The FDA actively – and unusually – collaborated with a biopharmaceutical company to pursue the approval of an Alzheimer's Disease drug, despite many questions about its efficacy and astronomical price. A congressional investigation found that the FDA’s approval process was “rife with irregularities" and that the agency’s actions “raise serious concerns about FDA’s lapses in protocol.”
The FDA’s controversial approval of Aduhelm, the drug intended to treat Alzheimer’s Disease, has resulted in resignations from their advisory committee and now investigations, both internal and Congressional. The FDA and editors of JAMA Internal Medicine are speaking out before the investigational circus comes to town.
There has been a lot of ink spilled, and bytes spent this week discussing the FDA’s approval of aducanumab, brand-name Aduhelm, for the treatment of Alzheimer’s Disease. I have mixed feelings; there are advantages to a Phase 4 study, but how do you say no to hope?