Doubling down on PDUFA

User fees will increase 39% in fiscal year 2003 if Congress approves the proposed terms for reauthorizing the Prescription Drug User Fee Act (PDUFA) negotiated between FDA and representatives of the biotech and pharmaceutical industries. Indeed, industry is expected to pay FDA a total of $1.2 billion over five years under PDUFA III, double the amount the agency is slated to receive from PDUFA II, which started in 1997 and expires Sept. 30.

The underlying assumptions of the proposal are not entirely clear. Thus it has not been disclosed whether the $1.2 billion is expected to come from a growing number of applications or from a further rise in user fees sometime during the five-year period...