FDA plan would share drug rejections

Bloomberg News / May 20, 2010

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WASHINGTON — Drug rejections, plant inspections, and detailed side-effect reports would be shared with consumers for the first time under a new plan from US regulators.

The Food and Drug Administration proposed 21 steps yesterday to expand the public’s knowledge of medicines, medical devices, food, and cosmetics, including when they fail to meet federal standards. Public comments on the proposals will be accepted until July 20.

Lawmakers, doctors, and consumer groups criticized the FDA under former President George W. Bush for failing to disclose heart risks with GlaxoSmithKline PLC’s diabetes pill Avandia and Merck & Co.’s painkiller Vioxx. The FDA created a Transparency Task Force in June in response to the Obama administration’s call for government agencies to be more open with information.

The task force, led by FDA Principal Deputy Commissioner Joshua Sharfstein, recommended the agency start disclosing when products are tested in people, submitted for marketing authorization, withdrawn, or denied approval. This would include releasing response letters sent to drug makers explaining why their products are rejected.

The Biotechnology Industry Organization is still reviewing the report and wasn’t available for comment.