WASHINGTON, D.C. — Secretary of Health and Human Services Xavier Becerra should ask the department’s Office of Inspector General (OIG) to immediately investigate the unprecedented and inappropriate close collaboration between the U.S. Food and Drug Administration (FDA) and Biogen regarding the company’s application for approval of the Alzheimer’s disease drug aducanumab, Public Citizen said today in a letter to Becerra.
“Given the gravity of our concerns, more definitive, prompter actions by the OIG and HHS must be taken,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group and author of the letter. “The prior close collaboration between the FDA and Biogen dangerously compromised the integrity of the FDA’s review.”
Public Citizen warned Becerra of the adverse consequences if the FDA were to approve aducanumab despite the lack of evidence of effectiveness. In addition to providing false hope to millions of Alzheimer’s disease patients and their families, approval of the drug now would pose an unacceptable threat to the financial health of the Medicare program.
“At a projected price of about $50,000 for one year of aducanumab treatment and with an estimated market of 10 million patients in the U.S. according to Biogen’s CEO, annual expenditures for the drug could reach $50 billion if just one in ten of these Alzheimer’s disease patients were prescribed aducanumab,” said Carome. “Whatever the exact amounts, the economic costs to the Medicare program would be extraordinary and only justifiable for a drug that has definitive evidence of significant, clinically meaningful benefit.”
On Dec. 9, 2020, Public Citizen called on the OIG to launch an investigation of the FDA-Biogen collaboration, but the office replied with a short, pro forma letter signaling that it did not intend to pursue such action.
The letter also urged Becerra to direct the FDA to temporarily remove the head of the office that collaborated with Biogen pending the completion of the requested OIG investigation and reassign all further review and decision-making regarding aducanumab to staff not involved in the collaboration with Biogen. Public Citizen further stressed that it is imperative the FDA not approve aducanumab given the clear lack of evidence that the drug is effective for treating Alzheimer’s disease.