The Creating and Restoring Equal Access to Equivalent Samples Act of 2017 (CREATES Act) protects the free- market principles that have allowed Americans to have access to our superior quality of treatment. Congress should 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 2018 State of the Union: lowering prescription drug prices