The Coalition for Affordable Prescription Drugs (CAPD), a diverse group of employers, labor unions, pharmacy benefit managers (PBMs), health plans, and state employees and retirees, today issued the following statement in response to remarks made this morning by U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb at the Politico PRO Summit:
“CAPD commends Commissioner Gottlieb for his commitment to release an Agency action plan to spur development of generic versions of biologic drugs. For too long, brand-name pharmaceutical companies have ‘gamed the system’ by denying generic manufacturers access to the samples required to conduct necessary equivalence testing to ensure the quality, efficacy, and safety of a generic drug.
“This, combined with other anticompetitive practices, has allowed brand-name drug manufacturers to stifle generic competition, inflating prescription drug prices by artificially extending their monopoly pricing power far beyond the exclusivity period intended by Congress. This anticompetitive conduct harms not only the patients who depend on these drugs, but results in an enormous and unnecessary burden on the healthcare system as a whole. We look forward to reviewing the Commissioner’s forthcoming plan.”