The Honorable Mitch McConnell The Honorable Paul Ryan

Majority Leader Speaker

United States Senate U.S. House of Representatives
Washington, DC 20510 Washington, DC 20515

The Honorable Charles Schumer The Honorable Nancy Pelosi

Minority Leader Minority Leader
United States Senate U.S. House of Representatives
Washington, DC 20510 Washington, DC 20515

February 6, 2018

Dear Speaker Ryan and Leaders McConnell, Pelosi, and Schumer:

On behalf of the Institute for Liberty (IFL) and its supporters from coast to coast, I respectfully submit this letter in
support of the Creating and Restoring Equal Access to Equivalent Samples Act of 2017 (CREATES Act).

The Center for Health Security and Access of the Institute for Liberty is focused on ensuring that America's health care
system remains the best in the world, which means protecting the free market principles that have allowed Americans
to have access to our superior quality of treatment. IFL urges Congress to pass the CREATES Act to lower prescription
drug prices by encouraging market competition while protecting the safety of patients.

Since it was created in 2007, the Food & Drug Administration’s (FDA’s) Risk Evaluation and Mitigation Strategies (REMS)
program has been a critical mechanism for patient safety, ensuring that the benefits of a drug or biologic outweigh its
safety risk. FDA-mandated REMS programs serve a powerful public good by providing additional information to patients
and providers. Yet some brand companies have been exploiting a loophole in the law and abusing the REMS Elements to
Assure Safe Use (ETASU) requirements to prevent competition for products with and without required REMS programs.

The CREATES Act aims to stop the misapplication of REMS by bad actors to prevent or delay the market entry of lower-
cost generics and biosimilars. This bipartisan legislative remedy is narrow in its application, only addressing the specific
problem of REMS abuses. CREATES will not establish any new or onerous regulations on brand companies. On the
contrary, this legislation, if enacted, will support marketplace competition by allowing generic manufacturers to
purchase samples at market-based prices.

The CREATES Act is pro-patient and pro-market, and it is supported by a wide coalition of patient organizations and free-
market advocates. Congress must pass the CREATES ACT to take up what President Trump called a top priority in his
State of the Union: lowering prescription drug prices.

Thank you,

Andrew Langer
President