FDA plays science card
FDA unveiled its plans to use existing laws and anticipated increases in user fees to implement some of the Institute of Medicine's recommendations for enhancing drug safety last week. While the September 2006 IOM report emphasized institutional and legal issues, the agency positioned its plan as firmly rooted in what it called the science of safety.
But the FDA version is unlikely to meet the desires of some congressional critics. While some members of Congress greeted the response as a good first step, they emphasized that it didn't go far enough to overcome public and political skepticism about the agency's ability to protect the American public from unsafe drugs.
Two days after the agency's media roll out, the chair and ranking member of the Senate committee that has jurisdiction over FDA described how they plan to change the law to give the agency additional authority