November 2023 Legislative & Regulatory Briefing: AMCP’s Adam Colborn Gives a Legislative, Regulatory, and Judiciary Update on Trending Topics in the Pharmacy Space; AMCP Comments on Requirements Related to the Mental Health Parity and Addiction Act; Now Available: Key Takeaways from AMCP’s Aug. 2 IRA Workshop Kickoff; AMCP Comments on Discrimination on the Basis of Disability in HHS Programs or Activities; AMCP Celebrates America’s Managed Care Pharmacists During National Pharmacy Month; Register Now: Access, Affordability, and Outcomes: The Value of Managed Care Pharmacy Webinar.
On May 30, 2023, Food and Drug Administration (FDA) issued the proposed rule titled “Medication Guides: Patient Medication Information”. The purpose of this rule is to amend its human prescription drug product labeling regulations for Medication Guides (FDA approved written prescription drug product information distributed to patients). This action, if finalized, will require applicants to create a new type of Medication Guide, referred to as Patient Medication Information (PMI), for prescription drug products, including biological products, used, dispensed, or administered on an outpatient basis and for blood and blood components transfused in an outpatient setting. AMCP submitted comments in response to the proposed rule on November 27, 2023.
On September 18, 2023, the U.S. Food and Drug Administration (FDA) issued the draft guidance titled “Labeling for Biosimilar and Interchangeable Biosimilar Products”. AMCP submitted comments in response to the proposed rule on November 17, 2023.
Last week, AMCP hosted its second IRA workshop, convening stakeholders to help unpack the complexities of the Inflation Reduction Act and discuss what’s on the horizon. In her latest blog, AMCP CEO Susan Cantrell reflects on the takeaways.
On September 14, 2023, the Department of Health and Human Services (HHS) and the Office for Civil Rights issued the proposed rule titled “Discrimination on the Basis of the Disability in Health and Human Service Programs or Activities". AMCP submitted comments in response to the proposed rule on November 13, 2023.
Nearly 3,000 managed care professionals from health plans, PBMs, pharmaceutical manufacturers, and other managed care organizations convened in Orlando from Oct. 16–19 for AMCP Nexus 2023, the industry’s premier fall meeting.