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Will a New Congress Clean Up the FDA?

With a new Congress -- now in the hands of the Democratic Party -- convening in four weeks, what can really legislators really do to protect Americans from the corrupt excuse that passes for drug safety enforcement known as the FDA?

The most intriguing of the bunch -- Senate Bill 930 sponsored by Sens. Charles Grassley (R-Iowa) and Chris Dodd (D-Conn.) -- would separate the agency's drug safety office from its drug approval division, making it an independent entity. Also, the FDA would ideally have more authority to require drugmakers to better monitor the safety of any new drugs.

And, while Grassley has fought the good fight for FDA reform for several years, he'll have more help from agency critics on the Democratic side -- among them Sen. Edward Kennedy (Mass.), Rep. John Dingell (Mich.) and Rep. Henry Waxman (Calif.) -- stepping into key leadership roles.

With an almost evenly divided Congress and President Bush ready to veto any legislation not to the liking of the FDA, all these plans for reform may be moot at best. As long as 80 percent of the agency's resources are focused on approving new drugs, and drug safety is an afterthought, however, changes on Capitol Hill won't make a difference any time soon.

One indication, perhaps, patients are getting the message on their own and turning away from useless and often toxic drugs: Pfizer's recent downsizing of its once untouchable sales force.

Drugs and Medications News December 7, 2006