Calls grow for an investigation into FDA approval of new Alzheimer’s drug
Calls grow for an investigation into Aduhelm’s approval
Former health secretary Donna Shalala called for a federal investigation into the FDA’s polarizing approval of Biogen’s Aduhelm, citing STAT’s reporting that regulators were far more closely aligned with the company than previously disclosed.
Speaking to STAT, Shalala said that “when you see a report like this, you have to investigate it. ... You've got to send in the Office of Inspector General.” Shalala joins a chorus of advocates and academics demanding answers on the close relationship between Billy Dunn, head of the FDA’s neuroscience division, and Biogen executives in the run-up to the approval of the drug, called Aduhelm. Public Citizen cited STAT’s reporting in a renewed call for an OIG investigation, as did Yale University public health professor Gregg Gonsalves.
But external pressure alone can’t force the OIG into action. The office sets its own agenda and sincerely values its independence, one former OIG attorney said.
Read more.
Calls grow for an investigation into Aduhelm’s approval
Former health secretary Donna Shalala called for a federal investigation into the FDA’s polarizing approval of Biogen’s Aduhelm, citing STAT’s reporting that regulators were far more closely aligned with the company than previously disclosed.
Speaking to STAT, Shalala said that “when you see a report like this, you have to investigate it. ... You've got to send in the Office of Inspector General.” Shalala joins a chorus of advocates and academics demanding answers on the close relationship between Billy Dunn, head of the FDA’s neuroscience division, and Biogen executives in the run-up to the approval of the drug, called Aduhelm. Public Citizen cited STAT’s reporting in a renewed call for an OIG investigation, as did Yale University public health professor Gregg Gonsalves.
But external pressure alone can’t force the OIG into action. The office sets its own agenda and sincerely values its independence, one former OIG attorney said.
Read more.