FDA Gets A Load of Scorching Criticism From Lawmakers & Whistleblowers

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U.S. lawmakers criticized the Food and Drug Administration's monitoring of the risks of the antibiotic Ketek (Sanofi-Aventis) and some other prescription drugs on Tuesday. At a hearing on the FDA's drug safety oversight, lawmakers said the agency stifled dissent about the risks of drugs when top managers disagreed. They cited problems with Ketek, Vioxx (Merck & Co. Inc.'s withdrawn arthritis drug) and antidepressants made by several companies.

"With each of these drugs, it appears that the FDA is not seriously questioning whether the risks outweigh the benefits of the new drug," said Rep. Bart Stupak, a Michigan Democrat who chairs a subcommittee of the House of Representatives Energy and Commerce.

"One must ask, if the FDA is not protecting its client, the American people, whose interest is being protected?" Stupak said.

Iowa Republican Sen. Charles Grassley, a vocal FDA critic, told the committee that "scientific dissent is discouraged, quashed and sometimes muzzled" inside the agency and "there's widespread fear of retaliation for speaking up about problems."

http://www.sciencedaily.com/upi/index.php?feed=Science&article=UPI-1-20070213-19583200-bc-us-fda-analysis.xml

The Food and Drug Administration's pullback on the use of a controversial antibiotic yesterday did little to quell its critics, who today went before Congress to condemn the agency's safety practices. On Monday, FDA officials announced they would restrict approved uses of Sanofi-Aventis's antibiotic Ketek. The announcement came a day before a House subcommittee was to hold hearings on alleged pressure tactics by FDA leaders on subordinates to approve Ketek and other drugs.

John Jenkins, director of FDA's office of new drugs, said the decision was made after a reevaluation of Ketek's risks and benefits.

But if the announcement was timed to mute FDA's critics, it was not successful. A string of critics, including researchers, current and former FDA scientists, expert FDA advisors and members of Congress appeared to hammer the agency's record.

Little of the criticism was new; detractors have blasted the agency since 2004, when Merck's arthritis drug Vioxx was pulled from U.S. pharmacies because of evidence it raised the risk of heart attacks.

http://www.cleveland.com/news/plaindealer/index.ssf?/base/news/117144645682230.xml&coll=2

A prominent Cleveland Clinic cardiologist on Tuesday accused the Food and Drug Administration of making inappropriate concessions to the pharmaceutical industry that put dangerous drugs on the market and let sales continue after safety questions were raised.

"The American people no longer trust the FDA to protect their health," said Steven E. Nissen, head of the Clinic's Department of Cardiovascular Medicine. He urged Congress to pass legislation to boost the safety of drugs and medical devices.

Nissen and a half-dozen other witnesses before the House Commerce subcommittee on oversight and investigations described repeated cases where the FDA ignored evidence that drugs were unsafe.

"FDA managers were afraid to be perceived as holding up an important drug, and so they felt pressured to ap prove it," said David Ross, a former FDA em ployee who told how the agency didn't act on evi dence that the antibiotic Ketek, made by Sanofi Aventis, causes liver failure.

http://washingtontimes.com/business/20070213-100908-6407r.htm

David Ross, a physician who worked for the FDA for 10 years, yesterday said the agency has developed a "culture of approval" for drugs.

"Overall, there is a culture of approval to get a drug product on the market as soon as possible. If there is a way to get it out, then you find some way of doing it," he said.

At a House Energy and Commerce oversight and investigations subcommittee hearing yesterday, Dr. Ross said that before Ketek's approval, the FDA was aware Sanofi submitted fabricated data and knew the drug could cause liver failure.

"An unsafe drug got past the system despite warning after warning about fraud, liver damage and death because FDA managers at the highest levels refused to listen," he said. "Without significant changes in our drug safety system and FDA, we are certain to see more Keteks."