As expected, legislation to reauthorize the Prescription Drug User Fee Act (PDUFA IV) has been expanded with a host of provisions
designed to shape drug development and ensure the safe use of medications. With PDUFA IV, Congress will provide the US Food
and Drug Administration with more tools and legal authority to monitor and mitigate drug risks and also will impose new requirements
on manufacturers for assessing, preventing, and correcting safety problems.
This broad bill implements an FDA–industry user-fee agreement issued in January 2007, as well as a similar user-fee plan for
medical devices. Because the fees have to be finalized by Sept. 30, 2007, the legislation also provides a vehicle for Congress
to retain incentives that were set to expire. The incentives encourage manufacturers to study pediatric uses of drugs and
devices. In the drug-safety area, the bill gives FDA authority to require postapproval clinical trials and to revise product
labels within a set timeframe. Manufacturers will have to disclose more information about study results and ongoing clinical
trials and list various pharmacovigilance activities to ensure the appropriate use of risky medications. The legislation provides
more funding for FDA oversight of postmarket drug use and for expanding the agency's information systems that track adverse
events and detect emerging safety problems.
Raising fees for services
The final legislation boosts the user fees paid by pharmaceutical companies even more than the amount negotiated by industry
and FDA last year. The PDUFA IV agreement raised fees to nearly $400 million for 2008 to adjust for inflation and the increased
cost of overseeing the drug-development and review process in an efficient and timely fashion. Furthermore, an additional
fee program seeks to bolster FDA review of drug advertising on television. Although some parties feel that FDA already is
overly dependent on user fees, the agency will need all the added fee revenues the legislators provide because its appropriated
funding is barely keeping up with inflation (see sidebar, "Push for more appropriations").
Push for more appropriations
An important change in the PDUFA program permits the use of fee revenues to support drug-safety oversight and assessment throughout
a product's life cycle—not just during the first two or three years after product approval, as currently allowed. The increased
payments will support additional staffers in FDA's Office of Surveillance and Epidemiology in the Center for Drug Evaluation
and Research, and enhance the safety office's role in evaluating postapproval risk information and labeling changes.
One specific PDUFA project is to improve FDA's system for assessing proposed product names, an initiative that aims to reduce
medication errors from look-alike and sound-alike names. The program calls for sponsors to submit proposed proprietary names
during Phase III testing or earlier so that FDA will have time to meet a 180-day review timeframe without delaying application
approval. Added resources will enable FDA to issue guidance documents about how manufacturers should select and evaluate product
names and propose such names to the agency. In the future, FDA plans to shift responsibility for testing proposed proprietary
names to manufacturers, a process that will be tested in a pilot program.
In Washington This Month