In June, the FDA approved Biogen’s drug (now marketed as Aduhelm) by using an “accelerated” approval process similar to the consideration it gave COVID-19 vaccines that received emergency use authorization last year.
The FDA said it uses the expedited approval process for treatments of a serious or life-threatening illness if the treatment in question is expected to be better than the options currently available to patients.
The agency cited trials showing that the drug reduced amyloid plaque, which builds up in the brain and is believed to play a key role in causing Alzheimer’s disease. However, trials of the drug were paused in 2019 because they failed to show promising results. The following year, the FDA called together an expert panel to review the trial evidence of Adhulem. None of the experts involved recommended approving the drug, although one expert voted uncertain.
Approval sparks debate
The agency's speedy approval of the antibody-based drug gave way to controversy. Three members of the FDA’s advisory panel resigned in protest, and at least one member questioned whether there is enough evidence to show that the drug is effective at treating Alzheimer’s disease.
Now, Porter wants officials to investigate the relationship between Biogen and the FDA. In the letter, Porter said it appears “very clear” that the drug maker “had an inside route to FDA officials and had undue influence over their decision making and the evidence presented in various settings.”
“Patients should have confidence that their treatment plans are based on science, not cozy relationships between Big Pharma and FDA officials,” Porter said in a tweet.
Porter is calling for “a full review” of the FDA’s communications with pharma executives, lobbyists, and other stakeholders. She is also calling on the agency to establish new policies that prevent “fraud, waste, and abuse.”
Backlash regarding approval and pricing
Other lawmakers have also challenged the approval of the Alzheimer’s drug. In a letter to the Senate Finance Committee late last month, Sens. Elizabeth Warren (D-Mass.) and Bill Cassidy (R-LA) called for a hearing to “examine the vexing new questions and challenges” that Aduhelm presents to the Medicare program.
Separately, Sen. Joe Manchin (D-WV) urged President Biden in a letter last month to remove interim commissioner Dr. Janet Woodcock. He cited the FDA’s Aduhelm approval as his reasoning.
Biogen’s decision to set the drug’s list price at $56,000 per year has also been controversial, but the drugmaker said recently that the estimated price is subject to change. The company said it won’t have to charge as much for the drug if demand turns out to be high.