Generic Drugmakers Take Stand Against New FDA Mandate

Currently, more than 80% of US prescriptions are filled by generic versions of a drug, and the latest proposed requirement for drug companies has generic drugmakers in a bind.

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A federal plan is mandating that generic drug companies update medication labels to warn consumers whenever a health risk is discovered. This initiative puts legal liability on the drugmakers. However, generic drugmakers are rallying for the FDA to decide on each new warning and direct the company to make a labeling change when they see fit. Consumer advocacy groups feel that this burdens the already weighed down FDA to keep track of all drugs on the market.

Under current law, generic drugmakers are not allowed to update health warnings unless mandated directly by the FDA, which is part of a 1984 law on governing generics. The new approach would require generic drugmakers to make updates like brand name manufacturers do after a new risk is discovered. Under current law, once a brand name medication updates its label accordingly, the FDA approves this new language, which then trickles down to the generic versions as well.

This new proposal that gives generic drugmakers control over labels came after a 2011 Supreme Court ruling that found generic drug companies did not control what their labels said and thus could not be sued for failing to alert patients to the risk of their drug. Following the ruling, Public Citizen, an advocacy group, petitioned the FDA to allow generic drug companies to have more control, which could lead to added patient safety.

The FDA is currently accepting public comments on this proposed rule until April 27.

Generic drugmakers argue that the move could increase costs for the generic industry, which would then affect costs to patients. In addition, they say that generic drugmakers do not have the long-term clinical data that brand name manufacturers do, therefore, identifying drug risks could be tricky.

“To delegate decision-making to a manufacturer who does not have all the relevant scientific information would not be responsible and could have harmful consequences,” said Ralph G. Neas, president, Generic Pharmaceutical Association, in a New York Times article.—Kerri Fitzgerald

Source: New York Times. 2015.