Ex-FDA Employees Slam Drug Approval

The Washington Times (Washington, DC), February 14, 2007 | Go to article overview

Ex-FDA Employees Slam Drug Approval


Byline: Gregory Lopes, THE WASHINGTON TIMES

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. …

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