How Can the FDA Ever Improve Drug Safety?

Recently, the U.S. Government Accountability Office determined the FDA lacked "a clear and effective process" to monitor postmarket drug safety. An array of health professionals discussed how the FDA and their real partners -- the mega-pharmaceuticals -- could accomplish that at Institute of Medicine (IOM) workshop this week in Washington, D.C.

One obvious solution to health experts: Drug companies seeking out -- and not avoiding -- new ways to track and collect drug safety data. Tough talk to be sure, but the panel as a whole, unfortunately, reached no consensus on a specific formula for doing so.

Toning down consumer drug ads so people can make more rational choices was another topic of discussion, because many assume unrealistic expectations about a drug they see advertised on TV, according to one University of Michigan expert.

Of course, drug company representatives threw fear into the meeting by reminding the assembled, all these pesky federal regs focusing on risk have a way of making their competitors a bit more wary about introducing new "breakthrough" concoctions, instead of newer versions of older drugs. And, more "incentives" like greater liability protection and longer market exclusivity -- free passes to harm your health -- could boost innovation.

Unfortunately, this week's meeting wasn't related to a July gathering to discuss the FDA's drug safety review process. Considering health debacle related to the antibiotic Ketek, I remain skeptical any real progress will be made. The best ways to protect you and yours from harmful drugs is to become more knowledgeable about any drug you may take and follow the Total Health Program to avoid them altogether.

Reuters.com May 31, 2006

Yahoo News May 30, 2006

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