Prescription Drug User Fee Act. This act and acronym refer to the FDA funding bill that must be "reathorized" i.e., passed, every five years before the FDA can spend government funds.

The PDUFA portion refers to the authorization for the FDA to charge user fees to drug companies that ask for drug approvals. Much of the funding for FDA comes from general tax revenues, beginning in the early 90's the Congress authorized these fees to reduce the general public's cost of funding the agency.

Now this bill, which must pass before the FDA can spend government funds, has become a vehicle for the passage of special amendments that direct the agency to do specified things or fund special projects. This year it will be the vehicle for amendments related to drug safety and, possibly, advertising and other drug marketing limits.

Coalition Testimony at FDA Hearing on PDUFA, February 16, 2007