Published: February 2019

The CREATES Act protects patients from outrageous prescription drug costs

When it comes to prescription medicines, patients win when companies innovate new cures and treatments. Patients also win when more affordable generic versions of those medicines enter the market. Unfortunately, some drug manufacturers aren’t playing by the rules.

Prescription drug manufacturers take advantage of loopholes in Food and Drug Administration (FDA) safety programs to artificially extend their monopolies and keep generic versions of their product from coming to market. The result: patients are left with few options and the U.S. healthcare system spends billions of dollars a year. The Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act seeks to stop drugmakers that withhold samples of their medicines from generic makers in an effort to delay or prevent generics from coming to market.

Consumer Action joined other health and consumer advocates in urging Congress to support the CREATES Act. The bill allows a drug company to bring a civil action against an innovator drug company if the latter refuses to make available enough samples of a product for testing so that a biosimilar or generic can be developed.

Lead Organization

Association for Accessible Medicines (AAM)

Other Organizations

AARP | Academy of Managed Care Pharmacy | AFL-CIO | Alliance of Community Health Plans | Alliance for Retired Americans | American Academy of Dermatology Association | American Academy of Family Physicians | American College of Physicians | American Consumer Institute | American Gastroenterological Association | America’s Health Insurance Plans | American Hospital Association | Anthem | ASHP | Association for Accessible Medicines | Black Women’s Health Imperative | Blue Cross Blue Shield Association | Blue Cross Blue Shield of Arizona | Blue Cross Blue Shield of Michigan | Blue Shield of California | Campaign for Sustainable Rx Pricing | Center for Freedom and Prosperity | Coalition for Affordable Prescription Drugs | Coalition to Reduce Spending Consumer Action | Consumer Reports | CVS Health | Doctors for America | Families USA | Federation of American Hospitals | FreedomWorks 3

More Information

For more information, please visit AAM's website.

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The CREATES Act protects patients from outrageous prescription drug costs   (FINALCREATESAct_2.5.19.pdf)