WASHINGTON — Two highly effective House Democrats on Monday demanded paperwork from Biogen about the approval course of, advertising, and pricing of its controversial new Alzheimer’s drug.
The letter is the newest transfer in a congressional investigation into Aduhelm’s approval and pricing spearheaded by House Committee on Oversight and Reform Chair Carolyn Maloney (D-N.Y.) and Energy and Commerce Chair Frank Pallone (D-N.J.). The request prominently references a STAT investigation that exposed Biogen had an off-the-books assembly with a distinguished FDA regulator forward of the drug’s unprecedented approval, and that the back-channel relationship between the 2 began earlier and was much more in depth than disclosed.
“Recent reporting signifies that within the months following its failed medical research, Biogen undertook a secret marketing campaign, termed Project Onyx, to influence FDA to approve Aduhelm,” Maloney and Pallone wrote.
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Acting FDA Commissioner Janet Woodcock on Friday known as for an impartial watchdog to analyze whether or not any interactions between FDA employees and Biogen violated FDA insurance policies.
The committee can also be looking for paperwork associated to Biogen’s position in an FDA transfer final week to slender prescribing pointers to sufferers with the earliest levels of Alzheimer’s, versus any affected person with the illness. STAT reported that even some senior FDA officers had been shocked by the choice for such a large preliminary label, and a supply near Biogen informed STAT that the corporate wished a narrower label “from the beginning, however was reluctant to push again on FDA’s need for a broader label for worry it might derail approval.”
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The wide-ranging request, addressed to Biogen CEO Michel Vounatsos, encompasses any paperwork associated to the security or medical good thing about Aduhelm, associated to the regulatory evaluation course of (together with Project Onyx), associated to any formal and casual conferences between Biogen and the FDA, associated to the quantities Biogen spent on testing the drug and the quantities of associated tax credit, or associated to Biogen’s pricing and advertising methods for Aduhelm.
The committee chairs gave Biogen till July 26 to supply the paperwork.
https://www.statnews.com/2021/07/12/powerful-house-democrats-demand-documents-from-biogen-about-coordination-with-fda-on-new-alzheimers-drug/
