Art WalaszekUpdate on #aducanumab fiasco:
Congressional investigation into regulatory capture of the FDA is damning:
FDA's approval process was "rife with irregularities"
The investigation found that:
1. FDA's interactions with Biogen (manufacturer of aducanumab) were atypical & failed to follow the agency's own documentation protocol
2. FDA & Biogen inappropriately collaborated on a joint briefing document for the Peripheral & Central Nervous System Advisory Cmte that did not adequately represent differing views within FDA
3. FDA pivoted to using the accelerated approval pathway for aducanumab on a substantially abbreviated timeline
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4. FDA approved & Biogen accepted a broad label indication for aducanumab (initially, "Alzheimer's disease") even though Biogen's studies included only people with MCI or very early dementia - and despite Biogen's reservations!
5. Biogen set an unjustifiably high price ($56k per year initially, then the still too high $28k/yr) for aducanumab to "make history" for the company - despite the devastating impact this would have on Medicare
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6. Biogen expected aducanumab to be a burden to Medicare and costly to patients - they projected it would cost Medicare $12b per year, i.e., 36% of the Part B budget (!) and some Medicare patients could face out-of-pocket costs of up to 20% of their income (!!)
7. Biogen planned to spend 2.5x on marketing ($3.3 billion in 4 years) than it had spent on R&D (over 14 years)