- The Washington Times - Tuesday, February 13, 2007

Former Food and Drug Administration employees yesterday told lawmakers the federal drug approval process ignores safety concerns for approved drugs.

Scrutiny over the Food and Drug Administration’s (FDA) drug approval process heightened after the agency’s decision to modify its approval of the antibiotic drug Ketek, sold by Sanofi-Aventis. Ketek as of Monday is FDA-approved for only pneumonia after the drug was found unsafe to treat bacterial infections associated with sinusitis and chronic bronchitis.

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.”

FDA was not invited to testify at the hearing but an agency spokeswoman defended the drug approval process.

“On difficult scientific questions, it is sometimes the case, even after we reach a decision, an individual or individuals who were part of the decision-making process may not agree,” said FDA spokeswoman Kristen Neese. “There is broad support for this scientific process and recognition that in some cases the opinion of the majority of scientific peers may take precedence over any one individual view.”

Bill Vaughn, a policy analyst with Consumers Union, said more problems exist with the FDA’s handling of drugs once they are on the market rather than during the approval process. A drug approval usually takes between three and four years.

“We don’t want the drug approval process to slow down,” Mr. Vaughn said. “Everybody wants life-saving drugs on the market. It is the post-approval process that needs to be much stronger.”

The spotlight began to glare on FDA’s oversight of drug safety in 2004 when Merck Co. pain reliever Vioxx was linked to heart attacks and strokes. In addition, antidepressants such as GlaxoSmithKline’s Paxil have been tied to suicide risk in children.

Congress is simmering over the FDA’s approval of Ketek and apparent refusals to cooperate with lawmakers on the agency’s methods for sending new drugs to market.

Sen. Charles E. Grassley, Iowa Republican, a longtime critic of the FDA, said the agency stonewalled when his staff attempted to obtain information on Ketek, revealing a relationship with the drug industry that has become “too cozy.”

“The integrity of the agency is at stake,”he said.

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