A parliamentary report pointed out this Thursday to the United States Medicines Agency, the FDA, for having carried out an authorization process “full of irregularities” of a new drug against Alzheimer’s, called Aduhelm, and whose commercialization in 2021 had unleashed the controversy. The report also blames the American laboratory Biogen, which markets this drug, for having set a very high price in an “unjustified” way ($56,000 per year), in order to “maximize” its benefits.
“I hope these results raise awareness about the FDA,” Carolyn Maloney, Democrat-elect from New York state, who headed one of two congressional committees that conducted this 18-month investigation, said in a news release.
closeness criticized
The FDA gave the green light in early June 2021, through an accelerated procedure, to this treatment, which was the first approved against Alzheimer’s disease since 2003. But this decision has caused a sensation in the scientific and medical communities, with the FDA opposing it. to opinion. from an expert committee, which had judged that the treatment had not sufficiently demonstrated its efficacy in clinical trials. Several members subsequently resigned from the committee in protest.
Under pressure, the agency finally announced that it would restrict the use of the drug to people with moderate cases of the disease. According to the Chamber’s report, “FDA’s interactions with Biogen were atypical” prior to authorization, and the agency did not track all interactions between its employees and those of the company, as is normally required.
The FDA and Biogen also worked on a joint document to present to the expert committee, a proximity criticized by the report. “It is the agency’s job to engage frequently with companies to ensure that we have the right information for our decision making,” the FDA said in a statement.
“Our ambition is to make history”
However, “the agency has already begun to implement changes in line with the recommendations” in the report, it added. He also denounces the price set by Biogen, which he knew would penalize access to treatment for some patients.
In 2020, a company filing stated: “Our ambition is to make history” and “establish Aduhelm as one of the biggest pharmaceutical launches of all time,” the report revealed. An “aggressive marketing campaign” was planned, and consultants had advised prices above $40,000 a year to maximize revenue.
Source: BFM TV
