Lower-price drugs would hit the market faster under a bipartisan bill awaiting a vote in the Senate, according to a score released Wednesday by the Congressional Budget Office and the Joint Committee on Taxation.
“CBO expects that the bill’s provisions would allow generic drugs … to enter the market earlier, on average, than they would under current law,” authors of the report concluded.
The legislation, known as the CREATES Act, passed the Senate Judiciary Committee in June but hasn’t yet been scheduled for a vote on the floor. CBO estimates that it would reduce spending by $3.3 billion from 2019 to 2028, mostly through the Medicare and Medicaid programs spending less on prescription drugs.
The bill goes after a practice brand-name drugmakers use 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.
When generic drugs are delayed from getting to market, brand-name companies can continue selling drugs at a higher price.
The bill would make it easier for manufacturers of generics to sue when brand manufacturers don’t turn over samples. Critics have said that the bill would mostly help lawyers, not consumers.
