#FDA calls for federal investigation into approval of Alzheimer’s drug

The Food and Drug Administration’s acting commissioner on Friday called for a federal investigation into officials within her own agency who reportedly met with the makers of an Alzheimer’s drug ahead of its controversial approval last month by the FDA.

Acting Commissioner Janet Woodcock called on the independent Office of the Inspector General to investigate whether executives from Biogen, the company that makes Aduhelm, the drug in question, met with FDA staff outside of formal correspondence.

“There continue to be concerns raised … regarding contacts between representatives from Biogen and FDA during the review process, including some that may have occurred outside of the formal correspondence process,” Woodcock wrote in a letter posted Friday to acting Inspector General Christi Grimm.

“To the extent these concerns could undermine the public’s confidence in FDA’s decision, I believe it is critical that the events at issue be reviewed by an independent body such as the Office of Inspector General in order to determine whether any interactions that occurred between Biogen and FDA review staff were inconsistent with FDA policies and procedures.”

Shares of Biogen fell more than 3 percent on the news.

“We will, of course, cooperate with any inquiry in connection with a possible review of the regulatory process,” a Biogen spokesperson said in a statement.

The FDA’s June 7 approval of the drug made it the first federally approved treatment for Alzheimer’s in about 18 years, but the decision wasn’t without controversy.

The FDA’s own outside advisers in November said the data behind the drug wasn’t strong enough — and even criticized the FDA’s own staff for what it called an overly positive review.

In 2019, Biogen halted trials of the medication after an independent group said early data showed it was unlikely to work. 

Months later, the company announced it would seek regulatory approval for the drug anyway.

The FDA greenlight of the drug was crucial for Biogen, which is struggling amid declining sales and the loss of patent protection for one of its major 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 last month after the agency approved the drug.

“We understand that Aduhelm has garnered 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 get the drug on the market.