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H.R. 10359

BillFederalHouseIn Committee
To amend the Federal Food, Drug, and Cosmetic Act to permanently extend the authority of the Secretary of Health and Human Services to award priority review vouchers for rare pediatric disease products.
About This Bill
Committee
Latest Action · September 14, 2026
Referred to the House Committee on Energy and Commerce.
Introduced
September 14, 2026
Cosponsors (6)
4D 2R
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Summary

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This bill makes permanent the authority of the Food and Drug Administration to award priority review vouchers to pharmaceutical companies that develop treatments for rare diseases affecting children. Priority review vouchers allow companies to move their drug applications to the front of the FDA's review line, which typically accelerates the approval process from ten months to six months. The legislation removes an expiration date on this voucher program, which was previously set to sunset, ensuring the incentive remains available indefinitely to encourage continued investment in pediatric rare disease treatments. The bill directly affects pharmaceutical companies and pediatric patients with rare diseases by maintaining a key incentive that helps bring lifesaving treatments to market faster. This measure has no direct federal funding requirements, as it operates through the existing FDA review process.

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