Enhancing Drug Safety

User-fee legislation will require more testing and data disclosure to prevent unsafe drug use.
Sep 02, 2007
Volume 31, Issue 9

Jill Wechsler
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

Push for more appropriations
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").

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.

In Washington This Month
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.

Managing risks

lorem ipsum