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On September 18, 2023, the U.S. Food and Drug Administration (FDA) issued the draft guidance titled “Labeling for Biosimilar and Interchangeable Biosimilar Products”.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.
The world of prescription drug care and coverage can be complicated. Read AMCP CEO Susan Cantrell’s blog on AMCP’s inaugural “Access, Affordability, & Outcomes: The Value of Managed Care Pharmacy” annual report to learn how we’re making it more understandable
On Aug. 30, 2023, the Department of Health and Human Services, the Department of Labor, and the Department of the Treasury issued the proposed rule titled “Requirements Related to the Mental Health Parity and Addiction Equity Act. AMCP submitted comments in response to the proposed rule on Oct. 17.
With October devoted to National Pharmacy Awareness, AMCP CEO Susan Cantrell talks about the outstanding efforts of managed care pharmacists across the United States in her latest blog.
The Biologics & Biosimilars Collective Intelligence Consortium (BBCIC) today announced that it has been awarded a $1.4 million grant from the Food & Drug Administration (FDA) to enable biosimilar research.
On August 21, 2023, CMS Issued the Maximum Monthly Cap on Cost-Sharing Payments Under Prescription Drug Plans: Draft Part One Guidance on Select Topics, Implementation of Section 1860D-2 of the Social Security Act for 2025. The purpose of this document is to provide interested parties with draft part one guidance on a select set of topics for the Maximum Monthly Cap on Cost-Sharing Payments Program.