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FDA mulls enhanced drug disclosure

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The US Food and Drug Administration (FDA) could soon release detailed information on medication rejections, after an advisory panel recommended that the agency open up secretive procedures to the public.

Suggestions made by the Transparency Task Force, created in June after President Obama called for greater freedom of information, include the release of so-called complete response letters, which give detailed information on drug trials and on the reasons for approval or refusal.

These documents are currently secret, with pharmaceutical companies releasing only summaries to investors.

The move comes after doctors and consumer groups criticised the FDA under former President George W Bush for failing to disclose heart risks with GlaxoSmithKline’s Avandia and Merck & Co’s Vioxx.

The regulator complained in December that 70% of new drug applications had missing data. Officials hope that exposing inefficiencies will encourage manufacturers to be more thorough.

Other proposals include releasing the name, address and result of inspections of clinical trials and facilities that make or process regulated products and publishing enhanced side effect reports on the FDA website.

Copyright Press Association 2010
Food and Drug Administration



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