Legislation would make pediatric Priority Review voucher program permanent

Members of the congressional Childhood Cancer Caucus have introduced legislation that would reauthorize the Creating Hope Act, making permanent the FDA’s rare pediatric disease Priority Review voucher program.

Reps. G.K. Butterfield (D-N.C.), Mike Kelly (R-Penn.), Michael McCaul (R-Texas) and Jackie Speier (D-Calif.) are co-sponsoring the Creating Hope Reauthorization Act. The bill would remove sunset provisions in the 21st Century Cures Act of 2016, which reauthorized the rare pediatric disease voucher program through Sept. 30, 2020. However, if a drug application is designated for a pediatric rare disease by that date and is approved by Sept. 30, 2022, a voucher can still be issued. ...