The acting head of the U.S. Food and Drug Administration took the unusual step of calling for an independent investigation of the agency’s interactions with Biogen’s executives, in case the company’s $56,000 per year Alzheimer’s drug gets controversial Approved.

Janet Woodcock wrote to the Inspector General of the Department of Health and Human Services on Friday, requesting a review of communications between FDA staff and Biogen executives because of why the relevant regulatory agencies approved Splitting drugs.

After the statistics news last month, the agency is under increasing pressure Report Biogen held an off-book meeting in 2019 with Billy Dunn, head of the FDA’s neuroscience department, to win his support for the treatment now known as Aduhelm.

Biogen’s stock price fell 3% in the afternoon trading in New York.

Last month, the FDA gave Biogen’s Alzheimer’s disease drug the green light, making it the first drug approved to treat the disease in nearly 20 years.The agency subsequently Under attack From scientists who say this drug should be rejected because there is little evidence that it works.

Some critics believe that the approval shows that the FDA has too close a relationship with the pharmaceutical industry.

Woodcock wrote on Friday that she was “very confident” in her employees’ commitment to “make fair and science-based decisions.” However, she pointed out that there are concerns about “contacts between Biogen and FDA representatives during the review process, including some contacts that may occur outside of the formal communication process.”

She urged the review to begin “as soon as possible.”

Michael Carome, director of the health research group at Public Citizen, an advocacy organization that called for investigations, welcomed Woodcock’s move.

He said that the review “must examine how Dr. Woodcock cultivates a culture within the FDA… This allows and encourages such inappropriate cooperation with regulated industries.”

Under the leadership of Woodcock, “The Relationship Between FDA”. .. The pharmaceutical industry is becoming more and more comfortable”, Carome added.

Woodcock’s request for investigation was made the day after the FDA changed its prescription recommendation for the drug. The agency initially recommended giving it to anyone with Alzheimer’s disease, but said Thursday that the treatment should only be for people with mild Alzheimer’s disease.

After Biogen took an unusual step to request the FDA to narrow the so-called label range of the drug, the FDA made a change.

In the United States, approximately 6 million people suffer from Alzheimer’s disease. Biogen claims that its treatment can slow the progression of the disease, not just relieve its symptoms.

The medicine is very strong USD 56,000 per year The cost has raised questions about its impact, that is, government-funded elderly healthcare programs will eventually bear most of the costs.

The high cost and controversy surrounding the drug’s effectiveness for Alzheimer’s disease have also triggered survey Proposed by the House of Representatives Oversight and Reform Committee.


Source link

Leave a Reply