Medicaid Medical Directors Network: Perspectives on the FDA Accelerated Approval Program
This paper outlines two policy recommendations for revisions to the FDA Accelerated Approval Program which promote clinical advances while being mindful of financial oversight.
Policymakers, specifically Medicaid Medical Directors, are concerned about the high premium for medications that lack demonstrated improvement of patient health outcomes. This paper, from AcademyHealth’s Medicaid Medical Directors Network (MMDN), provides an overview of the FDA’s Accelerated Approval Program for policymakers, elected officials, health care providers, patients and the public-at-large. It highlights the increasingly negative fiscal impact of high-cost drugs vetted through the process and the ways these costs jeopardize the sustainability of other essential Medicaid health benefits. The paper offers the following two policy recommendations designed to enhance the existing drug approval program:
- That the FDA hold drug approvals to high evidentiary standards and address issues related to transparency and cost shifting in the accelerated approval process.
- That Medicaid programs have their federal obligation in the pharmacy benefit limited to coverage of only proven, effective, non-experimental, and non-investigative drugs; if coverage of these drugs is required, Medicaid programs should have added federal financial support.
The paper does not reflect the policy positions of any individual member of the MMDN, AcademyHealth or any supporting organizations.