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Tension Building Up in FDA Over Drug Approvals

ugh even during Avandias original trials, overseen by GlaxoSmithKline, the drugs maker, patients taking the drug had more than twice the rate of ischemic heart disease as recipients of placebos.

The medical reviewer for the F.D.A. expressed concerns, but in a further analysis decided that it was less of a problem.

Congressional investigators said the safety group recommended months ago that the drug agency put its severest warning on Avandia. The review group, which holds sway, has not done so.

Senator Charles E. Grassley, Republican of Iowa, and others on Capitol Hill, say the rift between the approval office and the safety office means that the two must separate and that the safety group must have more power. Mr. Grassley proposed such a split in an amendment this month; it failed by one vote.

Top House staff members said the Avandia case had breathed new life into Mr. Grassleys proposal, because the House will soon debate changing the drug agency.

When Dr. Andrew C. von Eschenbach took over the FDA in 2005, he promised improvements, and agency officials said they would no longer be caught flatfooted on drug safety.

Now on the defensive, Dr. von Eschenbach said the agency had done its best in regard to Avandia. It intended to warn patients rapidly when it received information that a drug might be unsafe.

At the same time, he said, the agency had to find a way to ensure that patients did not overreact to uncertain safety problems.


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