Pediatric priority review voucher program on the brink

Rare disease advocates and biopharma companies are intensifying efforts to persuade Congress to reauthorize a law requiring FDA to grant priority review vouchers for medicines to treat rare pediatric diseases. They are racing against a September 30 deadline when the Creating Hope Act will sunset in the absence of congressional action.

Efforts to prevent expiration of the pediatric PRV program are complicated by the congressional calendar, which provides members a summer break that is far more generous than the vacations most voters enjoy, and by campaign season politics that overshadow everything in Congress and at the White House...