Both Houses of Congress have now passed legislation that would require the public disclosure of the results of drug studies and would give the FDA more authority to ensure the safety of our prescription drugs. Next step is for Bush to sign this bill.
This bill is a compromise between the House and Senate and is the result of weeks of negotiations. Talks were stalled for a while due to a provision in the Senate version of the legislation that would have made it harder for families to sue a drug company if they had suffered from the side effect of a drug.
Passage came after Sens. Coburn (R-OK) and Burr (R-NC) released holds related to a provision they favored that would have bolstered the legal standing of drug makers in product liability lawsuits. That measure, which Burr placed in the Senate version of the bill, would have given FDA new powers over drug labeling, solidifying the preemption defense that drug companies have used against litigation, but was scuttled in the version passed by the House. The bill now goes to the president, whose sign-off is almost certain.
Sure, the bill could be stronger in some key ways, especially on conflicts of interest on FDA advisory committees, but overall this bill will take some critical steps in giving patients key information on the risks of prescription drugs on the market.