American Association for Cancer Research



                                                                                                    JUNE 2010


Prescription Drug User Fee Act intended to expedite drug approval process

Ensuring new regulatory science to support personalized medicine and 21st century medicine will be a primary focus as the U.S. Food and Drug Administration (FDA) prepares for the next reauthorization of the Prescription Drug User Fee Act (PDUFA).

PDUFA authorizes the FDA to collect fees from manufacturers to help offset the cost of reviewing new applications to market drugs and biologics. PDUFA fees, supplemented by dollars appropriated by Congress, support specified activities that are critical for conducting thorough and timely review of drug applications. The revenue provided by the fees has accounted for an increasing proportion of FDA funding since PDUFA was first enacted in 1992. In fiscal year 1994, the first year FDA reported PDUFA revenue, the fees contributed 9.7 percent of the human drug program’s budget; today, that number is 65 percent or more.

There have been four consecutive PDUFA programs over the past 17 years; the current legislative authority for PDUFA IV, reauthorized in 2007 by the FDA Amendments Act, will expire in September 2012. The FDA Amendments Act of 2007 also included provisions for medical devices, pediatric research and pharmaceuticals, and priority review of treatments for tropical disease, as well as creating Reagan-Udall Foundation and establishing risk evaluation and mitigation strategies.

Throughout the summer and fall, FDA will hold negotiations with industry and meet with patient and consumer groups to assess of the overall performance of the PDUFA IV program thus far and to determine what aspects of PDUFA should continue or be changed to further strengthen and improve the program.

“I would say we still don’t have a sophisticated drug safety system, but we’re on the way to building one,” said Dr. Janet Woodcock, director of the FDA Center for Drug Evaluation and Research, at the most recent April 12 public meeting.

Stakeholders in the biomedical research community have also begun to discuss common issues and interests to bring to the discussion around reauthorization.    

After negotiations are concluded, FDA will publish the meeting minutes as well as the administration's proposed recommendations for reauthorization and establish a docket to obtain public input on those recommendations.

The administration's final proposed recommendations will be submitted to Congress in January of 2012 so that lawmakers can begin to craft a bill that can be passed before PDUFA expires in September.


Read more from the June Edition of the AACR Cancer Policy Monitor: