Two congressional committees recently released damning results of an 18-month investigation into the Food and Drug Administration’s approval of Biogen’s controversial Alzheimer’s drug, Aduhelm. The systems that enabled Biogen’s actions, however, went largely unscrutinized.
The report listed extensive and serious concerns about Aduhelm’s rollout, including “atypical” interactions and collaboration between the FDA and Biogen; inappropriate use of the FDA’s Accelerated Approval Program; initially approving the product for anyone with Alzheimer’s despite only testing it on patients in early and mild stages of the disease; and the company setting an “unjustifiably high price” for the drug. The report also noted that Biogen planned to spend billions of dollars on sales marketing for Aduhelm — more than twice its development costs for the product — with a specific strategy of targeting communities of color.
With each new story about problems in the pharmaceutical industry comes a chorus of complaints and calls for it to do better. The congressional report itself made its fifth and final recommendation that Biogen and other drug sponsors “should consider value and patient access when setting prices.”
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