The Food and Drug Administration (FDA)’s approval of Biogen’s Aduhelm was based on shaky data. The resulting controversy continues to build and shed light on the FDA’s approval processes, such as its use of expert panels.
“Never mind the conflicts, there are drugs to approve. In a sorry turn of events, the Food and Drug Administration is facing a confidence-draining debacle thanks to its controversial approval of a pricey Alzheimer’s drug for which evidence appears suspect, at best.” Read more here.
(Source: Ed Silverman, STAT News, 7/19/21)