Review Voucher Program For Rare Pediatric Diseases Should Not Be Reauthorized, FDA Says
This article was originally published in The Pink Sheet Daily
Marketing exclusivity may be better way to go, FDA tells GAO, citing workload burdens and lack of evidence that vouchers have incentivized development of new treatments.
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US incentive program would gain only four more years, despite calls for a permanent extension.
Chair of the House Energy and Commerce Committee raises questions about the priority review voucher program’s value, suggesting another limited extension may be upcoming.
Rare Pediatric Disease Designations May Be Unavailable After July As Program Renewal Remains Uncertain
Without new legislation, US FDA said that designations, which are required to receive priority review vouchers, cannot be assured if requested after July. While the window for designations formally closes at the end of September when the authorization of the program expires, the agency is telling sponsors that it needs 60 days before that to review any requests. If a product does get a designation, it would need to secure approval by 30 September 2022 to gain a priority review voucher.