NCPA - National Center for Policy Analysis


October 11, 2006

Five experts who have advised the Food and Drug Administration (FDA) on drug safety threw their weight behind mounting criticism that the agency does not adequately protect the public from unsafe drugs.  They say that FDA-mandated studies on prescription drugs can miss serious safety issues before and after a drug's approval, according to five current and former members of the agency's Drug Safety and Risk Management Advisory Committee.

The group, which published a critique of the agency in the Archives of Internal Medicine, includes current panel members Curt Furberg, Robyn Shapiro and Arthur Levin, and former panel members Peter Gross and Brian Strom.

They recommend that Congress take the following steps to improve the agency's monitoring of drug safety:

  • Provide FDA with more direct legal authority to pursue safety violations.
  • Create a "conditional" drug approval policy for certain types of drugs.
  • Provide FDA with additional funding to improve safety-monitoring operations and require that it do so.
  • Mandate a broader representation of safety experts with fewer potential conflicts of interest on advisory panels.
  • Ban consumer advertising of newly approved classes of drugs until they have been on the market long enough to detect safety issues.

The group also recommends the creation of a new agency -- the Center for Drug Safety -- outside of FDA's Center for Drug Evaluation and Research.  They say that the FDA does not currently have authority to unilaterally pull dangerous drugs from the market, force changes to drug label warnings or penalize companies that do not adequately monitor safety.  The group also contends that FDA "lacks the money and structure to insulate itself from the influence of the pharmaceutical industry."

Source: Christopher Lee, "Report Faults FDA on Drug Safety," Washington Post, October 10, 2006.

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