PhRMA, GPhA Push Alternate Generic Labeling Rule
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.
The FDA would only take responsibility for labeling after a brand drug’s first generic hits the market.
The plan comes as the FDA prepares to meet March 27 with industry to consider the proposed rule to give generics firms labeling parity with brandmakers. The proposal would give generics firms the authority currently reserved for brandmakers to change labels prior to agency approval under certain circumstances. It drew intense criticism from both camps the last time the FDA considered it, spurring the agency to delay any final decision until fall 2015 and convene a second meeting on the subject this month.
Generics makers in particular have blasted the proposed rule, saying it would vastly increase their liability in lawsuits alleging failure to warn of potential drug dangers.
View the proposal at www.fdanews.com/03-3-15-GenericLabellingProposal.pdf. — Bryan Koenig