As reported by the Senate Committee on Health, Education, Labor, and Pensions on May 14, 2018
S. 2315 would change the oversight of the commercial marketing of over-the-counter (OTC) medicines by the Food and Drug Administration (FDA). The bill would authorize the collection and spending of fees through 2023 to cover the costs of expediting the FDA’s administrative procedures for certain regulatory activities relating to OTC products. Such fees could be collected and made available for obligation only to the extent and in the amounts provided in advance in appropriation acts.
Assuming appropriation actions consistent with the bill, CBO estimates that implementing S. 2315 would increase fee collections and related spending. Over the 2019-2023 period, spending would lag collections by $10 million.
S. 2315 also would grant two years of exclusive market protection for certain qualifying OTC drugs, thus delaying the entry of other versions of the same qualifying OTC product. Because Medicaid currently provides some coverage for OTC medicines, and such delays could affect the average net price paid by Medicaid, that provision could affect direct spending; therefore, pay-as-you go procedures apply. CBO estimates that the effect on Medicaid spending would be negligible over the 2019-2028 period. Enacting the bill would not affect revenues.
CBO estimates that enacting S. 2315 would not increase net direct spending or on-budget deficits in any of the four consecutive 10-year periods beginning in 2029.
S. 2315 would impose a private-sector mandate as defined in the Unfunded Mandates Reform Act (UMRA) by requiring developers and manufacturers of OTC products to pay certain fees to the FDA. CBO estimates that the costs of the mandates would not exceed the annual threshold for private-sector mandates ($160 million in 2018, adjusted annually for inflation) in any year during that period.
The bill contains no intergovernmental mandates as defined in UMRA.