PhRMA, GPhA Push Alternate Generic Labeling Rule

Tuesday, March 10, 2015

Source: FDA News

Brand and generic drugmakers want the FDA to take responsibility for safety labeling changes to all drugs with at least one generic equivalent and scrap its proposed rule to give generics firms the ability to update label safety information independently.

The plan, developed jointly by PhRMA and GPhA, would base labeling changes on data gleaned from the FDA’s Sentinel drug safety surveillance system and make the FDA the central arbiter of any updates to a drug’s safety warnings. It could potentially limit brandmakers of their failure-to-warn liability, since the FDA would be responsible for safety label updates.

Under the plan, the FDA would review company requests to modify safety information. In addition, when the agency sees postmarket data in its Sentinel database that suggests a new or heightened safety risk, it could request the label change.

If the FDA determined a drug needs new safety information, then all manufacturers — brand and generic — would have 30 days to update their drug labels to reflect the FDA-approved changes, preferably via electronic labeling, under the GPhA and PhRMA proposal.

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