FDA’s Mismanaged Aduhelm Review: What Went Wrong
Two House committees have launched investigations into the US FDA approval of Biogen/Eisai’s Aduhelm for Alzheimer’s, assuring that headlines questioning the effectiveness of the therapy will continue. It didn’t have to be this way.
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Scott Gottlieb says that some meetings should remain in-person, but with virtual options proven effective, the FDA could offer more opportunities to talk to sponsors.
Accelerated Approval Makes Big Splash In 2021 Novel Agents, Despite Crackdown On ‘Dangling’ Cancer Claims
US FDA’s accelerated approvals hit a contemporary high in 2021, accounting for one-third of novel US approvals, but the big story was the agency’s crackdown on delinquent confirmatory trials for oncology AA indications.
Plenty of people believe the US FDA should never have approved Biogen/Eisai’s Alzheimer’s therapy. But does that really mean it is okay for the Medicare agency to decide as a matter of policy that the drug has not been proven safe and effective?