Senate bill would save money and allow generics to reach market more quickly, according to CBO report
pharmafile | September 20, 2018 | News story | Business Services, Medical Communications, Sales and Marketing | CBO, Senate, US, biosimilars, generics, law, politics
The Congressional Budget Office (CBO) has said in a report that a bipartisan bill awaiting a vote in the senate would allow generic versions of drugs to reach the market more quickly and reduce federal spending on prescription drugs, in the United States.
The report states that: “CBO expects that the bill’s provisions would allow generic drugs (including biosimilar versions of biologics) to enter the market earlier, on average, than they would under current law. Because of the earlier entry of lower-priced generic drugs, CBO estimates, enacting the legislation would reduce federal spending on prescription drugs.”
The legislation, known as the CREATES Act would prevent brand name drugmakers from denying drug producers the samples that are needed in order to run tests as part of the process of gaining FDA approval.
The CBO report states that “S. 974 would create a private right of action that allows developers of generic drugs or biosimilar products to bring civil lawsuits against manufacturers of brand-name drugs if sufficient quantities of reference samples of a branded product are not made available for premarket testing. (To obtain marketing approval of their products from the Food and Drug Administration (FDA), developers of generic or biosimilar drugs currently must purchase reference samples to conduct the testing required to demonstrate that their drugs meet the FDA’s approval criteria.)”
While the CREATES Act passed the Senate judiciary committee in June, the ruling has not yet been scheduled for a vote on the floor.
In reference to the Judiciary committee’s decision however, the American Hospitals Association (AHA) commented: “The Senate Judiciary Committee today voted 16-5 to approve the Creating and Restoring Equal Access to Equivalent Samples Act (S. 974). The AHA-supported bill would allow generic drug manufacturers facing certain anticompetitive delay tactics to bring an action in federal court for injunctive relief. More than 45 organizations, including the AHA, last week urged the committee to support the legislation to “end the anticompetitive abuses utilized by some brand-name manufacturers, help restore the balance between innovation and affordability that Congress intended, and achieve the goal of more affordable prescription drugs.” The Congressional Budget Office estimates the legislation will save $3.8 billion over 10 years.”
Louis Goss
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