Sens. Edward Kennedy (D-Mass.) and Michael Enzi (R-Wyo.) of the Health, Education, Labor and Pensions Committee on Tuesday released a draft bill that would give FDA "better tools to deal with postapproval hazards" for new prescription drugs and encourage further research on such medications, CQ HealthBeat reports. According to a summary of the bill, "[I]t is not possible to know everything about a drug at the time of approval," and "requiring sponsors to obtain all safety information before allowing the drug on the market would unduly delay patient access to new therapies." Enzi and Kennedy recommend that FDA have better options for dealing with postapproval drug safety issues, including the ability to quickly change a drug's label, a process that currently can take months or years. The bill also would require drug companies to agree with FDA on a "Risk Evaluation and Management Strategy," which would include an annual review of the product for three years. The provision also would require drug companies to file 15-day, quarterly and annual reports on adverse drug effects, as well as a surveillance plan "to assess known serious risks and to identify unexpected serious risks." REMS also could include requisite postapproval clinical trials and restrictions on direct-to-consumer advertisements after a drug has been approved. The bill calls for creation of a Drug Safety Oversight Board to mediate disputes between FDA and drug companies over REMS.

Speedier Drug Safety Assessments
The bill also calls for the creation of the Reagan-Udall Institute for Applied Biomedical Research to consider methods for more quickly assessing the safety of drugs to speed their path to the market. The institute would be funded initially by the federal government and later by a combination of federal, industry and philanthropic funds. The bill would also require pharmaceutical manufacturers to post the results of Phase III and Phase IV clinical trials in a public database. Enzi and Kennedy hope to introduce the bill before the August congressional recess, Ryan Taylor, a spokesperson for Enzi, added (Reichard, CQ HealthBeat, 7/19). According to the Boston Globe, the measure "comes in response to weaknesses in the regulatory process highlighted by the market withdrawal of Vioxx" (Henderson, Boston Globe, 7/19).