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FDA Action Plan To Speed Up Drug Development For Rare Neurodegenerative Diseases

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The U.S. Food and Drug Administration unveiled its action plan to advance drug development for rare neurodegenerative diseases, including Amyotrophic Lateral Sclerosis or ALS, in five years.

The FDA plans specific actions such as regulatory science initiatives, enhancements to existing programs and new policy initiatives for the purpose. It will use public-private partnerships and direct involvement of patients.

FDA Commissioner Robert Califf stated that the action plan will ensure the agency meets the task issued by Congress of facilitating access to new therapies to improve the quality of life.

The plan has been developed in accordance with the provisions of the Accelerating Access to Critical Therapies for ALS Act, or ACT for ALS, which President Biden signed into law on December 23, 2021.

Under its five-year strategy, the FDA will focus on engaging in targeted activities, such as establishing the FDA Rare Neurodegenerative Diseases Task Force as well as public-private partnership for rare neurodegenerative diseases, both by fiscal 2022. The agency will also develop disease-specific science strategies between fiscal 2022 and 2026, and leverage ongoing FDA regulatory science efforts.

The plan also includes the ALS Science Strategy, which provides a forward leaning framework for FDA activities to assess key regulatory science priorities. The activities will include patient engagement, public workshops, research projects, coordination across FDA centers and offices and collaboration with the National Institutes of Health or NIH.

ACT for ALS also requires the Department of Health and Human Services or HHS to implement a Public-Private Partnership for Neurodegenerative Diseases between NIH, FDA and one or more outside entities.

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