This week, Congressional investigators released a report on the FDA's accelerated approval of Alzheimer's drug Aduhelm. The report found that the agency's review and approval process had deviated from the FDA's guidance and procedures, as well as criticized the drug's high price, which has impeded patient access.
Aduhelm is the first FDA-approved drug for Alzheimer's since 2003 and targets amyloid beta plaque which is thought to play a role in Alzheimer's. The drug's launch has been controversial due to the FDA sidestepping expert outside advisers who said clinical trials failed to prove effectiveness of the drug.
The report also found that the cost of Aduhelm was "unjustifiably high" and that Biogen was aware that the high price would be a burden on Medicare and costly to patients, with some estimates showing out-of-pocket costs up to 20 percent of income. In response, the FDA has said it is already starting to implement changes recommended by the committees and that drug sponsors need to consider patient access when setting prices.
The findings of the report have raised important questions around protocols, transparency, public trust and patient access when it comes to drug approvals. The FDA and drug sponsors must take steps to ensure these issues are addressed in future drug approvals. The agency is expected to release a decision on another Alzheimer's drug lecanemab, developed by Biogen and Eisai, next week.