Public Citizen Archives - Medical Design Sourcing

HHS OIG will review FDA’s approval of Biogen’s aducanumab

The HHS Office of Inspector General will review FDA’s accelerated approval pathway following the controversy surrounding the agency’s approval of the Alzheimer’s drug Aduhelm (aducanumab) from Biogen (NSDQ:BIIB) and Eisai (TYO:4523).

Among the controversies surrounding the drug’s approval is the use of the accelerated approval pathway, which led the agency to use a surrogate endpoint to approve aducanumab conditionally.

The HHS watchdog will investigate how the agency implements the accelerated pathway and will review “interactions between the FDA and outside parties as well as other aspects of the process, such as deciding on this pathway and scientific disputes,” HHS OIG said in a statement. In addition, the OIG will study FDA policies and procedures and the agency’s compliance with them. It will later make “appropriate findings and recommendations based on a sample of drugs approved using the accelerated approval pathway, which will include Aduhelm.”

Why FDA’s approval of aducanumab was unprecedented

The backlash surrounding aducanumab post-approval has put Biogen (NSDQ:BIIB) on the defensive, prompting the company’s head of research and development, Dr. Alfred Sandrock, to post an open letter to the Alzheimer’s disease community on Biogen’s website. In the letter, Sandrock lamented that there was “extensive misinformation and misunderstanding” regarding the drug.

In recent weeks, the company also requested that the FDA narrow the indication for the drug to focus on Alzheimer’s patients with mild cognitive impairment or mild dementia. The FDA had initially indicated it for all Alzheimer’s patients even though clinical trials focused on patients with milder forms of the disease.

The collaboration between FDA staff and Biogen

FDA closely worked with Biogen during the approval process of aducanumab. Critics such as Public Citizen have called the cooperation between the two organizations “unprecedented” and “inappropriately close.”

FDA had viewed data fr…

Cleveland Clinic, Mount Sinai decide to not use aducanumab for the foreseeable future

The drama surrounding the Alzheimer’s drug Aduhelm (aducanumab) from Biogen (NSDQ:BIIB) continues with the Cleveland Clinic and Mount Sinai refusing to use it until more data are available.

The company’s stock dropped 6.79% to $328.16.

After FDA decided to conditionally approve the drug for Alzheimer’s disease, three members of an FDA advisory committee have resigned, and politicians and advocacy groups such as Public Citizen have asked for the resignations of senior FDA officials. FDA recently agreed to narrow the indication for the drug to focus on patients with milder forms of the disease. FDA itself has called for an independent review of its dealings with Biogen leading up to its approval of the drug. Some internal staff members at FDA have also expressed reservations about the approval, according to The Wall Street Journal.

The Cleveland Clinic said its doctors can still prescribe aducanumab but that patients will need to receive the treatment a…

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…