WASHINGTON — On Friday, the acting FDA commissioner asked for an inquiry into extremely unusual connections between some of her agency’s drug reviewers and the developer of a contentious new Alzheimer’s drugs.
Dr. Janet Woodcock made the unexpected announcement on Twitter. It’s the latest repercussion of the FDA’s approval of Aduhelm, a costly and untested treatment that the agency approved despite the recommendation of its own independent experts last month.
The inspector general of the Department of Health and Human Services, which supervises the FDA and other federal health agencies, received Woodcock’s request. Medical professionals, consumer activists, and members of Congress have all called for an investigation into the approval. Two congressional committees have begun their own investigation.
On Twitter, Woodcock remarked, “We feel an independent evaluation is the best way to establish if any contacts between the manufacturer and the agency’s review personnel were inconsistent with FDA’s standards and procedures.”
Last month, the health news site Stat revealed numerous new details concerning Aduhelm manufacturer Biogen’s extremely tight engagement with the FDA’s medication review personnel. An unrecorded meeting between a top Biogen executive and the FDA’s chief reviewer for Alzheimer’s medicines was disclosed by the site in May 2019.
The conference came after Biogen halted two trials because the medication didn’t appear to reduce disease progression as expected. Biogen and the FDA collaborated on reanalyzing the data and came to the conclusion that the medication could actually function. The medication was conditionally approved two years later, based on the fact that it decreased the formation of sticky plaque in the brain, which is considered to have a role in Alzheimer’s disease.
Interactions between FDA officials and representatives from the pharmaceutical sector are tightly regulated and nearly always meticulously documented. It’s unclear whether the meeting in May 2019 broke any agency regulations.
Since authorizing the medication, which costs $56,000 a year and needs monthly IVs, the FDA has faced a barrage of criticism. The government took the rare step of drastically reducing prescription instructions on the medication on Thursday. The FDA and Biogen stated that the revised label will only suggest it for individuals with moderate or early-stage Alzheimer’s disease. Many physicians had questioned the initial label, which said merely that medication may be used in anybody with Alzheimer’s disease.
Aduhelm hasn’t been demonstrated to be effective in reversing or slowing the progression of the illness. However, the FDA believes that its capacity to decrease plaque clumps in the brain will likely slow dementia. Biogen is obliged to undertake follow-up research to determine if the treatment is effective. Other Alzheimer’s medicines only help with symptoms for a short time.
Since January, Woodcock has been acting as the agency’s commissioner. She previously served as the director of the agency’s narcotics center for more than 25 years. While she is well-liked in government and the pharmaceutical sector, she has been chastised for rushing to approve new medicines even when their advantages are uncertain.