Ooops.
F.D.A. Official Admits 'Lapses' on Vioxx:
After the Food and Drug Administration insisted for months that it did nothing wrong in its oversight of the withdrawn pain pill Vioxx, a top agency official acknowledged “lapses” in the agency's actions before a Senate panel on Tuesday.
Dr. Sandra Kweder, deputy director of the office of new drugs at the agency, also said the power to require label changes “would be very helpful.”
Most witnesses testifying before the panel, the Senate Committee on Health, Education, Labor and Pensions, agreed, saying the agency should have the authority to force label changes and make companies conduct tests if safety issues arose after a drug was approved.Dr. Kweder blamed difficult negotiations with Vioxx's maker, Merck, for the delay. “We don't have the authority to tell a company, 'This is how your label has to look,' ” she said. “We have to negotiate with the company the specific language of how things should be worded, the placement, those kinds of things, after talking to them.”
The other lapse, Dr. Kweder said, was “the failure of that information somehow to be in the forefront of the consciousness of the prescribing physician.”
Millions of people took Vioxx in the years after its risks to the heart became apparent. As a result, as many as 55,000 patients may have died from heart attacks and strokes induced by the drug, according to estimates by drug safety officials at the F.D.A. Merck withdrew the drug from the market in September, after a test showed that it doubled the risk of heart attack and stroke.
Dr. Kweder's admission could cause difficulties for Merck, which is battling more than 800 lawsuits filed by thousands of patients claiming that they were injured by Vioxx.
Of course, the FDA is under no pressure to protect consumers, no pressure at all. Corporate Profits Uber Alles.
