More less-expensive, generic drugs would hit the market under a bipartisan bill being considered by a Senate panel Thursday.
The bill, known as the Creates Act, has been stalled for months as it faced opposition by the pharmaceutical industry. The bill has been placed on the Judiciary Committee calendar for Thursday, which would set it up for a vote next week.
Previous bipartisan measures on drug prices have struggled to get off the ground. The bill goes after a practice by brand-name drugmakers to block generic companies from making cheaper copies. Food and Drug Administration Commissioner Scott Gottlieb has accused drugmakers of “gaming” the system through the process, and his agency has aimed to clarify rules to rein in the practice.
To make cheaper medicines, generic drugmakers need thousands of copies of the brand-name product to run tests against their own version to gain FDA approval. Certain brand-name drugmakers, however, deny the request for the samples, pointing to safety programs that are designed to protect consumers.
The programs, which specify how drugs can be distributed, are known as the FDA’s Risk Evaluation and Mitigation Strategy, or REMS. They are required by government regulators for drugs that can be dangerous.
The bill would make it easier for manufacturers of generics to sue in those cases. Critics have said that the bill would mostly help lawyers, not consumers.
House members are looking for a compromise on legislation, House Speaker Paul Ryan, R-Wis., announced recently, but no timeline has been provided.
