FDA Head Asks for Investigation Into Connection Between Aduhelm Maker, Drug Reviewers

The acting head for the Food and Drug Administration (FDA) asked Friday for the government to investigate connections between drug reviewers and the manufacturer of a controversial new Alzheimer's drug, the Associated Press reported. The costly drug, Aduhelm, was approved in June despite recommendations from the agency's outside experts.

Dr. Janet Woodcock said on Twitter she had requested that the Department of Health and Human Services, which supervises the FDA, look into the circumstances of the drug's approval. Two congressional committees have already initiated their own probe into the green-lighting of Aduhelm, whose effectiveness is unproven, the AP said.

"We believe an independent assessment is the best manner in which to determine whether any interactions that occurred between the manufacturer and the agency's review staff were inconsistent with FDA's policies and procedures," Woodcock said. Twitter.

"The trust of the American public, especially during these difficult times, is of the utmost importance to the FDA — and we will continue to exercise transparency around our decision-making as allowed by the law," she wrote in another tweet.

For more reporting from the Associated Press, see below:

Dr. Janet Woodcock
Janet Woodcock, acting head of the FDA, has called for an investigation into contacts between drug reviewers and the maker of a controversial new Alzheimer's drug, Aduhelm. Above, Woodcock and former U.S. Representative Jim Greenwood speak at the Klick Health Ideas Exchange on June 15, 2015, in Philadelphia. Neilson Barnard/Getty Images

Last month, health news site Stat reported several new revelations about the unusually close collaboration between Aduhelm drugmaker Biogen and FDA's drug review staff. In particular, the site reported an undocumented meeting in May 2019 between a top Biogen executive and the FDA's lead reviewer for Alzheimer's drugs.

The meeting came after Biogen stopped two studies because the drug seemed didn't seem to slow the disease as intended. Biogen and the FDA began reanalyzing the data together, concluding the drug may actually work. The collaboration ultimately led to the drug's conditional approval two years later, on the basis that the drug reduced a buildup of sticky plaque in the brain that is thought to play a role in Alzheimer's disease.

FDA interactions with drug industry staff are strictly controlled and almost always carefully documented. It's unclear if the May 2019 meeting violated agency rules.

The FDA has faced an intense public backlash since approving the drug, which costs $56,000 a year and requires monthly IVs. On Thursday, the agency took the unusual step of vastly scaling back prescribing information on the drug. The agency and Biogen announced the new label would recommend it only be given to patients with mild or early-stage Alzheimer's. That came after many doctors criticized the original label as too broad, stating only that it could be used in anyone with Alzheimer's.

Aduhelm hasn't been shown to reverse or significantly slow the disease. But the FDA said that its ability to reduce clumps of plaque in the brain is likely to slow dementia. Biogen is required to conduct a follow-up study to definitively answer whether it really works. Other Alzheimer's drugs only temporarily ease symptoms.

Woodcock has been serving as the agency's acting commissioner since January. Previously she spent more than 25 years directing the agency's drug center. While widely respected among government and drug industry circles, she has also been criticized for often pushing aggressively to approve new therapies, even when their benefits aren't certain.

Biogen
Biotechnology company Biogen, maker of the new Alzheimer's drug Aduhelm, in Cambridge, Massachusetts. Dominick Reuter/AFP via Getty Images