Janet Woodcock Archives - Medical Design Sourcing

FDA asks for an independent federal review of its aducanumab approval

Acting FDA Commissioner Dr. Janet Woodcock is responding to criticism about the agency’s controversial decision a month ago to approve aducanumab, Biogen’s and Eisai’s Alzheimer’s drug.

In a letter to Principal Deputy Inspector General Christi Grimm, Woodcock called for an independent investigation into the contacts between Biogen and FDA during the approval process. Biden has nominated Grimm to be inspector general. Grimm has served as the acting HHS inspector general since early 2020.

Woodcock stressed in the letter to Grimm that she has “tremendous confidence in the integrity of the staff and leadership of the Center for Drug Evaluation and Research involved in the aducanumab review and their commitment to unbiased and science-based decision-making.”

Yesterday, Biogen announced that the agency had limited its prescribing recommendations for the drug to a subset of Alzheimer’s patients. The agency had initially indicated it for all Alzheimer’s pa…

Public Citizen demands FDA resignations after aducanumab approval

The nonprofit watchdog group Public Citizen has sent a letter to HHS Secretary Xavier Becerra “to express its outrage” FDA’s recent approval of Biogen’s (NSDQ:BIIB) Alzheimer’s drug aducanumab (Aduhelm).

Public Citizen concluded that the safety and efficacy profile for the drug was unfavorable and asked that Becerra install an FDA commissioner who would consider withdrawing the Aduhelm approval. Public Citizen also called for the resignation or termination of three FDA officials: Acting FDA Commissioner Dr. Janet Woodcock, Center for Drug Evaluation and Research (CDER) Director Dr. Patrizia Cavazzoni and CDER’s Office of Neuroscience Director Dr. Billy Dunn.

Get the full story from our sister site, Drug Discovery & Development.

Public Citizen demands FDA resignations after aducanumab approval

The nonprofit watchdog group Public Citizen has sent a letter to HHS Secretary Xavier Becerra “to express its outrage” FDA’s recent approval of Biogen’s (NSDQ:BIIB) Alzheimer’s drug aducanumab (Aduhelm).

Public Citizen concluded that the safety and efficacy profile for the drug was unfavorable and asked that Becerra install an FDA commissioner who would consider withdrawing the Aduhelm approval. Public Citizen also called for the resignation or termination of three FDA officials: Acting FDA Commissioner Dr. Janet Woodcock, Center for Drug Evaluation and Research (CDER) Director Dr. Patrizia Cavazzoni and CDER’s Office of Neuroscience Director Dr. Billy Dunn.

The Alzheimer’s Association had backed the FDA approval, but many experts had concluded there was insufficient evidence to merit even conditional approval of the drug. Three members of an FDA advisory committee who had recommended against aducanumab’s approval recently resigned.

In its letter, Public…