US Generic Makers' Terms For Accepting User Fees

The US Food and Drug Administration's willingness to pull resourcesfrom the Office of Generic Drugs is a primary reason for its being able to meet the Prescription Drug User Fee Act's performance goals, the National Association of Pharmaceutical Manufacturers has said in written testimony to the House health and environment subcommittee, which is discussing FDA reform.

Inordinate approval delays for Abbreviated New Drug Applications are the generic industry's biggest hurdle today, said the NAPM. ANDAs do not contain the volumes of clinical evidence required for NDA approval, yet the FDA reviews and approves NDAs at almost twice the speed of ANDAs, it noted.

The Administration's proposal, drawn up without any industry input, would keep the OGD's fiscal 1998 budget at 1997's $35.5 million, with $13 million coming from user fees; an effective $13 million cut. Critical to NAPM acceptance of user fees is FDA and Administration commitment to a maintenance of effort to which regulatory fees would be added to speed ANDA approvals; review times could be cut from an average of 33 months, the NAPM said. Otherwise, it strongly opposes any form of generic user fees.