Since the Supreme Court’s recent 5-4 decision in Mutual Pharmaceutical Co. v. Bartlett established that makers of generic drugs cannot be sued under state law for adverse reactions to their products, the question on the lips of safety cognoscenti has been, “wither generic drug safety?”
The Supreme Court’s decision pushed to the head of the line concerns over bioequivalence, Narrow Therapeutic Index and – as biosimilars become a part of the conversation -- therapeutic interchangeability.
Well on Wednesday (yes, the very day before the Fourth of July holiday), the FDA posted a notice on the OMB website that it plans to published a proposed rule to “create parity” between generic and innovator drugs relative to how they update their labels. Buried treasure.
(Under current FDA regulations, generic manufacturers cannot update their products’ labeling, even if they become aware of a potential risk not stated in the labeling. In contrast, brand-name drug manufacturers can update warnings and precautions before getting FDA approval.)
The FDA’s new proposal would also address requirements that all manufacturers of the same drug submit conforming labeling revisions after the FDA has approved a revision by one manufacturer of that drug.
According to a report in the New York Times, the Generic Pharmaceutical Association had “no comment.”
And that’s a shame – because this presents the manufacturers of generic medicines with a timely opportunity to step up to the plate and become a player (rather than a problem) when it comes to both cGMPs, quality, and safety.
Hopefully, upon return from the long weekend, generic drug manufacturers will embrace the FDA’s proposals.
We shall see.
You cannot escape the responsibility of tomorrow by evading it today.
-- Abraham Lincoln