12:00 AM
Feb 05, 2007
 |  BioCentury  |  Politics, Policy & Law

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 and require it to use PDUFA money to impose new pre- and postmarket requirements on drug developers.

The Enhancing Drug Safety and Innovation Act, S. 484, introduced by Senate Health, Education, Labor and Pensions chairman Edward Kennedy (D-Mass.) and ranking HELP member Michael Enzi (R-Wyo.), closely tracks IOM recommendations, including a number that FDA did not address in its plan.

'New science'

In its response, FDA plucked the science-related recommendations from IOM's report and expanded on them. The plan describes steps the agency already has taken, as well as some it incorporated into the PDUFA IV agreement negotiated with industry. In addition, it disclosed new measures, and presented all of these initiatives as manifestations of an "emerging science of safety."

"This new science combines a new understanding of disease and its origins at the molecular level (including adverse events resulting from treatment) with new methods...

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