“Unprecedented alliance”: House inquiry faults FDA, Biogen on rapid approval of Alzheimer's drug
The report lays out recommendations that the FDA should follow to “help restore the American people’s trust,” as well as measures that Biogen and other drug companies should take to “fulfill their responsibility to the patients and families.” Since the recommendations leave it to the FDA and company to change their policies, it is unclear whether they will actually prevent future episodes like this from occurring.
Aduhelm, a lab-made protein administered directly into a patient’s vein, was said to work by reducing a sticky substance in the brain called amyloid beta, which clumps between neurons and disrupts their function. Some scientists have theorized that buildup of amyloid beta in the brain causes Alzheimer’s disease.In September 2015, Biogen began enrolling patients in two Phase 3 clinical trials, which test the safety and effectiveness of a drug and compare it with standard treatment.
For example, the FDA issued accelerated approval for Aduhelm despite failing to gain the support of a single member of its own advisory committee, and without putting the idea up for discussion by any internal or external body. Although the report found that the company “appears to have developed financial assistance programs for eligible patients,” investigators wrote that “these programs would leave significant gaps in coverage.”
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