Does the FDA Stand for Anything?

Although the Food and Drug Administration professes to be “responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation,” the reality after 7+ years of Bush administration and industry canoodling is that the FDA is more concerned with private profit than public health. For the pharmaceutical industry in particular, FDA has come to stand for Free to Do Anything. Here’s further evidence of this disturbing trend, as reported by the New York Times:

F.D.A. Seeks to Broaden Range of Use for Drugs

When federal drug regulators approve a medicine for sale, they limit how drug makers sell it. A drug approved to treat only breast cancer cannot be marketed for lung cancer even if some studies suggest that the medicine may save lung patients.

But the Food and Drug Administration proposed guidelines Friday that would change this, and advocates on both sides of the issue say that lives are at stake.

The rules would allow drug and device makers to provide doctors with copies of medical journal articles that discuss product uses that have not been vetted or approved by the F.D.A. The rules also say that drug companies do not have to promise to adequately test the unapproved use discussed in the article.

Advocates of the rule say the F.D.A. is so slow in assessing drug and device benefits that companies need to be able to hand out medical journal articles so that doctors can learn immediately about life-saving uses.

“The consequence of rapid disclosure of these benefits could be measured in lives,� said Dr. Scott Gottlieb, a former F.D.A. deputy commissioner.

Ken Johnson, senior vice president for the Pharmaceutical Research and Manufacturers of America, said that “journal articles can offer physicians valuable insight that helps them make informed decisions regarding appropriate medical treatments for their patients.�

But critics of the proposal say that drug and device companies have a long history of promoting unapproved drug and device uses that later proved dangerous and that allowing companies to talk about such unapproved uses removes incentives for companies to research adequately whether the new use is actually beneficial.

“People will die if they are getting drugs that don’t have clear evidence that the benefits outweigh the risks,� said Dr. Sidney Wolfe, director of Public Citizen’s health research group.

Representative Henry Waxman, Democrat of California, said the proposed rule “caters to the industry’s desire to market their products without adequate testing or review.� [full text]

One thought on “Does the FDA Stand for Anything?

  1. in about 17 years of nursing I’ve seen several drugs heavily promoted and then yanked from the market after injuries and deaths. these are drugs that went through the testing process. doctors are already getting the off-label sell from drug reps. you might think that doctors would be sceptical of information they get from a sales rep, but the reps can be so convincing, and they bring lunch and all those nice pens.

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