The Medicare programme restricted its coverage, which has led to severely limited use of the Biogen drug.
The agency should ensure that all substantive interactions with drug sponsors are properly memorialised, establish a protocol for joint briefing documents with drug sponsors, and update its industry guidance on the developments and review of new Alzheimer’s drugs, the report recommended. “As stated in the congressional report, an review concluded that, 'There is no evidence that these interactions with the sponsor in advance of filing were anything but appropriate in this situation,'” Biogen said.
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