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Last month, Congress reauthorized critical user fee programs at the Food and Drug Administration (FDA), which fund more than half of the FDA's budget and are vital for our rare disease community. Unfortunately, other crucial programs and reforms that are important to the rare disease community which we've been calling for were left out and still require Congress to take action.
Contact your Members of Congress TODAY and urge them to support inclusion of the following programs and reforms to improve research and development for rare diseases treatments in any end-of-year spending bill:
- Authorize the Orphan Products Grants Program for five years, and other programs important to rare disease patients.
- Clarify how orphan drug exclusivity is awarded to avoid confusion and uncertainty that could delay critical products being approved by the FDA.
- Strengthen FDA's accelerated approval pathway to ensure health care providers and insurance companies continue to have confidence in drugs approved through this critical pathway.
- Ensure increased representation of diverse and underserved populations in clinical trials supporting FDA-approved drugs and medical devices.
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