Legislation & Regulation

On September 18, 2023, the U.S. Food and Drug Administration (FDA) issued a draft guidance titled “Regulatory Considerations for Prescription Drug Use-Related Software”. This guidance describes how FDA intends to apply its drug-labeling authority to certain software outputs for use with a prescription drug or a prescription drug-led, drug-device combination product. In this guidance, prescription drug use related software generally includes software that (1) is disseminated by or on behalf of a drug sponsor and (2) produces an end-user output that supplements, explains, or is otherwise textually related to one or more of the sponsor’s drug products. FDA considers end-user output a type of prescription drug labeling. AMCP submitted comments in response to this guidance on December 18, 2023.

On October 4, 2023, the Department of Health and Human Services, the Department of Labor, and the Department of the Treasury issued a request for information titled “Coverage of Over-the-Counter Preventive Services”. This request is regarding the application of the preventive services requirements under the Public Health Service Act to over-the-counter (OTC) preventive items and services available without a prescription by a health care provider. Some examples could include certain types of tobacco cessation pharmacotherapy, folic acid supplements, breastfeeding supplies, and contraceptives such as a recently approved OTC progestin-only daily oral contraceptive. Additional recommended preventive products may become available OTC in the future. AMCP submitted comments in response to the proposed rule on December 4, 2023.

Patients need to be aware of the dangers of fake medicines, potentially causing disease progression, adverse events, and even death. AMCP supports the joint statement released by National Association of Boards of Pharmacy and other health care organizations on fighting fake medicines bought online.

On September 18, 2023, the Office of Management and Budget (OMB) issued the draft guidance titled “Advancing Governance, Innovation, and Risk Management for Agency Use of Artificial Intelligence”. While AI is improving operations and efficiency across the Federal Government, agencies must effectively manage its use. As such, this memorandum establishes new agency requirements and guidance for AI governance, innovation, and risk management, including through specific minimum risk management practices for uses of AI that impact the rights and safety of the public. The document focuses on three main pillars: .Strengthening AI governance; .Advancing responsible AI innovation; and .Managing risks from the use of AI by directing agencies to adopt mandatory safeguards for the development and use of AI that impacts the rights and safety of the public. AMCP submitted comments in response to the proposed rule on December 1, 2023.

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.