What is FDAMA 114?
FDAMA 114 refers to part of the FDA Modernization Act which calls on FDA to provide guidance to pharma companies on the communication of healthcare economic information (HCEI) with population health decisionmakers (PHDMs) including payers. The 21st Century Cures Act further built on the initial legislation and has led to multiple guidances from FDA on the appropriate communication of HCEI with PHDMs including what types of information are appropriate, when it is okay to proactively communicate certain information as well as what it is not okay to communicate.
As payers find it useful to understand drug-specific data, economic projections, indication prevalence, etc. prior to a drug’s approval, these guidances have allowed pharma companies to better provide these key data to their payer customers. Despite the guidance, there are still areas which are unclear.