America’s science policies are changing. America’s scientists need to change with them. The recent controversies over the Food and Drug Administration’s accelerated approval of an Alzheimer’s treatment are a lesson in the costs of failing to do so.
A year ago, the FDA fast-tracked Biogen’s aducanumab — the first new Alzheimer’s drug in almost 20 years — even after an expert panel nearly unanimously recommended against giving it the green light. The decision has been so contested that lawmakers are now trying to change the FDA’s accelerated approval process.
Besides fueling controversy, the approval is a rare reveal into the hidden workings of America’s scientists — and how those workings can be flawed.
