Drug Pricing Debate Will Carry Over To 2020
An eventful year for sweeping drug pricing legislative proposals in the US will end with enactment of a long-standing carryover proposal – new procedures intended to address perceived abuses of the REMS process – but nothing more substantial for the drug industry.
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Bill addresses ‘dead zone’ for pending applications for protein products transitioning to biologic status; generic and brand industries each win in different legislative provisions: inclusion of the CREATES Act, and a revised definition for ‘biologics’ that includes chemically synthesized polypeptides.
Broad bipartisan support and billions in projected savings mean that bill may finally pass. But whether it will work as intended to improve generic access to market remains as questionable as ever.