Generic Drug Labeling Proposed Rule and Safety Updates

Recent rulings in the Supreme Court cases of Pliva v Mensing (2011) and Mutual Pharmaceuticals v. Bartlett (2013) have resulted in a legal loophole favoring generic manufacturers. Federal labeling regulations were found to preempt state tort suits against generic manufacturers, thereby disenfranchising the rights of consumers to seek legal action if generic labeling does not adequately reflect safety warnings. In the pursuit of public health, the FDA released a press announcement in November 2013 on a proposed rule that would “speed the dissemination of new safety information about generic drugs to health professionals and patients by allowing generic drug makers to use the same process as brand drug manufacturers to update safety information in the product labeling.”

This new rule would close this legal loophole to ensure consumer safety but would result in a significant change to the regulatory practices of the pharmaceutical industry. This webinar will focus on the expectations of the proposed rule and the potential impact it will have from the brand and generic perspectives.