On July 13, 2018, AMCP provided comments in response to FDA Final Guidance on Payor- Manufacturer communications. AMCP supported the need for timelier and more proactive
communications between biopharmaceutical manufacturers and population health decision makers. AMCP applauded the FDA for its leadership and recognition of the importance of
modernizing the provisions of the Food and Drug Administration Modernization Act (FDAMA) Section 114 as amended by Section 3037 of the 21st Century Cures Act (Cures) and the creation of a safe harbor for the exchange of preapproval communications.
Press Release: The Academy of Managed Care Pharmacy (AMCP) commends the U.S. Food and Drug Administration (FDA) for issuing final guidance that clarifies how manufacturers can communicate truthful and non-misleading information with payers across a product’s lifecycle.