The Academy of Managed Care Pharmacy (AMCP) thanks the Food and Drug Administration (FDA) for the opportunity to provide comments in response to the “Expedited Program for Serious Conditions — Accelerated Approval of Drugs and Biologics” (Draft Guidance), issued on December 5, 2024.
AMCP is the nation’s leading professional association dedicated to increasing patient access to affordable medicines, improving health outcomes, and ensuring the wise use of healthcare dollars. Through evidence and value-based strategies and practices, AMCP’s nearly 8,000 pharmacists, physicians, nurses, and other practitioners manage medication therapies for the 270 million Americans served by health plans, pharmacy benefit management firms, emerging care models, and government health programs.
Accelerated approval is an important topic for managed care organizations (MCOs). Providing access to medications for patients is vital. Manufacturers and MCOs alike want to provide access to medications to help patients with unmet medical needs as early as possible. At the same time, MCOs need greater certainty about safety and efficacy and may find that available clinical data falls short. MCOs may face financial risk for covering products subject to accelerated approval, especially if these products prove not to be effective.
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