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The FDA

Following serious FDA failures, Congress may reward the agency with even more money, regulatory power

Monday, November 20, 2006 by: Jerome Douglas
Tags: the FDA, government corruption, government agencies


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(NewsTarget) Various consumer and patient groups joined with a leading cardiologist to urge quick action from Congress to allow the FDA to gain more power than it has now in order for it to require new warnings on medicines and drug post-approval studies. In addition, witnesses from these groups lobbied for a boost to the FDA's budget.

Sheila Burke, co-chair of an Institute of Medicine panel, said "The absence of that [budget increase] would leave the agency starved for resources ... with unclear authority in terms of being able to deal with the industry." Burke indicated that major reforms to improve the FDA's oversight of medicines after they reach the market was needed in light of recent drug safety concerns similar to Merck's pulling of arthritis pill Vioxx from the market in September 2004.

After Vioxx and other safety controversies, "the American people no longer trust the FDA to protect their health," said Cleveland Clinic cardiologist Steve Nissen. Nissen added that Congress needed to act in order for the FDA to rebuild public trust. FDA spokeswoman Kristen Neese said, "The FDA has done considerable work over the past two years to improve our approach to drug safety, and we are committed to taking additional steps."

"Giving the FDA more money without serious reforms and new accountability is like giving crack to a drug addict," said Mike Adams, a consumer health advocate and frequent critic of the FDA. "This agency's utter disregard for public safety poses a threat to the lives of Americans that far exceeds the threat of any terrorist group.

"FDA-approved prescription drugs have killed over half a million Americans since 9/11, and now this Congress wants to give it even more money and power. It indicates just how utterly corrupt our government has become when it comes to making decisions that impact the profits of Big Pharma.

"The problem at the FDA is not a lack of funding," Adams said, "It's a lack of honesty and ethics."

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