Comment from Pharmaceutical Research and Manufacturers of America (PhRMA)

Summary: PhRMA, representing leading biopharmaceutical research companies, opposes the Outsourcing Facilities Association's (OFA) nomination of bulk drug substances for the 503B Bulks List. They argue that the OFA's "en bloc" nomination lacks specific evidence of clinical need, poses significant patient safety risks, and undermines the integrity of the FDA's drug approval process.