The Food and Drug Administration’s acting commissioner on Friday required a federal investigation into officials inside her own agency who allegedly met with the makers of an Alzheimer’s drug in front of its dubious endorsement last month by the FDA.
Acting Commissioner Janet Woodcock approached the autonomous Office of the Inspector General to investigate whether executives from Biogen, the company that makes Aduhelm, the drug being referred to, met with FDA staff outside of formal correspondence.
“There keep on being concerns raised … in regards to contacts between delegates from Biogen and FDA during the audit interaction, including some that may have happened outside of the formal correspondence measure,” Woodcock wrote in a letter presented Friday on acting Inspector General Christi Grimm.
“To the degree these worries could subvert the public’s trust in FDA’s choice, I trust it is important that the occasions at issue be surveyed by an autonomous body, for example, the Office of Inspector General to decide if any collaborations that happened among Biogen and FDA audit staff were inconsistent with FDA policies and procedures.”
Shares of Biogen fell multiple percent on the news.
“We will, obviously, help out any request regarding a potential audit of the administrative interaction,” a Biogen representative said in a statement.
The FDA’s June 7 endorsement of the drug made it the main federally supported treatment for Alzheimer’s in around 18 years, yet the choice wasn’t without debate.
The FDA’s own external counselors in November said the information behind the drug wasn’t sufficient — and surprisingly criticized the FDA’s own staff for what it called an excessively certain survey.
In 2019, Biogen stopped preliminaries of the medicine after a free gathering said early information showed it was probably not going to work.
Months after the fact, the company declared it would look for administrative endorsement for the drug at any rate.
The FDA greenlight of the drug was vital for Biogen, which is battling in the midst of declining deals and the deficiency of patent insurance for one of its significant drugs, Tecfidera, a pill for various sclerosis.
“We are very much aware of the consideration encompassing this endorsement,” Dr. Patrizia Cavazzoni, head of the FDA’s Center for Drug Evaluation and Research, said last month after the agency endorsed the drug.
“We comprehend that Aduhelm has collected the consideration of the press, the Alzheimer’s patient local area, our elected officials, and other intrigued partners,” she proceeded.