Food and Drug Administration (FDA) drew criticisms after granting Alzheimer’s disease drug Aduhelm a conditional approval. It allows the drug scientifically known as aducanumab to be prescribed and used while its maker Biogen conducts a post-marketing, phase 4 confirmatory study that could take years to complete. Aduhelm is the first Alzheimer’s medication approved by the FDA since 2003. According to the influential Institute for Clinical and Economic Review (ICER), the FDA “has failed in its responsibility to protect patients and families from unproven treatments with known harms” in approving Aduhelm. ICER questions Aduhelm’s effectiveness The FDA, which announced the approval on June 7, said that the drug was the first to treat the underlying mechanism in Alzheimer’s. But ICER didn’t see it that way.