Petition Calls for Reform of FDA Regulation of Generic Drug Labels

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Advocacy group petitions agency to let generic drug manufacturers update labels.

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Public Citizen, a consumer rights advocacy group, filed a petition last month asking the US Food and Drug Administration (FDA) to amend regulations that prevent generic drug manufacturers from updating product labels with pertinent safety data.

According to the petition, manufacturers of generic drugs are not authorized to update their labels through the prior-approval-supplement (PAS) or changes being-effected (CBE) procedures available to the manufacturers of brand-name drugs. Public Citizen argues that the FDA should amend its regulations to allow generic manufacturers to update labels through PAS and CBE procedures.

The advocacy group argues that revising FDA drug label regulations will allow generics manufacturers to leverage their information about “product safety and effectiveness” and to revise drug labels to reflect risks identified by the manufacturers.

The petition notes that in 2010, generic manufacturers “captured more than eighty percent of the market” within six months of a brand name drug’s patent expiration, rendering the brand name manufacturer both less motivated and less able to monitor for uncommon adverse health effects. Public Citizen further argues that the FDA has neither the resources nor the capability to monitor the over 11,000 drugs on the market without the help of generic drug manufacturers.

At least one critic of the petition, however, argues that allowing generics to update labels will result in a violation of the Federal Food, Drug, and Cosmetic Act, which requires that generic and branded drugs maintain the same labels.