FDA seeks probe into communications between its staff and Biogen after controversial approval of Alzheimer's drug

Daily Mail ^ | July 9, 2021 | Mansur Shaheen

[CheshireTheCat]

The U.S. Food and Drug Administration (FDA) had asked for a federal investigation into its approval of a controversial Alzheimer's drug.

Dr Janet Woodcock, acting commissioner of the FDA, announced she sent a letter to the Office of Inspector General of the U.S. Department of Health & Human Services for a probe into communications between FDA staff and Biogen Inc representatives in the lead up to the approval of Aduhelm, the company's Alzheimer's drug.

'Given the ongoing interest and questions, today I requested that [The Office of the Inspector General] conduct an independent review and assessment of interactions between representatives of Biogen and FDA during the process that led to the approval of Aduhelm,' she wrote on Twitter on Friday.

Aduhelm received FDA approval on June 7 despite limited data that it worked in clinical trials....

[CheshireTheCat]

I really don't think the FDA would approve of a drug that doesn't work or would be bad for people, now would they?

[Flick Lives]

The large price tag of the drug has been a point of concern as
A year of treatment using the drug will cost $56,000 a year, a huge premium to the $10,000 to $20,000 the drug was expected to cost.

..,

An analysis published by the Kaiser Family Foundation estimated that if just 500,000 Medicare recipients are prescribed Aduhelm, it would cost Medicare nearly $29 billion a year, far more than any other medication.

—

This is insane.

[Steely Tom]

I peered through the front window of Biogen when it was a little street-level office and laboratory near MIT, a modernistic facade on an older building. This would have been in about 1979. I had gone to the Bitter lab on Albany street for an interview (at Alcator C, which position I didn't get), and the small sign that read "Biogen," made me curious because I didn't associate MIT with biological spin-offs. It was closed, and when I peered through one of the large, vertical panes of tinted glass, could see an office with a receptionist's station and a much bigger "Biogen" sign on the wall behind it.

I remember thinking "I wonder if I'll ever hear of this outfit again." Not too many years later, I did indeed hear of it again.

[Bikkuri]

[LegendHasIt]

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