FDA chief asks for independent investigation into approval of Biogen's Alzheimer's drug Aduhelm
The FDA’s reportedly cozy relationship with Biogen ahead of its controversial approval of the drugmaker’s Alzheimer’s disease therapy, Aduhelm, has been at the center of calls for an investigation. And now, even the agency’s own chief has joined in.
The FDA’s interim commissioner, Dr. Janet Woodcock, in a letter dated Friday requested the Office of the Inspector General to conduct an independent investigation into the regulator’s decision to approve Biogen’s Aduhelm, which has roiled lawmakers, physicians and others for weeks.
Woodcock noted that there “continues to be concerns raised” regarding the contact between FDA officials and Biogen ahead of the agency’s decision, “including some that may have occurred outside of the formal correspondence process.”
Woodcock’s request follows an explosive report from Stat News that found Biogen executives met with FDA officials, specifically Billy Dunn, M.D., director of the FDA’s neuroscience unit, as early as 2019 to discuss a regulatory pathway for Aduhelm. Those meets occurred even when it seemed like the drug was dead in the water.
The FDA’s reportedly cozy relationship with Biogen ahead of its controversial approval of the drugmaker’s Alzheimer’s disease therapy, Aduhelm, has been at the center of calls for an investigation. And now, even the agency’s own chief has joined in.
The FDA’s interim commissioner, Dr. Janet Woodcock, in a letter dated Friday requested the Office of the Inspector General to conduct an independent investigation into the regulator’s decision to approve Biogen’s Aduhelm, which has roiled lawmakers, physicians and others for weeks.
Woodcock noted that there “continues to be concerns raised” regarding the contact between FDA officials and Biogen ahead of the agency’s decision, “including some that may have occurred outside of the formal correspondence process.”
Woodcock’s request follows an explosive report from Stat News that found Biogen executives met with FDA officials, specifically Billy Dunn, M.D., director of the FDA’s neuroscience unit, as early as 2019 to discuss a regulatory pathway for Aduhelm. Those meets occurred even when it seemed like the drug was dead in the water.