New FDA Craziness

Uncanny timing that the same day I posted news about America's dismal healthcare scorecard, the Institute of Medicine (IOM) issued an equally scathing report of their own, calling for dramatic changes in the way drugs are regulated at the FDA.

Among the recommendations that would require Congressional approval to enact:

  • FDA commissioners would serve a single six-year term.
  • Newly approved drugs would include black triangles on their labels, warning consumers their safety was still in question.
  • New drugs would only be approved for five years so the agency could review their safety.
  • A ban on advertising while drugs remain on this probationary period.

With the current Congressional session nearly over, however, there's no hope any reforms will be considered before next year, when federal legislators will reconsider the existing agreement with the mega-drug companies to pay millions to speed up reviews of new drugs. Under current law, those fees cannot be diverted to shore up the agency's woefully underfunded safety division.

Of course, the drug cartel's minister of propaganda, Pharmaceutical Research and Manufacturers of America, would have you believe any notion the FDA is seriously compromised is a big mistake. However, the real mistake would be trusting the FDA's opinions about drug safety, especially considering it can't even assess its own success or failure, says Sen. Charles Grassley (R-Iowa).

New York Times September 22, 2006 Registration Required

ABC News September 22, 2006

Washington Post September 23, 2006

Institute of Medicine September 22, 2006

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