CCL has long been involved in efforts to protect the rights of plaintiffs injured by prescription drugs to pursue state tort remedies for their injuries and has aggressively opposed efforts by drug manufacturers to invoke federal preemption to shield them from such liability. In Pliva, Inc. v. Mensing, a case argued by CCL Senior Litigation Counsel Louis Bograd, the Supreme Court ruled, 5-4, that generic drug companies were largely immune from state failure-to-warn liability, because federal law prohibited them from adding new or strengthened warnings about their drugs without prior FDA approval. Now, after prolonged efforts by CCL, the American Association for Justice, and other advocates for injured plaintiffs, the FDA stands ready to overturn Mensing, at least prospectively, and effectively to restore plaintiffs’ rights. In a notice of proposed rulemaking published last week, FDA proposed revised regulations that would permit generic drug manufacturers to add new or strengthened warnings to their labels—and to send Dear Doctor letters about those changes—without prior agency approval, so long as the company simultaneously submits a supplemental application to the FDA seeking approval for the change. As the FDA notes, the proposed regulations would achieve “parity” between manufacturers of brand-name and generic drugs and thereby subject generic manufacturers to tort liability on the same basis as brand-name manufacturers. CCL will be working closely with AAJ and others to submit comments to FDA in support of the proposed regulations.