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A Senate bill that would give generic companies a pathway for suing brand-name rivals when denied access to needed samples would lower federal government spending by $3.3 billion on medicines, according to a new analysis.

Known as the CREATES Act, the legislation would also yield about $600 million in revenue through lower premiums in federal health plans, generating a combined impact of $3.9 billion on the federal budget from 2019 through 2028, according to the report from the Congressional Budget Office. The bill is expected to accelerate entry of affected lower-cost generic or biosimilar medicines by one to two years.

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  • If failing memory serves, the very first REMS was to allow Celgene to put thalidomide (that accursed drug product) into the American pharma market safely. Now … it is viewed rather differently. That flexible regulatory solution is now being used to castigate Celgene, as mentioned above.
    I wonder if that nugget will come up in the already toxic NJ US senate race?

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