How cozy is too cozy? FDA and Biogen offer up a test case
As the saga over how to pay for Aduhelm plays out, biopharma companies are now looking closely at how Biogen was able to keep such a special relationship with FDA officials ahead of the drug’s accelerated approval, and whether or not they might be able to leverage those takeaways into their own relationships with the agency.
What makes Biogen unique, however, is how deep its relationship with the FDA ran, and the way in which FDA’s neuroscience head Billy Dunn worked alongside the company for years prior to Aduhelm’s quick OK. For instance, back in 2017, Dunn co-chaired a data sharing initiative at the nonprofit C-Path Institute alongside Biogen SVP Samantha Budd Haeberlein, as first reported by the New York Times. In 2018, Dunn and Budd Haeberlein also jointly presented on strengthening communication across the Alzheimer’s drug development community.
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