The US agency FDA has been at the center of a scandal that undermines the credibility of its decisions in such a fragile era as the pandemic.
The head of the department, Janet Woodcock, called on the federal authorities to conduct an independent investigation into the circumstances of the certification of a new drug for Alzheimer’s disease, as it turned out that representatives of the FDA worked closely with the creator of the drug, Biogen Inc.
On Friday, the contents of a letter sent by Janet Woodcock to the Inspector General of the US Department of Health, which oversees the activities of the FDA, became known.
The drug Aduhelm was approved on June 7, despite objections from some FDA experts regarding the cost of the drug (56 thousand dollars a year) and doubts about its effectiveness. Reuters reports that three of the 11 members of the FDA scientific council have resigned in protest against the certification of Aduhelm. Two rounds of clinical trials of this drug have not proved its effectiveness.
It turned out that while the drug was waiting for FDA approval, agency employees met with the company’s management. They worked together on a report that was intended for the board of independent advisers of the FDA.
The fact of improper cooperation of state supervision employees with the manufacturer of the drug became known to the most influential American NGO for consumer protection Public Citizens. Back in December last year, the head of the health department at the NGO called on the Ministry of Health to conduct a broad investigation to find out when Janet Woodcock learned about cooperation with Biogen, and whether she did not maintain these close contacts. He is quoted by the Wall Street Journal.
In the end, the head of the FDA was forced to ask the department to conduct an investigation herself. “Her letter is more of a maneuver to reduce pressure on the FDA: she does not question the decision to certify the drug, but only asks to find out the nature of the interaction of her employees with the company,” commented an analyst at the investment company Sofitel.
Against this background, Biogen’s shares fell sharply (-3%) in price on Friday trading on the New York Stock Exchange.