The Food and Drug Administration’s acting commissioner on Friday called for a federal investigation into officials from his own agency who reportedly met the makers of the Alzheimer’s drug ahead of its controversial approval by the FDA last month.
Acting Commissioner Janet Woodcock called the independent office of the inspector general to investigate whether officials from Biogen, which owns EduHelm, the drug maker, met with FDA employees outside of formal correspondence.
“With regard to contacts between representatives of Biogen and the FDA during the review process, there are some that may occur outside of the formal correspondence process,” Woodcock wrote in a letter posted Friday to Acting Inspector General Christie Grimm.
“To the extent these concerns may undermine the public’s confidence in the FDA’s decision, I believe it is important that the incidence of the issue is reviewed by an independent body such as the Office of the Inspector General to determine to determine whether there has been an interaction between Biogen and the FDA. The FDA review staff was inconsistent with FDA policies and procedures.”
Biogen shares fell more than 3 percent on the news.
“Certainly, we will cooperate with any investigation regarding a possible review of the regulatory process,” a Biogen spokesperson said in a statement.
The FDA’s approval of the drug on June 7 made it the first federally approved treatment for Alzheimer’s in nearly 18 years, but the decision was not without controversy.
In November the FDA’s own external advisers said the data behind the drug was not strong enough — and even criticized the FDA’s own staff for what it called an overwhelmingly positive review.
In 2019, an independent group said Biogen halted trials of the drug after early data showed it was unlikely to work.
Months later, the company announced that it would seek regulatory approval for the drug anyway.
The drug’s FDA greenlight was critical of Biogen, which is struggling amid declining sales and the loss of patent protection for one of its flagship drugs, Tecfidera, a pill for multiple sclerosis.
“We are well aware of the attention surrounding this approval,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said after the agency approved the drug last month.
“We understand that Aduhelm has attracted the attention of the press, the Alzheimer’s patient community, our elected officials and other interested stakeholders,” she continued.
The renewed call for an investigation from the top of the FDA comes after STAT News reported that FDA officials worked hand in hand with Biogen executives to bring the drug to market.