Former FDA adviser calls for further investigation into Alzheimer’s drug
pharmafile | July 21, 2021 | News story | Research and Development |
A former FDA advisor who resigned after the controversial approval of Biogen’s Alzheimer’s drug has called for a wider probe into how the drug was given the green light.
Earlier this month acting FDA Commissioner Janet Woodcock asked the Office of the Inspector General at the Department of Health and Human Services to investigate whether FDA representatives’ interactions with Biogen were inconsistent with agency policies.
However, Dr Aaron Kesselheim of Harvard-affiliated Brigham and Women’s Hospital, who resigned as a member of the FDA advisory panel that reviewed and voted against approval of Aduhelm, said: “I happen to think that there’s a lot more to investigate than just that.”
As reported in Reuters, Dr Kesselheim said more information is needed on FDA’s role in Biogen’s evaluation of clinical trial data, as well as why the agency decided to base its approval on a “surrogate” biomarker rather than the drug’s impact on cognitive function.
He said: “If the FDA knows about some really clear scientific evidence … they should share that because I don’t think there is a lot of clarity around that in the field right now.”
Dr Kesselheim was one of three panel members who resigned after the drug’s approval, not one of the panel members voted in favour of the drug, and most experts are doubtful that the drug works at all.
It also comes at a high annual price of $56,000 dollars. Biogen recently amended their guidance on who should take the drug.