An act to revitalize the US Food and Drug Administration (FDA) was passed in the Senate yesterday by an overwhelming 93 to 1 majority. The House appears set to review an equivalent bill in the next few weeks which may see the FDA with much bigger teeth in the second half of this year.

Essentially the new legislation would give the FDA more power and more money to increase its role in monitoring and to a certain extent enforcing drug safety over the whole life cycle of a drug from development, through to clinical use.


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The draft Bill followed all the key recommendations of the Institute of Medicine's report on the future of drug safety.

The main thrust is to give the FDA a more proactive role in overseeing drug safety and more power to intervene and enforce changes.

There are four main areas: "active surveillance" of drug safety, issuing changes to drug labels and patient information, regulating drug advertising, and making sure high risk drugs are not easy to get hold of.



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The FDA would also have powers to require doctors to have additional training if they are going to prescribe drugs with higher than ordinary risks.

In the area of drug label changes, the FDA would have more power to enforce the drug companies to make changes instead of as now where they only have power to request changes.

And where consumer advertising of drugs is concerned, the bill was amended to remove the proposed freeze on advertizing new drugs, and instead the FDA would have power to fine drug companies who made false or misleading claims.

Media reports say that the Bush administration is not in favour of the bill but is not actively opposing it; their position is that the FDA already has enough power.

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The Bill is number S1082.

Click here for THOMAS, the legislative information site of the US Library of Congress.









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