FDA Leglislation Tackles Safety Issues

Legislation to reauthorize the Prescription Drug User Fee Act (PDUFA IV) will provide more tools and legal authority for the US Food and Drug Administration to monitor and mitigate drug risks, while also boosting user fees and extending several FDA programs. The bill, which the Congress is expected to finalize by the end of this month, implements an FDA–industry user fee agreement issued in January, and a similar plan for medical devices. Additional provisions renew incentives for manufacturers to study pediatric uses of drugs and establishes such incentives for medical devices.

To strengthen drug safety policies, the bill gives FDA authority to require postapproval clinical trials and to revise product labels within a set time-frame. Manufacturers will have to disclose more information about ongoing clinical trials and study results. There is more funding for FDA oversight of postmarket drug use and to expand the agency's information systems for tracking adverse events and for detecting emerging safety problems. Also, manufacturers of medications known to be risky will have to spell out a range of pharmacovigilance activities to inform patients and prescribers of possible dangers and to ensure appropriate product use. These initiatives should provide more timely information on emerging concerns about certain medicines, but also could drive up the cost of developing new therapies and delay access to new treatments.