NHC UPDATE
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Prescription Drug User Fee Act (PDUFA) -June 2010
The Prescription Drug User Fee Act (PDUFA) expires on September 30, 2012. Between now and then, the Food and Drug Administration (FDA) and Congress are required to undertake a three-phase process to reauthorize PDUFA.
PDUFA authorizes the FDA to collect fees from companies that produce certain human drug and biological products. The user fees currently fund about half of new drug review costs and have played an important role in expediting the drug approval process. PDUFA was enacted in 1992 and renewed in 1997 (PDUFA II), 2002 (PDUFA III), and 2007 (PDUFA IV). The reauthorization process for PDUFA V began with a public hearing in April.
The National Health Council will be involved with all phases of the reauthorization process, including educating the public, members of Congress, and their staff about the important role of the FDA in delivering new treatments and therapies to the market. The NHC will also be providing the patient perspective on the risk versus the benefit of new treatments.
Phase one of the reauthorization process involves public input, and requires more up-front, inclusive public consultation than under previous versions of PDUFA. In April, FDA held a stakeholders meeting at which NHC Executive Vice President and Chief Operating Officer Marc Boutin delivered comments detailing NHC recommended changes to the program.
The NHC is recommending more patient involvement at all levels of drug review. To document whether PDUFA is having an impact on the delivery of new treatments to patients, the NHC has recommended that the Government Accountability Office conduct an analysis of the impact of the risk evaluation mitigation strategies requirement under PDUFA to determine whether that process is impeding the access to safe and effective treatments, rather than speeding it up. The NHC also is calling for the development of innovative clinical trial designs.
In June, FDA will hold a PDUFA public meeting, where stakeholders from all sectors can present their PDUFA priorities to senior FDA officials. This meeting will be followed by an additional 30-day public comment period.
The second phase of reauthorization involves negotiations between FDA and industry, which lasts for 15 months. During that period of time, FDA will continue to meet monthly with patient groups and consumer advocacy groups. FDA must publish minutes from the negotiations and present initial recommendations to Congress by August 1, 2011. These recommendations will be published on the FDA website followed by another 30-day public comment period. By September 1, 2011, FDA will revise its recommendations based on these public comments.
The final phase will begin January 15, 2012, when FDA must present its final recommendations to Congress. These recommendations are non-binding, and Congress has until September 30, 2012, to reauthorize the legislation before the expiration of PDUFA IV.
