Proposed federal and state policies to restrict coverage and access to biomedical innovations approved through the FDA’s accelerated approval pathway are setting off alarms among rare disease advocates. That's because accelerated approvals are a vitally important pathway for faster, reliable drug development to meet the unmet needs of people with rare diseases.

Vital Transformation completed a comprehensive impact assessment of these proposed changes and what they could mean for patients currently lacking treatments and future innovations. In this Vital Health Podcast, Duane Schulthess takes a deep dive into those findings, joined by Amanda Malakoff, the Executive Director of the Rare Disease Company Coalition and Lisa Feng, the Senior Director of Policy at Alexion, AstraZeneca Rare Disease.

Topics of discussion include the detrimental impacts of radical changes to the use of surrogate endpoints, and the virtually nonexistent impacts of accelerated approved medicines on state Medicaid budgets.