When regulatory cooperation goes too far, we all lose

An image showing an Alzheimer's disease patient

Source: © Charles Krupa/AP/Shutterstock

Were FDA staff unduly influenced by Biogen in approving Alzheimer’s antibody?

Pharmaceutical regulators took more risks in 2021 than perhaps they normally might. Decisions around vaccines and antivirals for Covid-19 were definitely expedited, and that fact was distorted by anti-vaccine campaigners seeking to sow doubt. But the decisions were generally backed by solid evidence and independent scientific advice. The same cannot be said of the US Food and Drug Administration’s (FDA) approval of an antibody to treat Alzheimer’s disease in June.