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Published on 25 June 2009

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Rejected drug disclosure urge


The public should be privy to details of drugs rejected by the US drug’s watchdog, according to consumer safety group.

The Food and Drug Administration usually only publishes information on medicines and treatments which it approves for use, but the Pew Prescription Project said health professionals and the consumers could benefit from similar disclosure on those it turns down.

It explained that details about why certain products already on the market were rejected for treatments of different ailments could help protect patients from possible side effects if doctors are already prescribing it for so-called “off-label” use.

Allan Coukell, director of the non-partisan consumer safety group, told the panel of eight top FDA officials: “Lives might have been saved.”

But at a public meeting to discuss ways the agency can make its regulatory decisions clearer, industry representatives also cautioned that findings or data containing confidential company information could harm competition if made widely available.

Copyright Press Association 2009

Food and Drug Administration

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