The Op-Ed: The FDA Should Not Change Generic Labeling Rules

Last week, the FDA proposed a rule to revise regulations that prevent generic drugmakers from updating labeling, even if they become aware of a potential risk not mentioned in labeling. By contrast, brand-name drugmakers can update labeling before obtaining FDA approval. The proposal was made in response to a US Supreme Court ruling that generic drugmakers are not required to update product labeling, even when alerted to side effects, so long as the same change has not been made to the labeling for the branded medicine (the case was known as Pliva vs. Mensing). The decision sparked an outcry that product labeling would be insufficient to warn patients about the risks associated with numerous medications. And so, the FDA proposal was hailed by consumer advocates but riled generic drugmakers, who expect to face greater product liability litigation. Bob Pollock, a senior advisor at Lachman Consultants, which works with generic drugmakers, and a former acting deputy director at the FDA Office of Generic Drugs, muses on the implications of the FDA proposal… Is There Litigation After Mensing? I am afraid so, especially if the rule the FDA proposed on label changes for generic applicants become final (back story with link to the Federal Register notice). Having been around the block a few times on this issue as an expert witness, as a licensed pharmacist and as former Acting Deputy Director of the Office of Generic Drugs, I hold what one might call strong opinions on this issue. ...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs