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Will Drug Safety Improve After a FDA Revamp?

In response to last fall's scathing report from the Institute of Medicine (IOM), the FDA announced a list of initiatives yesterday supposedly aimed at improving the sorry excuse that passes for drug safety in America.

Because FDA czar Andrew von Eschenbach regards the IOM report merely as a substantial amount of advice, and not the centerpiece for major reform, however, these latest initiatives -- while a good first baby step in the right direction -- don't go nearly far enough to revitalize drug safety.

  • Launching a pilot program to produce safety profiles on new drugs on the market for 18 months.
  • Forming another advisory committee of outside experts who will suggest ways the agency can better report drug risks to the public.
  • Generating online newsletters to update consumers periodically on the safety status of newly released drugs.
  • Creating better communications channels between FDA drug reviewers and those who follow the alleged safety of the drugs reviewers approve later on.

All these superficial measures may sound good, but all of them avoid the obvious problem, IOM says: Not giving the agency's Office of Drug Safety more authority to monitor drugs after they're released to the open market. That fact alone is reason enough not to put your trust in any governmental agency and take ownership for your own health.

Washington Post January 31, 2007

USA Today January 30, 2007