The FDA is calling for a study of partners who may approve of Alzheimer’s

The U.S. Food and Drug Administration’s executive director has taken the initiative to conduct an independent inquiry into Biogen’s management’s decision to finalize the $ 56,000 annual Alzheimer’s drug approval.

Janet Woodcock wrote to the director general of the department for Health and Human Services on Friday, requesting that she review the letters between FDA staff and Biogen executives if questions were raised as to why the director had approved divisive drugs.

Pressure was still growing at the agency after Stat News last month reports that Biogen held a 2019 book meeting with Billy Dunn, chief of the FDA’s neuroscience team, to provide him with medical treatment now known as Aduhelm.

Shares in Biogen fell 3% in New York on Friday.

Last month, the FDA gave a green light to Biogen’s Alzheimer’s drug, making it the first drug to be approved for nearly 20 years. he was convicted from scientists who said the drug should be rejected because there is little evidence it works.

Some critics say the approval is a sign that the FDA is very close to the pharmaceutical industry.

Woodcock on Friday wrote that he had “great confidence” in the commitment of his colleagues to “make decisions without discrimination and through the use of science”. But he noted that there were problems “related to the communication between representatives from Biogen and the FDA during this review, plus some that may have occurred outside the correspondence”.

He encouraged the illumination to begin “immediately”.

Michael Carome, head of the health research team at the Citizen humanitarian group, who called for the study, welcomed Woodcock’s suggestion.

He also said the review “should examine how Dr Woodcock promoted the culture in the FDA… Which allowed and encouraged inappropriate collaboration with regulated companies”.

Directed by Woodcock “the relationship between the FDA. . . and the pharmaceutical industry has grown tremendously ”, added Carome.

Woodcock’s request for a request came a day after the FDA changed its views on the drug. The agency recommended that it be made available to anyone with Alzheimer’s disease but on Thursday said the treatment should be started for people with a minor illness.

The FDA changed Biogen after it took an unusual step to ask the agency to reduce the name of the drug.

About 6m people in the US have Alzheimer’s disease. Biogen claims that its treatment slows the progression of the disease rather than simply reducing its symptoms.

The product is sloping $ 56,000 a year Price has raised questions about how it could affect Medicare, a government-sponsored health care program for the elderly that could be costly.

The high cost and controversy over the effectiveness of antiretroviral therapy in Alzheimer’s disease has also resurfaced research and the House Committee on Oversight and Repair.