Panel of FDA Experts Urges Stricter Testing and Standards for Diabetes Drugs

By Aaron Poehler

Published on July 03, 2008

A Food and Drug Administration panel comprised of outside medical experts has recommended that the agency impose stricter standards for approval of drugs for the treatment of diabetes, including long-term studies on cardiovascular effects.

By a vote of 14-2 on Wednesday, the panel of advisers advised the FDA to require drug makers to demonstrate that experimental diabetes drugs submitted for FDA approval do not increase cardiovascular risks.  While the panel's recommendations are not binding, the FDA generally tends to follows such recommendations as a matter of course.  

Cardiovascular problems are the leading cause of death in diabetics.  Last year, a firestorm of controversy erupted when GlaxoSmithKline's Avandia, then the top-selling diabetes drug, was said to raise the risk of heart attacks in an analysis published in the New England Journal of Medicine.  GlaxoSmithKline has consistently denied the allegations and asserts that Avandia is completely safe; the drug remains on the market despite an FDA safety alert regarding the potential heart safety issue. 

If new, stricter standards are imposed, research and development costs for drug makers could rise in order to comply with new testing requirements.  AstraZeneca and Bristol-Myers Squibb are expected to submit their new diabetes drug saxagliptin (proposed brand name Onglyza) for FDA approval soon; Merck has already received FDA approval for its diabetes drug Januvia, which would not be subject to any new requirements.

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