The Food and Drug Administration withheld vital information on an anti-pneumonia drug from one of the agency’s own advisory panels, a U.S. senator charged.
“The Foodand Drug Administration can’t be in the business of misleading the public and hiding the truth,” Sen. Chuck Grassley, R-Iowa, said in a news release.
Grassley said that the FDA withheld negative information about Ketek, an antibiotic designed to treat pneumonia. Grassley raised his concerns in a letter addressed to new FDA Commissioner Andrew von Eschenbach.
The FDA will meet today to reconsider the drug. It was approved for bronchial diseases in 2004, but the Public Citizen Health Research Group put the drug on its “do not use” list because it was considered toxic to the liver.
The FDA later reported that Ketek had been linked to 12 cases of acute liver failure, including four deaths.
Grassley tried and failed last week to block von Eschenbach’s confirmation as FDA chief. Grassley said he was angry that the FDA had obstructed his investigation of the Ketek clinical trials.
In Wednesday’s letter, Grassley asked von Eschenbach to address reports that FDA officials offered “fraudulent” data on Ketek’s safety because reporting on the liver toxicity of the drug wouldn’t be “productive.”
FDA officials didn’t return requests for comment. But published reports Wednesday said that internal agency studies — scheduled to be discussed today and Friday — found Ketek was safe and effective.
