A US congressional report released this week noted that the Food and Drug Administration (FDA) failed to heed its own advice when approving Aduhelm, a controversial treatment for Alzheimer’s disease. The report blamed the agency for overlooking key issues with data surrounding the drug’s actual clinical efficacy. In addition, it lambasted Biogen, the drug’s manufacturer, for the exorbitant price tag.
Commissioner Rob Califf discussed the US Food and Drug Administration’s (FDA) approach to the opioid crisis and how the agency will pivot in the near future. In the blog post, he noted that the FDA needs to reevaluate the metrics it uses to study safe usage guidelines for opioids. The agency will pursue this goal with its new Overdose Prevention Framework, which seeks to reduce overdoses with a multi-pronged approach.