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.
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.
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.
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.
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.