Executive Director Amanda Malakoff and Lisa Feng, the Senior Director of Policy at Alexion, AstraZeneca Rare Disease (an RDCC member company) joined the Vital Health Podcast with Duane Schulthess for a discussion on the accelerated approval pathway for rare disease treatment development.
Recent proposed federal and state policies to restrict coverage and access to biomedical innovations approved through the FDA’s accelerated approval pathway would harm patient access to rare disease treatments. Vital Transformation completed a comprehensive impact assessment of these proposed changes and what they could mean for patients currently lacking treatments and future innovations. According to this research, up to 66% of accelerated approval treatments could be at high-risk of not coming to market or being developed at all if the FDA’s accelerated approval pathway were negatively impacted.
Listen below for the full discussion and click here for more information on why protection of the accelerated approval pathway for rare disease treatment is urgently needed.