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.
Overview from July 2018. One of AMCP’s policy and advocacy focus areas for 2018 is Opioid Management. AMCP has been actively involved on the federal and state levels to increase awareness of the role of managed care pharmacy in support of patient-centered and clinically effective approaches to reduce overuse, diversion, and
On February 1, 2018, CMS released its 2019 Draft Call Letter. AMCP prepared in initial summary of the highlights contained in the Draft Call Letter. Of particular interest to AMCP members, CMS proposed new strategies for identifying potential opioid abuse which will work with the proposed codification of the current Opioid Monitoring System (OMS) under the Comprehensive Addiction and Recovery Act of 2015 (CARA).