HealthLawProf Blog

Editor: Katharine Van Tassel
Concordia University School of Law

Wednesday, June 15, 2005

Critics of FDA's Drug Safety Oversight Board

The Washington Post reports that the new Drug Safety Oversight Board has been strongly criticized by FDA whistle-blower David Graham and Senator Grassley.   The FDA created the board to restore confidence in the nation's drug supply but according to Graham and Grassley, it will set back efforts to improve drug safety and will not make it any easier to take dangerous drugs off the market.  They conclude that the panel is "severely biased in favor of industry" and that "the FDA cannot be trusted to protect the public or reform itself."  The FDA announced the 15-member board last fall, and formally was established last month. 

Drug safety has become a hot topic lately, with Congress and many federal agencies addressing the issue.  Medicare Administrator Mark McClellan has proposed a plan to use billing and health care information collected from Medicare beneficiaries to create a more effective surveillance system for prescription drugs on the market.   According to the Los Angeles Times, he has suggested collecting adverse event information from Medicare beneficiaries who enroll in the new prescription drug benefit.  Officials would use billing data from the benefit and combine it with health care information already collected by the Medicare program when beneficiaries submit claims.  A computer system would then cross reference the information and detect problems with medications.  Sens. Grassley and Baucus are in the process of drafting legislation that would allow CMS to establish an electronic monitoring system. [tm]

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