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1 H.R. 2375, Preserve Access to Affordable Generics and Biosimilars Act 1 (May 8, 2019)

handle is hein.congrec/praffg0001 and id is 1 raw text is: Congressional Budget Office Cost Estimate May 8, 2019 By Fiscal Year, Milions of Dollars 2019 2019=2024 2019o2029 Direct Spending (Outlays) Revenues Deficit Effect -193 0 0 -520 34 -227 93 -613 H.R. 2375 would make certain agreements-used to settle claims of patent infringement between sponsors of brand-name, generic, or biosimilar drugs and relating to the sale of a drug or biological product-presumptively illegal under antitrust law. The bill would require particular types of agreements arising from proceedings conducted by the Patent Trial and Appeal Board (PTAB) to be reported to Federal Trade Commission (FTC) and the Department of Justice (DOJ). H.R. 2375 also would establish the authority to impose civil penalties when a party to a settlement is found to have violated the bill's requirements. CBO expects that the bill would accelerate the availability of lower-priced generic or biosimilar drugs that would have been affected by agreements targeted by the bill and reduce the average price of drugs paid by federal health programs that purchase drugs or provide health insurance that covers drugs. In total, CBO estimates that enacting H.R. 2375 would decrease the deficit by $613 million over the 2019-2029 period. That amount includes a $520 million reduction in direct spending and a $93 million increase in revenues. CBO also estimates that implementing H.R. 2375 would decrease spending subject to appropriation by $24 million over the 2019-2024 period, assuming appropriation actions consistent with the bill. That decrease would result primarily because lower estimated drug prices would reduce costs for discretionary health programs. See also CBO's Cost Estimates Explained, wwwcbo.gov/publication /54437; How CBO Prepares Cost Estimates, www.cbo.gov/publication/53519; and Glossary, www.cbo~gov/publication/42904.

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