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FDA calls for probe of staff involved in divisive Alzheimer’s approval

The acting head of the US Food and Drug Administration has taken the unusual step of calling for an independent investigation into the agency’s interactions with Biogen’s executives in the run-up to the approval of the company’s Alzheimer’s drug.

Janet Woodcock, acting head of the FDA, wrote to the inspector general of the Department for Health and Human Services on Friday, asking for a review of correspondence between her staff and Biogen’s executives as questions mount over why the regulator approved the contentious drug.

Pressure had been building on the agency after Stat News last month reported that Biogen had in 2019 held an off-the books meeting with Billy Dunn, head of the FDA’s neuroscience division, to enlist his support for the treatment that is now known as Aduhelm.

Shares in Biogen fell 3 per cent in afternoon trading in New York.

Last month, the FDA gave a green light to Biogen’s Alzheimer’s drug, making it the first treatment for the disease to be authorised in nearly 20 years. The agency subsequently came under fire from scientists who said the drug should not have been approved because there is scant evidence it works.

Some critics argued the approval was a sign the FDA is too close to the pharmaceutical industry.

Woodcock on Friday wrote that she had “tremendous confidence” in the commitment of her staff “to unbiased and science-based decision-making”. But she noted that there were concerns “regarding contacts between representatives from Biogen and FDA during the review process, including some that may have occurred outside the formal correspondence process”.

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

Woodcock’s call for an investigation comes a day after the FDA changed its prescribing recommendations for the drug. The agency had initially recommended it be given to anyone with Alzheimer’s but on Thursday it said the treatment should be initiated only for people suffering from mild forms of the disease.

The FDA made the change after Biogen took the highly unusual of step of asking the agency to narrow the drug’s so-called label.


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