Trickle Up Economics? The Case For Funding US Medicare Coverage Reviews
Former CMS Administrator (and ex FDA Commissioner) Mark McClellan argues that the Aduhelm experience shows why the Medicare agency needs a bump in appropriations.
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Former FDA principal deputy commissioner Amy Abernethy says cell and gene therapy is an area primed for improved ‘parallel conversation’ between FDA and CMS on data requirements.
FDA is trying one more time to secure significant resources to fund regulatory science. FDA's leadership is making good progress with key figures in the Administration and on the Hill-but the money still isn't there.
Why not wait for the confirmatory trial to read out before approval, at least in the context of an especially uncertain or controversial surrogate marker?