SAE report triggers calls for FDA reform

In the wake of yesterday's news about adverse events, the FDA is getting a splash of cold water to the face. The Archives of Internal Medicine report showed a doubling of serious side effects, including death, from 1998 to 2005--and now, there's an outcry for reform.

But what to do? Congress is asking for money so the FDA can hire more scientists and drug-safety experts. Politicians also are calling on the agency to act on the adverse event data already collected. Meanwhile, the agency suggests that side effects may not have increased, just reporting of side effects. And the debate rages on.

- read the article from the Chicago Tribune

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