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Jim Lewis
Jim Lewis
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FDA Announces Safer Warning Labels For Generic Drugs

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The United States Food and Drug Administration (FDA) has announced a set of regulations that will improve generic drug warning labels. The agency’s new rules come after a petition that demanded a safer system of warnings for off-brand pharmaceuticals.

The risks of drugs released to the market often take years to become clear; however, the current regulations imposed by the FDA do not allow generic drug manufacturers to update their product labels when a drug’s risk becomes known without first going through an FDA approval scheme. This is contrasted with brand-name drug manufacturers, who can simply revise their labels without the approval of the federal agency.

Current rules stipulate that generic drug labels must match those of their brand-name counterparts, yet the advocacy group Public Citizen has called attention to over 400 generic drug brands that have no brand-name equivalent on the market, meaning they are effectively stuck with the labels they have pending FDA approval, regardless of any newly-discovered dangers associated with the drug.

The General Pharmaceutical Association estimates that 80% of all prescriptions that were filled in 2011 consisted of generic drug brands, so the new FDA regulations are a welcome change given that so many generic labels may not advertise the most recent or up-to-date risks associated with the drug in question. Consumers should have the most information possible on any drugs they are taking, which means manufacturers should have the latitude to revise their labels if need be.