Generic Drug Agency Urges FDA to Rethink its Stance on NDMA

The generic drug industry is urging the Food and Drug Administration (FDA) to “revisit and potentially reassess” its safety limits for common nitrosamines in pharmaceutical drugs and is proposing the agency instead adopt a “balanced risk-based approach” to evaluating drugs for the potential of nitrosamines using science-based considerations based on duration and type of use.

“The generics industry stands ready to work with the FDA so that we can strike the right balance, that of quality and safety,” the Association for Accessible Medicines said in a statement. “Further we stand ready to work with the FDA to mitigate creating or potentially exasperating unintended consequences, such as drug shortages, process improvements that are overburdensome and unsustainable for the FDA and industry, and we refine risk-based approaches to better manage the concerns nitrosamines present.”

On Sept. 1, the FDA announced that it had released new guidance to help drug companies detect and prevent nitrosamine impurities from getting into drugs. The announcement came after waves of drug recalls due to contamination with the nitrosamine NDMA, short for N-nitrosodimethylamine, a probable human carcinogen.

The environmental contaminant turned up two years ago in the blood pressure medicine valsartan and other so-called ARB drugs. Last year, NDMA was found in the heartburn drug Zantac and other medicines containing ranitidine. The FDA ultimately pulled all Zantac products from the market due to safety concerns. More recently, NDMA has turned up in several extended-release versions of the first-line diabetes drug metformin, as well as some tuberculosis treatments.

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