anonymous
Guest
anonymous
Guest
Inside Biogen’s top secret campaign to get the FDA to approve Aduhelm
Biogen launched a secretive two-year campaign, dubbed Project Onyx, to convince the FDA to approve its controversial Alzheimer’s drug, Aduhelm, my colleagues Adam Feuerstein, Matt Herper, and Damian Garde scoop in a blockbuster new story for STAT.
At the center of that campaign was an effort by Biogen to win over the head of the FDA’s Office of Neuroscience, Billy Dunn. Biogen’s top scientist Al Sandrock met with Dunn in May 2019 for an off-the-books meeting shortly after Biogen announced it was halting trials of the drug, STAT reports. The meeting appeared to pay off: Dunn’s office prepared for the company an extensive road map laying out how Biogen might gain FDA approval, despite lackluster data.
The reporting is likely to inflame critics of the agency who have complained for years that the FDA acts more like a consultant to the drug industry and less like an impartial — or tough — regulator. The news will also give further fuel to critics like Public Citizen who have already called for the ouster of Dunn, and for the HHS Office of Inspector General to investigate the close collaboration between Biogen and FDA officials.
Read STAT’s explosive new exclusive here.
Biogen launched a secretive two-year campaign, dubbed Project Onyx, to convince the FDA to approve its controversial Alzheimer’s drug, Aduhelm, my colleagues Adam Feuerstein, Matt Herper, and Damian Garde scoop in a blockbuster new story for STAT.
At the center of that campaign was an effort by Biogen to win over the head of the FDA’s Office of Neuroscience, Billy Dunn. Biogen’s top scientist Al Sandrock met with Dunn in May 2019 for an off-the-books meeting shortly after Biogen announced it was halting trials of the drug, STAT reports. The meeting appeared to pay off: Dunn’s office prepared for the company an extensive road map laying out how Biogen might gain FDA approval, despite lackluster data.
The reporting is likely to inflame critics of the agency who have complained for years that the FDA acts more like a consultant to the drug industry and less like an impartial — or tough — regulator. The news will also give further fuel to critics like Public Citizen who have already called for the ouster of Dunn, and for the HHS Office of Inspector General to investigate the close collaboration between Biogen and FDA officials.
Read STAT’s explosive new exclusive here.