| The House Appropriations Committee has approved a provision that would allow The U.S. Food and Drug Administration to require drug makers to conduct postmarket studies as part of the fiscal year 2007 agriculture appropriations bill. FDA requested postmarket trials for 73% of the drugs it approved between 1988 and 2003, but pharmaceutical companies have failed to complete two-thirds of the studies they pledged to conduct, according to reports. Currently, FDA does not have the authority to compel pharmaceutical companies to finish the studies. Under the amendment, FDA would be allowed to launch proceedings to halt the sale of certain drugs if postmarket studies for the medications have not been completed. The impetus to offer the amendment was a recent
Government Accountability Office report that highlighted problems in how FDA monitors the safety of medications after they are on the market. GAO said Congress should consider giving FDA the power to require that pharmaceutical companies follow through on postmarket study promises. As members are aware, the AMC/NOMA has communicated in recent months with the FDA on the related issues of postmarket dissemination of information to physicians, as well as a radio interview of Dr. George Kikano on the effect of Direct-to-Consumer advertising of prescription drugs on the physician-patient relationship.
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