Accelerated Approval: How The Aduhelm Probes Will, And Won’t, Impact The Debate
Even as the US FDA can expect to be put through the ringer with the congressional and HHS Inspector General probes, the process could have some upsides for the agency, according to former officials who have been through such scrutiny.
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US FDA’s oncology chief says he won’t talk to sponsors unilaterally when a company takes issue with their review division. Pazdur also weighed in on his long-term career plans and his views on the FDA-industry revolving door at two ASCO interviews.
Biogen is making clear that its decision to cut the price of the Alzheimer’s therapy Aduhelm is in no way tied to the upcoming US Medicare coverage decision for the treatment. But it still shows how Medicare can already ‘negotiate’ prices even without explicit statutory authority.
HHS Inspector General’s timeline means Congress won’t have findings to use during upcoming user fee renewal debate; ‘review’ is not an ‘investigation’ which could come with potentially more damning legal consequences for the agency.