Friday, September 21, 2007

Congress Passes Bill Expanding FDA Powers

Article on cnn.com -- Drug safety bill heads to Bush's desk.  Here's an excerpt:

The bill would give the FDA the power both to require drug companies to further study the safety of medicines if needed and to mandate new label warnings, when problems do appear. The FDA would be able to fine companies to ensure compliance with those two new authorities.

The legislation also would require companies to publicly release results of all clinical trials that show how well their drugs performed, although the level of disclosure remains to be determined.

The FDA also would gain the ability to fine drug companies for not completing follow-up studies on their drugs after they've won government approval. Those studies now often remain undone, often leaving important safety questions unanswered.

***

The legislation also would force the FDA to further step up its active surveillance for new safety issues with drugs. That system traditionally has been largely passive.

The manufacturers of certain new drugs would have to draft for each product a so-called "Risk Evaluation and Mitigation Strategy" that can include medication guides distributed with each prescription to ensure the medicine's safe use.

BGS

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