FDA Will Accept More Comments on Generic Labelling Rule

Interested parties will soon get another crack at submitting comments on the FDA’s highly controversial proposed rule that would give generics makers authority to update their labels independently – authority only brandmakers currently have.

The agency signaled in its Fiscal Year 2016 budget request this week that it plans to hold another public meeting in response to a request from a Congressional committee that requested another listening meeting be scheduled with industry. The agency also said it would reopen the comment docket on the proposed rule in order for more voices to be heard.

No timeline was given for when the docket may reopen. The FDA said only that the public meeting would be held as soon as it can be conveniently scheduled.

The FDA received a deluge of comments the last time the docket was open, which, along with an acrimonious reaction from lawmakers, spurred the agency to delay finalizing the rule until the fall of 2015.

Generics makers have lashed out at the rule’s proposal to give ANDA holders the power to update their product labels prior to FDA approval under certain circumstances. GPhA and others say such parity would vastly increase their lawsuit liability and drive up costs for the industry and prices for consumers.

The rule has been aimed in large part precisely at increasing generic liability in some drug injury lawsuits.

Currently, consumers have little legal recourse when injured by a generic drug after the Supreme Court’s 2011 decision in PLIVA v. Mensing found generics makers largely immune from so-called failure-to-warn lawsuits because they are barred from changing a product label independently. — Bryan Koenig