Reforming the Drug Safety Paradigm in America

This week's Journal of the American Medical Association features an interesting essay that proposes solutions for reforming the currently "diseased" state of drug safety in the United States.

Based on current monitoring limits (little to none), drug marketing practices (aggressive advertising) and delays in drug approvals (for good reason), the author proposes an alternative three-pronged approach:

  • Each approved drug would go through a conditional approval period in which all marketing would be restricted and labeling would reflect that few studies had been conducted.
  • The FDA needs more authority to regulate drugs after they're approved for consumers so they can impose post-market studies on, rather than negotiate with, drugmakers.
  • An independent, watchdog organization overseeing nonregulatory tasks should be formed.

All of these suggestions are steps in the right direction, as the currently drug safety paradigm is seriously broken. If Congress ever gets around to fixing it, I hope they'll listen to the sage advice of medical professionals like Dr. David Graham.

Journal of the American Medical Association, Vol. 295. No. 17, May 3, 2006: 2072-2075

EurekAlert May 2, 2006

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