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Replies to post #228548 on DD Support Board and Research Team
In the summer of 2021, the US Food and Drug Administration (FDA) caused a stir when they approved the drug Aduhelm for early Alzheimer’s Disease, over the objections of their advisory group. Experts worried that Aduhelm’s lack of proven effectiveness and ridiculously high price set a dangerous precedent for future drug approvals. The approval was so controversial that the Centers for Medicare and Medicaid Services (CMS) declined to cover the cost of the drug for Medicare patients outside of clinical trials.
Now, a recent congressional investigation found that the FDA and Aduhelm’s manufacturer Biogen collaborated in atypical and often inappropriate ways during the development process to assure the drug’s approval. For example, FDA staff had 66 calls with Biogen that were not documented (which is against agency protocol); FDA staff worked closely with Biogen on a briefing document for an agency committee and gave Biogen material to add to their presentation; and the FDA approved the drug for anyone with Alzheimer’s Disease despite the drug only being tested on those with mild cognitive impairment, and Biogen being aware of the lack of evidence for effectiveness and safety in this population.
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