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Monday, August 2, 2021

Democrats demand docs about Biogen, FDA coordination on Aduhelm

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WASHINGTON — Two powerful House Democrats on Monday demanded documents from Biogen about the approval process, marketing, and pricing of its controversial new Alzheimer’s drug.

The letter is the latest move 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 revealed Biogen had an off-the-books meeting with a prominent FDA regulator ahead of the drug’s unprecedented approval, and that the back-channel relationship between the two started earlier and was far more extensive than disclosed.

“Recent reporting indicates that in the months following its failed clinical studies, Biogen undertook a secret campaign, termed Project Onyx, to persuade FDA to approve Aduhelm,” Maloney and Pallone wrote.

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Acting FDA Commissioner Janet Woodcock on Friday called for an independent watchdog to investigate whether any interactions between FDA staff and Biogen violated FDA policies.

The committee is also seeking documents related to Biogen’s role in an FDA move last week to narrow prescribing guidelines to patients with the earliest stages of Alzheimer’s, as opposed to any patient with the disease. STAT reported that even some senior FDA officials were surprised by the decision for such a wide initial label, and a source close to Biogen told STAT that the company wanted a narrower label “from the start, but was reluctant to push back on FDA’s desire for a broader label for fear it could derail approval.”

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The wide-ranging request, addressed to Biogen CEO Michel Vounatsos, encompasses any documents related to the safety or clinical benefit of Aduhelm, related to the regulatory review process (including Project Onyx), related to any formal and informal meetings between Biogen and the FDA, related to the amounts Biogen spent on testing the drug and the amounts of related tax credits, or related to Biogen’s pricing and marketing strategies for Aduhelm.

The committee chairs gave Biogen until July 26 to produce the documents.

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Tracy Carr
Tracy is a veteran journalist and medicine graduate. she mostly writes about the health industry and biotech.
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