This article was originally published in RPM Report
Summary of major stories in February issue
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COVID treatments have not advanced as rapidly or as publicly as vaccines. That may trigger some issues for the US FDA as Congress digs into the next phase of the COVID response – and starts to assess agency performance and leadership after the crisis.
Trump Administration’s attempt to eliminate rebates in the US Medicare outpatient drug benefit program is the easiest and most certain item among the 11th hour pricing policy changes for the incoming Biden Administration to undo. But it still had a major impact on the dynamics of the drug pricing debate.
Multiple simultaneous sponsors, foreshortened regulatory reviews, and a packet of unanswered post-approval efficacy issues make for what should be very competitive – and inherently comparative – post-market assessment period for the upcoming SARS-CoV-2 vaccines.