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 Patrick Joseph Leahy (; born March 31, 1940) is an American politician and attorney who is the senior United States senator from Vermont and serves as the president pro tempore of the United States Senate. A member of the Democratic Party, ...

in the Senate and

David Cicilline David Nicola Cicilline (; born July 15, 1961) is an American lawyer and politician serving as the U.S. representative for since 2011. A member of the Democratic Party, he was the 36th mayor of Providence from 2003 to 2011, the first openly ...

in the House of Representatives, those bills were incorporated into the

Further Consolidated Appropriations Act, 2020 The United States federal budget for fiscal year 2020 ran from October 1, 2019 to September 30, 2020. The government was initially funded through a series of two temporary continuing resolutions. The final funding package was passed as two con ...

which was signed into law on December 20, 2019. The bill had been drafted in some form since 2016. 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. The resulting impact of the bill would be a reduction in generic drug prices via increased market competition. The

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estimated that the bill would save $3.8 billion over a 10-year period by reducing drug prices for Medicare and Medicaid.

History

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.

Support

The bill had support from conservatives including Senators

Ted Cruz Rafael Edward "Ted" Cruz (; born December 22, 1970) is an American politician and attorney serving as the junior United States Senator from Texas since 2013. A member of the Republican Party, Cruz served as Solicitor General of Texas from ...

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and

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. Liberal Democrat senators have also voiced support of the bill including Senators

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and

Sheldon Whitehouse Sheldon Whitehouse (born October 20, 1955) is an American lawyer and politician serving as the junior United States senator from Rhode Island since 2007. A member of the Democratic Party, he served as a United States Attorney from 1993 to 1998 ...

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. The bill was also supported by prominent think tanks including conservative groups

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and

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, as well as liberal think tanks

Families USA Families USA is a nonprofit, nonpartisan consumer health advocacy and policy organization. Co-founded founded in 1981 by Ronald Pollack, the first executive director, and Philippe Villers, the organization's current president, Families USA's advo ...

and

Public Citizen Public Citizen is a non-profit, Progressivism in the United States, progressive consumer rights advocacy group and think tank based in Washington, D.C., United States, with a branch in Austin, Texas, Austin, Texas. Lobbying efforts Public Citizen ...

. Public surveys found 75% of

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said the President and Congress "need to do more" to reduce drug prices, while around 10% of those surveyed said that they think that they have done enough.

Opposition

The CREATES Act was opposed by Pharmaceutical Research and Manufacturers of America (PhRMA). Opponents said the bill was not good solution to the issue of Risk Evaluation Mitigation Strategy with Elements to Assure Safe Use, or "REMS with ETASU" processes. These programs can include physician training, patient registries or follow-up testing.

References

{{Reflist Proposed legislation of the 115th United States Congress