With bipartisan support, Congress is moving forward with the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act, which aims to expand market opportunities for generic drugs.
The legislation addresses existing laws that make it more difficult for generics to enter the market, says Rachel Schwartz, communications director of the Association for Accessible Medicines, a generic drug industry trade group.
“In about 2007, Congress passed a law that required certain FDA-approved drugs to be more closely monitored to make sure the benefits outweighed the risks,” said Schwartz. The FDA created the Risk Evaluation and Mitigation Strategy (REMS), a drug safety program that the U.S. Food and Drug Administration (FDA) can require for certain medications.
