Drug safety sets stage for FDA legislation

April 1, 2007

Washington, D.C.-The need to reauthorize the Prescription Drug User Fee Act (PDUFA) before it expires Sept. 30, 2007, has set the stage for Congressional action on broader legislation to enhance government regulation of drug safety. Bills under consideration aim to expand Food and Drug Administration (FDA) oversight by establishing new requirements for postmarket risk assessment, for posting information on active clinical trials and the resulting study data, and for completing agreed-upon postmarketing studies.

WASHINGTON, D.C.-The need to reauthorize the Prescription Drug User Fee Act (PDUFA) before it expires Sept. 30, 2007, has set the stage for Congressional action on broader legislation to enhance government regulation of drug safety. Bills under consideration aim to expand Food and Drug Administration (FDA) oversight by establishing new requirements for postmarket risk assessment, for posting information on active clinical trials and the resulting study data, and for completing agreed-upon postmarketing studies.

Senators Edward Kennedy (D-Mass.) and Mike Enzi (R-Wyo.) have reintroduced legislation that also requires drug makers to develop a Risk Evaluation and Mitigation Strategy (REMS) for each new medicine to map out the need for special programs to manage distribution and advertising of more high-risk products. The Senate Health, Education, Pensions and Labor (HELP) Committee, which Senators Kennedy and Enzi lead, held an opening hearing on these issues last month with an eye to moving FDA user fee and drug safety legislation forward by summer. The final bill also is slated to reauthorize user fees for medical devices and to continue a program offering incentives for pharmaceutical companies to study pediatric uses of medications. The challenge will be to limit the range of proposals in any FDA legislation. Members of Congress are developing additional measures to permit broader import of drugs from other countries and to reduce obstacles to generic drug development, including generic versions of biotech therapies.

FEES TO FUND FDA

FEES FOR DTC ASSESSMENTS

A new initiative in the PDUFA IV plan establishes a separate user fee program to support FDA evaluation of direct-to-consumer prescription drug TV commercials before they go on the air. Pharmaceutical companies have agreed to pay $6.3 million to boost the number of FDA staffers that review drug advertising and promotional materials. Some members of Congress and health professionals have objected that such ad assessments should be mandatory to block the broadcast of all misleading ads and should extend to all forms of DTC advertising, not just television.

Another goal of the user fee program is to encourage drug makers to assess important efficacy and safety issues earlier in drug development in order to avoid delays in bringing new therapies to market. The PDUFA IV plan provides an added $4 million a year to establish a completely automated application submission and review system with two-way communication capability and improved tracking. In the last five years, user fee revenues have helped FDA develop standards for electronic submission of market applications and consolidate the agency's IT infrastructure. Now FDA will develop a new five-year IT plan that describes the next steps for achieving an all-electronic new drug submission and review environment.