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Tension Building Up in FDA Over Drug Approvals

The US Food and Drug Administration, caught on the wrong foot again in just two years over the safety of the drugs it approves, is facing congressional investigations.

First it was Vioxx, the painkiller, then some antidepressants and most recently Avandia, the diabetes pill.

Concerns over that drug and others have led Republicans and Democrats in the House and the Senate to call for investigations.

The hearing next week may highlight the growing internal dissension between officials who approve drugs and those who track the safety of drugs after they have been approval. Tension between the groups has long been common, but in recent months it has erupted into sniping.

It all came into the open at an advisory committee hearing last month on whether to approve a new arthritis drug.

On one side was Dr. David Graham, author of an internal report that found that Avandia substantially increased the risks of heart attack, findings similar to the medical journals report.

On the other, Dr. Robert J. Meyer, an office director in the drug review division, and his boss, Dr. John Jenkins, were in a group deciding against warning about the potential risks.

There was little chance that the advisory committee or the drug agency would approve the arthritis drug, Arcoxia, at the hearing.

Behind the scenes, agency officials were battling over Avandia. Dr. Graham told the committee that top agency officials had demanded an unreasonable level of certainty about a drugs risks before agreeing to warn the public.

They assume its safe, Dr. Graham said of the top officials analyses of safety data. Which is just looking at things all the way wrong.

Dr. Jenkins said Dr. Grahams characterization of how we look at safety data is simply false.

We make our best informed judgment about what the regulatory action should be, Dr. Jenkins added.

The fact remains tho
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