S. 1878 would amend and extend an incentive program administered by the Food and Drug Administration (FDA) that awards priority review vouchers to companies for obtaining FDA approval for drugs and biologics that target rare pediatric diseases. Such vouchers allow a recipient to receive expedited FDA review of a future drug application. CBO estimates that implementing S. 1878 would cost $12 million over the 2017-2021 period, assuming appropriation of the necessary amounts. Pay-as-you-go procedures do not apply to the bill because enacting it would not affect direct spending or revenues.
CBO estimates that enacting S. 1878 would not increase net direct spending or on-budget deficits in any of the four consecutive 10-year periods beginning in 2027.
S. 1878 contains no intergovernmental or private-sector mandates as defined in the Unfunded Mandates Reform Act and would not affect the budgets of state, local, or tribal governments.
