FDAMA 114 and the 21st Century Cures Act

The 21st Century Cures Act was signed into law on December 13, 2016. The stated aim of the legislation is to modernize and personalize healthcare, encourage innovation, support research, and streamline the US healthcare system to promote the delivery of better and faster “cures” to more patients. The Act has four major sections, or titles. The first three —“Discovery,” “Development,” and “Delivery”— track the sequence of how medical innovations reach patients. The fourth title, “Medicaid, Medicare, and Other Reforms,” itemizes the activities to pay for the cost of the legislation. Title II, “Development”, includes a provision on pharmaceutical manufacturers’ promotion of health care economic information (HCEI). The Act makes changes to Section 114 of the Food and Drug Modernization Act of 1997 (FDAMA 114), providing clarity and flexibility for manufacturers to communicate HCEI to “a payer, formulary committee or other similar entity” responsible for “the selection of drugs for coverage or reimbursement”. This symposium provided a brief overview of the 21st Century Cures Act, with a focus on the provision to facilitate dissemination of HCEI. Insights from US payers and pharmaceutical manufacturers on the implications of the 21st Century Cures Act on the exchange of HCEI was shared and discussed in further detail during the symposium.