FDA officials should resign over 'reckless' approval of Biogen Alzheimer’s drug, says US consumer rights group

A US consumer rights group has said the acting commissioner of the Food and Drug Administration (FDA) Janet Woodcock and other officials should “immediately resign” over the regulator’s approval of Biogen Inc’s (NASDAQ:BIIB) controversial Alzheimer’s drug, aducanumab.

In an open letter on Wednesday, Public Citizen, a Washington DC-based special interest group and think tank founded by former presidential candidate Ralph Nader, described the FDA’s approval of aducanumab last week as “reckless”, highlighting the “nearly unanimous conclusion of an independent advisory panel of experts that there was insufficient evidence that the drug was effective”.

READ: Biogen’s hefty price tag for new drug forecast to spark Alzheimer’s research resurgence

The group also pointed to what it said was an “inappropriate and unprecedented collaboration between the agency and Biogen during the data analysis stage of key clinical trials”.

Biogen had stopped a phase III trial of the drug in March 2019 on a recommendation it would not meet its final endpoint, only to start it again in October after reviewing the data further. The FDA’s decision to go against the recommendation of the advisory panel was also unusual, however, upon granting approval the regulator said it wanted more trial work done through confirmatory studies, although the company has nine years to complete these.

“Public Citizen contends that the FDA should have rejected the drug and required that the company conduct another large, placebo-controlled clinical trial before giving any further consideration to approving aducanumab to treat Alzheimer’s disease. Approving aducanumab despite the lack of evidence of effectiveness has raised false hope for millions of Alzheimer’s disease patients”, the organisation said.

The letter also derided Biogen’s pricing of the drug at US$56,000 per year, which analysts at Credit Suisse previously said was much higher than expected, as an “exorbitant” cost which “threatens to bankrupt the Medicare program”.

“The FDA’s decision to approve aducanumab for anyone with Alzheimer’s disease, regardless of severity, showed a stunning disregard for science, eviscerated the agency’s standards for approving new drugs, and ranks as one of the most irresponsible and egregious decisions in the history of the agency. The sheer recklessness of the FDA’s approval of aducanumab cannot be overstated. This decision is a disastrous blow to the agency’s credibility, public health and the financial sustainability of the Medicare program”, added Michael Carome, director of Public Citizen’s Health Research Group.

Biogen shares were up 0.8% at US$399 in mid-morning trading in New York.

Story by ProactiveInvestors