CREATES Act

U.S. law promoting generic drug competition

CREATES Act

The CREATES Act (Creating and Restoring Equal Access to Equivalent Samples Act) is a United States federal law enacted to promote competition in the pharmaceutical industry by facilitating the entry of generic drugs and biosimilars into the market. The act addresses certain anti-competitive practices by brand-name drug manufacturers that delay the approval and market entry of lower-cost alternatives.

Senator Patrick Leahy, a key proponent of the CREATES Act

Background

The CREATES Act was introduced in response to tactics used by some brand-name drug manufacturers to delay the entry of generic drugs. These tactics include refusing to provide samples of their products to generic manufacturers, which are necessary for the development and testing of generic versions. The act was designed to prevent such practices and ensure that generic manufacturers have the opportunity to compete fairly in the market.

Provisions

The CREATES Act includes several key provisions:

• Access to Samples: The act requires brand-name drug manufacturers to provide samples of their products to generic manufacturers under certain conditions. This is intended to prevent the use of Risk Evaluation and Mitigation Strategies (REMS) as a barrier to competition.

• Litigation Pathway: The act establishes a legal pathway for generic manufacturers to sue brand-name manufacturers if they refuse to provide samples. This provision aims to expedite the resolution of disputes and facilitate the timely entry of generics into the market.

• Penalties: The act imposes financial penalties on brand-name manufacturers that engage in anti-competitive practices, providing a deterrent against such behavior.

Impact

The CREATES Act is expected to lower drug prices by increasing competition in the pharmaceutical market. By facilitating the entry of generic drugs, the act aims to reduce the cost burden on consumers and the healthcare system. The Congressional Budget Office estimated that the act would save the federal government billions of dollars over a decade by reducing spending on prescription drugs.

Legislative History

The CREATES Act was introduced by Senator Patrick Leahy and garnered bipartisan support. It was included as part of a larger legislative package and signed into law in December 2019. The act was seen as a significant step towards addressing high drug prices and promoting fair competition in the pharmaceutical industry.

Related pages

• Generic drug
• Biosimilar
• Pharmaceutical industry
• Drug price competition