FDA Sued for Failure to Alert Diabetics to Effective Drug Alternatives

FDA Sued for Failure to Alert Diabetics to Effective Drug Alternatives


07/22/2010 // West Palm Beach, FL, USA // Sandra Quinlan // Sandra Quinlan

Washington, DC—A nonprofit doctors group filed a lawsuit against the U.S. Food and Drug Administration (FDA) this month, after they failed to notify patients of dietary alternatives to dangerous diabetes drugs such as Avandia, a highly scrutinized diabetes medication. The group, Physicians Committee for Responsible Medicine (PCRM), alleged they petitioned the FDA to require that such alternatives be included on labels for the drugs, but to no avail, according to a Monday, July 19, 2010 PCRM news release.

Plaintiffs in the case, who are all doctors, alleged that while the PCRM sent the FDA an administrative petition regarding the lack of labels alerting patients of substitutes to dangerous diabetes medications, administration commissioner Margaret Hamburg, M.D., did not appear to act on the matter.

The National Institutes for Health funded a study in 2006, in which it was discovered that low fat plant-based diets were just as successful as oral drugs in the reduction of blood glucose and cholesterol in individuals with type 2 diabetes. However, plant-based diets do not increase the risk of stroke, heart failure, or death.

“A plant-based diet is as effective as drugs for lowering blood sugar and much more effective for trimming body weight… Doctors and patients need the facts,” PCRM president Neal Barnard, M.D., said.

Additionally, researchers apparently associated Avandia with potentially lethal side effects, noting that the drug might have contributed to the injuries and deaths of thousands of diabetics.

The lawsuit contends, “PCRM’s petition requested that FDA require a disclosure in the labeling of drugs, such as Avandia, used to manage blood glucose in diabetes treatment. The disclosure would state that a low-fat plant-based diet has an efficacy and safety profile that can be as favorable as, or more favorable than, oral diabetes medications. FDA has failed to provide a substantive response to PCRM’s petition in a reasonable time, in violation of the Administrative Procedure Act.”

The lawsuit was filed in the U.S. District Court for the District of Columbia. The case is underway.

Legal News Reporter: Sandra Quinlan- Legal News for Product Liability Attorneys.

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