FDA Helpless in Regulating Drug Industry

[Guest guest]

http://www.ombwatch.org/article/blogs/entry/2812/18 FDA Helpless in Regulating Drug Industry The New Standard reports that neither the FDA nor the pharmaceutical industry have proven the safety of hundreds of drugs already approved for the market. How does such a regulatory gaff occur? From the article by Michelle Chen: Under the Federal Food, Drug, and Cosmetic Act, the FDA can approve drugs despite unresolved safety concerns, but it can also require further studies by the manufacturer once a drug is released onto the market. The problem is manufacturers aren't holding up their end of the bargain. According to an FDA notice in the Federal Register, for FY

2006, 71 percent of the required further studies are pending and 3 percent are delayed. Meanwhile, only 15 percent are ongoing and a mere 11 percent have been submitted. "Get off your ass and take your government back." ~Rocky Ward

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[Guest guest]

Hi Rocky,

 

When I was getting my Bachelor's our Statistics

instructor said some very interesting things. In this

case I will repeat, " Follow the money trail and you

will learn the bias of a study " .

 

Leon