
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, L ...
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 g ...
in the House of Representatives, those bills were incorporated into the
Further Consolidated Appropriations Act, 2020 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
Congressional Budget Office
The Congressional Budget Office (CBO) is a federal agency within the legislative branch of the United States government that provides budget and economic information to Congress.
Inspired by California's Legislative Analyst's Office that manag ...
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 ...
of
Texas
Texas (, ; Spanish language, Spanish: ''Texas'', ''Tejas'') is a state in the South Central United States, South Central region of the United States. At 268,596 square miles (695,662 km2), and with more than 29.1 million residents in 2 ...
and
Mike Lee
Michael Shumway Lee (born June 4, 1971) is an American lawyer and politician serving as the senior United States senator from Utah, a seat he has held since 2011. He is a member of the Republican Party.
Lee began his career as a clerk for the U ...
of
Utah
Utah ( , ) is a state in the Mountain West subregion of the Western United States. Utah is a landlocked U.S. state bordered to its east by Colorado, to its northeast by Wyoming, to its north by Idaho, to its south by Arizona, and to its ...
. Liberal Democrat senators have also voiced support of the bill including Senators
Dianne Feinstein
Dianne Goldman Berman Feinstein ( ; born Dianne Emiel Goldman; June 22, 1933) is an American politician who serves as the senior United States senator from California, a seat she has held since 1992. A member of the Democratic Party, she was ...
of
California
California is a state in the Western United States, located along the Pacific Coast. With nearly 39.2million residents across a total area of approximately , it is the most populous U.S. state and the 3rd largest by area. It is also the ...
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 ...
of
Rhode Island
Rhode Island (, like ''road'') is a state in the New England region of the Northeastern United States. It is the smallest U.S. state by area and the seventh-least populous, with slightly fewer than 1.1 million residents as of 2020, but i ...
. The bill was also supported by prominent think tanks including conservative groups
Heritage Action and
FreedomWorks
FreedomWorks is a conservative and libertarian advocacy group based in Washington, D.C. FreedomWorks trains volunteers, assists in campaigns, and encourages them to mobilize, interacting with both fellow citizens and their political representa ...
, as well as liberal think tanks
Families USA and
Public Citizen
Public Citizen is a non-profit, progressive consumer rights advocacy group and think tank based in Washington, D.C., United States, with a branch in Austin, Texas.
Lobbying efforts
Public Citizen advocates before all three branches of the Uni ...
.
Public surveys found 75% of
Americans
Americans are the citizens and nationals of the United States of America.; ; Although direct citizens and nationals make up the majority of Americans, many dual citizens, expatriates, and permanent residents could also legally claim Amer ...
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