On May 9 and May 17, 2018, the House Committee on Energy and Commerce ordered 59 bills to be reported related to the nation’s response to the opioid epidemic. Because of the large number of related bills ordered reported by the Committee, CBO is publishing a single comprehensive document that includes estimates for each piece of legislation.
H.R. 5333, the Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018, would change the way that the Food and Drug Administration (FDA) regulates the marketing of over-the-counter (OTC) medicines, and it would authorize that agency to grant 18 months of exclusive market protection for certain qualifying OTC drugs, thus delaying the entry of other versions of the same qualifying OTC product. Medicaid currently provides some coverage for OTC medicines, but only if a medicine is the least costly alternative in its drug class. On the basis of stakeholder feedback, CBO expects that delaying the availability of additional OTC versions of a drug would not significantly affect the average net price paid by Medicaid. As a result, CBO estimates that enacting H.R. 5333 would have a negligible effect on the federal budget. (If enacted, H.R. 5333 also would affect spending subject to appropriation.)
H.R. 5333 would change the FDA’s oversight of the commercial marketing of OTC medicines and 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. Under H.R. 5333, CBO estimates, the FDA would assess about $147 million in fees over the 2019-2023 period that could be collected and made available for obligation only to the extent and in the amounts provided in advance in appropriation acts. Because the FDA could spend those fees, CBO estimates that the estimated budget authority for collections and spending would offset each other exactly in each year, although CBO expects that spending initially would lag behind collections. Assuming appropriation action consistent with the bill, CBO estimates that implementing H.R. 5333 would reduce net discretionary outlays by $10 million over the 2019-2023 period, primarily because of that lag. The bill also would require the Government Accountability Office to study exclusive market protections for certain qualifying OTC drugs authorized by the bill—a provision that CBO estimates would cost less than $500,000. (If enacted, H.R. 5333 also would affect mandatory spending.)
H.R. 5333 would require developers and manufacturers of OTC drugs to pay certain fees to the FDA. CBO estimates that about $30 million would be collected each year, on average, for a total of $147 million over the 2019-2023 period. Those amounts would not exceed the annual threshold for private-sector mandates in any year during that period.
H.R. 5333 would impose private-sector mandates as defined in UMRA. CBO estimates that the costs of the mandates would not exceed the UMRA threshold for private entities.
