The Senate Health, Education, Labor and Pensions Committee on Thursday held a hearing on a drug safety bill (S 3807) co-sponsored by committee Chair Mike Enzi (R-Wyo.) and incoming Chair Edward Kennedy (D-Mass.), AP/Washington Post reports (Bridges, AP/Washington Post, 11/17). According to CQ HealthBeat, elements from the bill might be addressed next year when the Prescription Drug User Fee Act is up for reauthorization (Armstrong, CQ HealthBeat, 11/16). The bill would:
Have FDA conduct an annual review of new medications;

Have pharmaceutical companies file with FDA 15-day, quarterly and annual reports on adverse events related to new medications, as well as a plan "to assess known serious risks and to identify unexpected serious risks."

Possibly require post-market, or Phase IV, clinical trials;

Establish a Drug Safety Oversight Board to mediate disputes between FDA and pharmaceutical companies (Kaiser Daily Health Policy Report, 11/16);

Limit direct-to-consumer advertising on new drugs for two years after approval (Cohen, Newark Star-Ledger, 11/17);

Establish the Reagan-Udall Institute for Applied Biomedical Research -- funded initially by the federal government and later by a combination of federal, industry and philanthropic funds -- to consider proposals to reduce the time required to assess the safety of new medications;

Require pharmaceutical companies to post the results of Phase III and Phase IV clinical trials in a public database (American Health Line, 11/16); and

Call for increasing drug industry user fees to FDA.

Comments
"Two panels of witnesses -- including representatives from industry, consumer and patient groups -- praised the bill's timeliness, saying it would improve safety -- and the public's confidence," the AP/Post reports (AP/Washington Post, 11/16). Kennedy said, "The FDA itself urgently needs treatment," adding, "We have been very lax, generally ... in the FDA in post-market surveillance." Kennedy also said that Congress must "increase the FDA's budget, so that it can do a better job of guaranteeing drug safety" (CQ HealthBeat, 11/16). Sheila Burke, chair of an Institute of Medicine panel that recommended changes at FDA earlier this year, said, "If there ever was a time that it was critical to address these issues, it is now" (AP/Washington Post, 11/16). Consumers Union President and CEO Jim Guest said the bill is a "good first step" (USA Today, 11/17). Guest added that some provisions, including the power to assess civil penalties, should be strengthened (AP/Washington Post, 11/16). Johnson & Johnson Vice President Adrian Thomas said a two-year moratorium on DTC advertising for newly approved drugs "represents a troubling change" (Newark Star-Ledger, 11/17).

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