Updated: FDA pulls paid Eisai consultant from temporary role on adcomm reviewing Eisai's new Alzheimer's drug
The FDA’s advisory committees of outside experts are supposed to offer the agency with unbiased reviews of the sponsor’s efficacy and safety data before them. And while occasionally the FDA will allow certain tangentially paid consultants (e.g. from a competing firm), those relationships must be disclosed ahead of time, and waivers from that COI need to be granted.
In the case of David Weisman, a neurologist with Pennsylvania-based Abington Neurological Associates who worked on clinical trials for Eisai and Biogen, the FDA had sought his expertise in Friday’s adcomm that will discuss whether to convert Eisai’s new Alzheimer’s drug Leqembi (lecanemab) into a full approval. The decision is likely to be one in favor of Leqembi, opening the door for wider sales nationwide with CMS coverage.
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