NHC Comments on Administering the Hatch-Waxman Amendments: Ensuring a Balance between Innovation and Access

The National Health Council (NHC) appreciates the opportunity to provide comments on the administration of the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act). Patients with chronic diseases and disabilities rely on both the innovation that produces new life-saving treatments and the ability to access lower-cost alternatives to these innovator drugs. As such, the NHC recognizes the value of finding the right balance between encouraging innovation and timely entry of generics into the market, and shares concerns that misuse of certain regulatory processes can and have upset this delicate balance. We applaud the FDA’s efforts to evaluate how the Hatch-Waxman Amendments are working today and consider potential ways to refine its policies and procedures to alleviate or minimize disruption to the efficient and timely market entry of generics.  

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Date: 
Friday, November 17, 2017