The FDA Continues to Fail to do its Job

posted on:
August 16, 2007

author:
Staff

 There can be little doubt that over the years the federal Food and Drug Administration has been controlled to a great extent by the politically powerful pharmaceutical industry. 

That control has made it most difficult for the government agency to be an effective regulator. On too many occasions, when new drugs were being introduced, the FDA sat on its hands and as a result lives were endangered.

A prime example is the regulatory agency's handling of the Vioxx problems. Many observers believe that Avandia – GlaxoSmithKline's diabetes drug – may wind up just like Vioxx. It has been reported that Avandia could cause a 43% increase in heart attack risk. That is most alarming.

The FDA has become too cozy with the companies it regulates, and that comes from the agency's dependence on industry money to fund its operations. That has come about because of the failure of Congress to adequately fund the FDA.

The Prescription Drug User Fee Act (PDUFA), passed by Congress 15 years ago, allowed the drug companies to help fund the approval process. I would like for somebody to explain how that sort of thing is good for people who take prescription drugs. How in the world could anybody expect that system to work? In my opinion, Congress should change that law as soon as possible and fund the agency properly from government sources.

The fast-track avenue was also made available for the first time with the enactment of PDUFA, which allows new drugs to be put on the market much more quickly. History has shown that drug approvals completed too quickly are often associated with later safety problems.

Interestingly, in 1999 the eight priority new drugs the FDA approved in only six months or less included Vioxx and Avandia.

Public Citizen raised warnings about seven drugs that were later approved by the FDA. Those drugs were: Vioxx (pain), Baycol (cholesterol), Propulsid (heartburn), Rezulin (diabetes), Razar (infection), Duract (pain), and Redux (weight loss). In each instance, Public Citizen issued "Do Not Use" warnings on these drugs months and even years before they were removed from the U.S. market for safety reasons. Dr. Sidney Wolfe, Director of Health Research for Public Citizen, made this observation relating to the FDA's effectiveness:

When you're getting paid directly from an industry you're supposed to be regulating, it takes quite a bit of edge out of the regulating.

In 2008 the drug companies will pay the FDA's Center for Drug Evaluation and Research over $400 million in user fees. There are currently 181 drugs that Public Citizen says people should not be taking. Based on the track records of the FDA and the consumer advocacy group, I believe that the best course of action is not to take any of these drugs without first having a detailed conference with your personal doctor and pharmacist.

It should be noted that the FDA spends far more of its limited resources on approving new drugs than it does on monitoring safety after the drugs are on the market.

Two reports from the Government Accountability Office and the Institute of Medicine in 2006 are not good news on that subject. Congress has yet to give the FDA the authority to require the drug companies to carry out post-marketing studies. When it comes to a dispute between the approval group and the safety folks at the FDA, guess who wins the debate? Congress must take action to make the FDA a good, effective regulatory agency. There is no time for further delay.

 

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