Aduhelm Approval Raises Concerns About US FDA Leadership, Senate Finance Chair Suggests
Ron Wyden points to expectations Biogen’s drug will impose a heavy cost burden on Medicare as he questions FDA’s decision to approve aducanumab. He also expresses interest in a government-sponsored technology assessment program that could help establish the value of drugs.
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Janet Woodcock has been a no-nonsense acting commissioner, but there’s plenty of drama in the nomination process as opposition and support for her to become permanent head of the US FDA continues to mount while the wait for President Biden’s nominee drags on.
The butterfly effect is an elegant analogy to describe the seemingly unpredictable and far-reaching implications of a relatively small and inconsequential event. The FDA’s approval of Aduhelm is not so much a butterfly gently flapping its wings, but rather a sonic boom emanating from a jet engine. Most immediately, it provides a new therapeutic option for millions of patients in dire need of hope, vindicating Biogen’s faith with a revenue stream running into many billions of dollars. Longer-term the reverberations may be felt across the entire industry, throwing into question the evidentiary requirement for drug development.
Some Democratic senators are not fans of FDA’s approval of Biogen/Eisai’s Aduhelm, and are even more critical of the price of the Alzheimer’s therapy. That is providing a new hook to urge action on creating a federal price ‘negotiation’ program – but not any more clarity on a viable path to enacting one.