 billion budget of the U.S. Department of Agriculture to support hundreds of thousands of employees with a tenth of the jurisdiction. FDA states that it regulates products that comprise $0.25 of every consumer dollar spent. In reality, it regulates nearly one quarter of the American economy. On top of all this pressure, Dr. Kessler was bombarded with industry and congressional pressure to streamline and expedite the review of promising new life-saving prescription drugs and biologics. Those approvals were averaging 2 to 3 years following submission of complete new drug applications (NDAs) and what are now called Biologics Licensing Applications (BLAs). Nonpriority applications for “me-too” drugs could take 5 years or more to preview and approve.