On September 18, 2023, the Office of Management and Budget (OMB) issued the draft guidance titled “Advancing Governance, Innovation, and Risk Management for Agency Use of Artificial Intelligence”.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.
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.
Host Fred Goldstein invites Charles Makin, Global HEOR, RWE and Market Access Advisor to discuss their poster at AMCP Nexus 2023 on RWE adoption by US Payers.
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.
Host Fred Goldstein invites Dr. Emmanuel Mensah, a Firm Chief and Faculty at Beth Israel Deaconess Medical Center / Harvard Medical School to discuss taking a look in the mirror and reflect on our own implicit biases and disparities in health care.