WASHINGTON, D.C. – Following the stunning new disclosures in a detailed exposé published yesterday by STAT about how Biogen used a U.S. Food and Drug Administration (FDA) back channel to win approval for aducanumab, Public Citizen in a letter to U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra today again called for top FDA officials responsible for the reckless approval of aducanumab for Alzheimer’s disease, including Acting Commissioner Janet Woodcock, to immediately resign or be removed.
In a separate letter, Public Citizen also again urged the HHS Office Inspector General (OIG) the office to investigate the unprecedented and inappropriately close collaboration between the FDA and Biogen before and after the submission of the company’s application for approval of aducanumab, including the troubling circumstances detailed in the STAT article.
“The circumstances described in the STAT exposé, if confirmed, paint a damning picture of drug regulators who surrendered their independence and objectivity, essentially began working on behalf of Biogen, and fostered regulatory capture at the agency,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group and author of the letter.
On June 7, the FDA announced its approval of aducanumab for treatment of Alzheimer’s disease despite the nearly unanimous conclusion of an independent advisory panel of experts that there was insufficient evidence that the drug was effective. On June 16, Public Citizen first called on Secretary Becerra to seek the resignations or removal of Woodcock and other senior FDA officials responsible for the reckless approval of aducanumab.
Among the many troubling revelations described in the STAT exposé was an ‘off-the-books’ May 2019 meeting between Dr. Billy Dunn, the director of the FDA office responsible for the review of Alzheimer’s disease drugs, and Biogen Chief Scientist, Al Sandrock. At this meeting, which followed Biogen’s announcement two month earlier to discontinue development of the drug because clinical trials appeared to show the drug did not work, Sandrock, according to STAT, wanted to know if Dunn would be open to helping find a way to get the drug approved.
A former Biogen employee told STAT that “It was clear that Billy Dunn was an ally, so the job for Biogen became figuring out how to support his efforts within the FDA.”
“FDA’s decision to approve aducanumab is a disastrous blow to the agency’s credibility, public health and the financial stability of the Medicare program,” said Carome. “It is imperative that that HHS OIG and Congress thoroughly investigate this decision and the circumstances that preceded it, including the inappropriately close collaboration between the FDA and Biogen that corrupted FDA’s review and decision-making process for the drug.”