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FDA Moves to Improve Generic Drug Label Warnings

By S.Z. Berg

NEW YORK (MainStreet)--The Food and Drug Administration (FDA) announced a proposal to revise drug labeling regulations for generic drugs to create parity among brand name and generic drug manufacturers. The revised rule would allow generic drug manufacturers to revise their drug labeling in order to provide information on newly discovered risks, according to the Office of Management and Budget website, which describes the new rule.

"Almost two years ago, in August 2011, Public Citizen submitted a citizen petition to the FDA asking it to revise its labeling rules to fill the safety gap," Sidney Wolfe, founder and senior adviser, Public Citizen's Health Research Group, said in a statement. "The FDA's proposal suggests that the agency plans to grant that petition."

Current FDA regulations do not allow generic drug manufacturers to update product labeling to include warnings and precautions when manufacturers become aware of a potential risk without undergoing FDA approval. Brand-name drug manufacturers are allowed to do so without FDA approval. Generic drug labeling must match that of the brand-name manufacturer's label. However, some brand-name drugs are no longer marketed whereas the generics remain on the market.

Many potential risks aren't discovered until years after the drug has been on the market. A recent report by the nonprofit consumer rights advocacy group Public Citizen lists 434 generic drugs without brand-name counterparts on the market. The report also shows that there are at least 53 drugs that were approved by the FDA more than a decade ago that have required new warnings in the past 5 years to alert patients to serious or life-threatening risks.

Eleven of those drugs are currently only available as generic drugs.

Generic drugs made up 80% of all prescriptions filled in 2011, according to the Generic Pharmaceutical Association.

The new proposal will address having a requirement that after the FDA approves a labeling revision of a drug manufacturer that all manufacturers of that drug must have conforming labels.

--Written by S.Z. Berg, author of College on the Cheap, for MainStreet