Dr. Janet Woodcock made the announcement via Twitter. This is the latest fallout from last months approval Aduhelm, an unproven and expensive therapy that the agency approved against the advice of outside experts.
Woodcock requested the Department of Health and Human Services inspector general to investigate the FDA and other federal agencies. After numerous requests from consumer advocates, medical professionals, and members of Congress for an investigation into the approval, this move was made. Two congressional committees already have launched their own review.
Woodcock tweeted that "we believe an independent assessment will be the best way to determine if any interactions between the manufacturer's review staff and FDA's policies or procedures." Biogen has pledged to cooperate in the investigation.
The unusual collaboration between Aduhelm drugmaker Biogen staff and FDA staff was reported by Stat last month. The site reported on a May 2019 "off-the-books” meeting between a Biogen executive and FDA's lead Alzheimer's drug reviewer.
Biogen had stopped two studies to determine if the drug was slowing down the disease. The FDA and Biogen began to reanalyse the data together and concluded that the drug might actually work. Two years later, the conditional approval of the drug was granted by the FDA. This was due to the fact that the drug reduced the amount of sticky plaque that has been linked to Alzheimer's disease.
FDA interactions with staff from the drug industry are closely controlled and meticulously documented. It is not clear if the May 2019 meeting was in violation of agency rules.
The FDA panel was almost unanimous in rejecting the FDA's November rejection of the drug brought by Biogen and FDA.
The FDA is not required to follow the advice of the group. The FDA's lead staff reviewer, who had worked with Biogen for several months on the data, called it "exceptionally persuasive", "strongly positive" as well as "robust."
Public Citizen, a consumer advocacy group, demanded an investigation into the collaboration following the November advisory meeting. Woodcock's request to inquire was welcomed by Dr. Michael Carome, the group's director of health.
Carome stated, "We are pleased to see that she has late made this request that should've been made months ago." "The signs that this was an inappropriate collaboration were evident to us since November."
Since approving the drug at $56,000 per year, and requiring monthly IVs, the FDA has been subject to a lot of backlash.
Three FDA advisors who opposed the drug quit over the decision. They also protested that FDA did not disclose it was considering approval of the drug on conditional grounds. This was based on the drug's effect on brain plaque rather than its actual benefit for patients. Aduhelm was the first Alzheimer's drug to be approved in this manner.
"I believe all of the parts of this decision are worth an independent investigation," Dr. Aaron Kesselheim from Harvard University, one of three advisors who resigned. "It is vital that we trust FDA's ability make independent decisions.
The FDA made an unusual decision on Thursday by drastically reducing prescribing information for the drug. Biogen and the FDA announced that the new label would only recommend that it be used for patients suffering from mild or early-stage Alzheimer's. Many doctors had criticized the original label for being too broad. It stated that the drug could be administered to anyone suffering from Alzheimer's.
Aduhelm has not been shown to significantly slow down or reverse the effects of the disease. However, the FDA stated that Aduhelm's ability to reduce plaque buildup in the brain may slow down dementia. This approach has been tried by more than twenty-six other drugs without any positive results. To determine if it works, Biogen must conduct a follow up study. Others Alzheimer's medications only temporarily relieve symptoms.
Woodcock is the agency's acting chief commissioner since January. Woodcock spent over 25 years as the agency's director of its drug center. Although she is respected by the government and drug industry circles, her aggressive push to approve new therapies has been criticised.