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On September 18, 2023, the U.S. Food and Drug Administration (FDA) issued the draft guidance titled “Labeling for Biosimilar and Interchangeable Biosimilar Products”.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.

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.

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.

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.

On June 22, CMS unveiled proposed guidance titled "Coverage with Evidence Development." Given AMCP's commitment to addressing health disparities in medication use and access, AMCP submitted comments in response to the proposed guidance on Aug. 21.

On July 25, 2023, AMCP commented on the Medicaid Program; Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program [CMS-2434-P].