FDA Holds Public Meeting on Prescription Drug User Fee Act

The US Food and Drug Administration held a public meeting in Rockville, Maryland, on April 12, 2010, to solicit stakeholders’ comments about the Prescription Drug User Fee Act (PDUFA) program. The program authorizes user fees that help the agency ensure a predictable and efficient drug-review process. The current legislative authority for PDUFA IV, which was reauthorized in 2007 by the FDA Amendments Act, will expire in September 2012.

During the meeting, which focused on the drug-review process rather than on regulatory policy, FDA sought to gauge the public’s assessment of the PDUFA IV program’s overall performance. The agency requested comments about what aspects of PDUFA should be retained, changed, or discontinued to improve the program.

This week’s meeting was the first step in FDA’s process of evaluating PDUFA. From June 2010 through December 2010, FDA plans to hold discussions about PDUFA with industry and other public stakeholders. The agency also will consult with scientific and academic experts, healthcare professionals, and patient- and consumer-advocacy groups about the program. At the end of negotiations, FDA will publish minutes of its meetings on its website and hold a public meeting about the proposed recommendations. The agency will consider the public comments and revise recommendations as necessary.

PDUFA was first introduced in 1992 to address the agency’s staff shortage and speed review and approval times. The program authorized the agency to collect application, product, and establishment fees to help FDA increase its review staff and reduce application backlogs. In exchange for the fees, FDA has regularly agreed to meet a series of performance goals. PDUFA has helped decrease review and approval times by almost 60%. The program also has enabled FDA to approve more than 1000 new drug applications and 100 biologic license applications since 1992. In fiscal year 2008, user fees provided 65% of human drug review funding.