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Published on 27 September 2007

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FDA to get power to fine firms over drug safety

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The FDA is to get new powers to ensure the safety of prescription drugs in the USA.

A new Bill requires companies to publicly release results of all clinical trials that show how well drugs have performed, although the level of disclosure is yet to be agreed.

It will also give the FDA the power to require drug companies to further study the safety of medicines if needed, and to mandate new warnings on labels.

The move is being hailed as the most significant drug safety legislation in the USA for more than 40 years, and was passed 405-7 in a vote in a House of Representatives vote.

The Senate is expected to approve it shortly, and then President George W. Bush will sign it into law.

The FDA will also be allowed to charge drug and medical device manufacturers to cover its costs of reviewing products seeking approval.

The regulator had previously warned that if the fees programme was not renewed, it would be forced to lay off 2,000 staff.

The FDA will also gain the ability to fine drug companies for not completing follow-up studies on their drugs after they have secured government approval.

Companies often agree to undertake these studies, but are slow to get them started and sometimes never complete them.

Copyright © PA Business 2007

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