S. 185 would require the Food and Drug Administration (FDA) to establish a program to approve certain antibacterial drugs for a limited population of patients with unmet needs. The bill also would require FDA to study the effectiveness of the new program. CBO estimates that implementing S. 185 would cost $27 million over the 2017-2021 period, assuming appropriation of the necessary amounts. Pay-as-you-go procedures do not apply because enacting S. 185 would not affect direct spending or revenues.
CBO estimates that enacting S. 185 would not increase net direct spending or on-budget deficits in any of the four consecutive 10-year periods beginning in 2027.
S. 185 contains no intergovernmental or private-sector mandates as defined in the Unfunded Mandates Reform Act.