FDA calls for federal investigation into Alzheimer’s drug approval

The acting Food and Drug Administration commissioner on Friday called for a federal investigation into officials at his own agency who allegedly met with makers of an Alzheimer’s drug before its controversial FDA approval last month. .

Acting Commissioner Janet Woodcock has asked the Independent Office of the Inspector General to determine whether executives at Biogen, the company that makes Aduhelm, the drug in question, have met with FDA staff outside of official correspondence.

“Concerns continue to be raised… regarding contacts between Biogen and FDA officials during the review process, including some that may have taken place outside of the formal correspondence process,” Woodcock wrote in a letter published Friday to Acting Inspector General Christi Grimm.

“To the extent that these concerns could undermine public confidence in the FDA’s decision, I believe it is essential that the events in question be reviewed by an independent body such as the Office of Inspector General to determine if any interactions that occurred between Biogen and FDA review staff did not comply with FDA policies and procedures.

Given the constant interest and questions, I asked today that @OIGatHHS conduct an independent review and assessment of interactions between representatives of Biogen and the FDA during the process leading to Aduhelm’s approval. pic.twitter.com/iWJNxdZ5Cs

– Dr Janet Woodcock (@DrWoodcockFDA) July 9, 2021

Biogen shares fell more than 3% on the news.

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

The drug’s approval by the FDA on June 7 made it the first federally approved treatment for Alzheimer’s disease in about 18 years, but the decision was not without controversy.

The FDA’s own external advisers said in November that the data behind the drug was not strong enough – and even criticized FDA’s own staff for what they called an overly positive review.

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

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

The FDA’s go-ahead for the drug was crucial for Biogen, which struggles amid declining sales and loss of patent protection for one of its main drugs, Tecfidera, a sclerosis pill in plates.

“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 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.