Thursday, May 10, 2007

Senate Approves Bill On Drug Monitoring

I'm surprised this wasn't the FDA charter all along...

"The bill calls for a fundamental change in the philosophy and operations of the drug agency, requiring it to focus on the entire life cycle of a drug — not just the years before its approval — as well as the experience of patients who later take it."-

The Food and Drug Administration would have to establish new systems to monitor the safety of medicines after they hit the market and for the first time could fine drugmakers for false or misleading advertising under a bill approved yesterday by the Senate.

The provisions are part of a major bill to reauthorize the current system that charges drugmakers hundreds of millions of dollars in fees each year to pay for speeded-up reviews of prospective new drugs. The government's authority to levy those fees will expire Sept. 30 unless Congress acts before then. The House has not yet taken up similar legislation.

Senators approved the measure 93 to 1, with Bernard Sanders (I-Vt.) casting the dissenting vote

link to full article

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