CREATES Act
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The CREATES Act of 2019 is a U.S. federal law which includes measures intended to reduce prices and increase the competitiveness of generic pharmaceutical drugs. Originally standalone legislation sponsored by Patrick Leahy in the Senate and David Cicilline in the House of Representatives, those bills were incorporated into the Further Consolidated Appropriations Act, 2020[1] which was signed into law on December 20, 2019.
The bill had been drafted in some form since 2016.[2] Measures in the bill are intended to prevent pharmaceutical companies from blocking companies from producing generic drugs by refusing to sell drugs to the new companies, or taking advantage of safety regulation to block new drugs. Generic drug companies would be allowed to sue to gain access to samples.[3] The resulting impact of the bill would be a reduction in generic drug prices via increased market competition.[4]
The Congressional Budget Office estimated that the bill would save $3.8 billion over a 10-year period by reducing drug prices for Medicare and Medicaid.[3]
The bill was intended for inclusion in the February 2018 budget package. However, as a result of lobbying from pharmaceutical companies and other opposition, the provision was removed from the final budget provision.[5]