Post by icemandios on Jul 7, 2021 17:33:39 GMT
July 7, 2021 07:31 AM EDT PharmaFDA+
Rep. Porter calls on HHS inspector general to investigate FDA-Biogen ties prior to Aduhelm's approval
Josh Sullivan
Associate Editor
Following the House Oversight Committee’s call to investigate the approval and price of Biogen’s new Alzheimer’s drug, Rep. Katie Porter (D-CA) is now calling on HHS’ inspector general to investigate the cozy relationship between the FDA and Biogen ahead of that approval.
The fallout over the Aduhelm approval continues in her letter Tuesday as Porter calls for a full review of all agency practices in meeting with pharmaceutical companies and to establish new internal policies.
Patients should have confidence that their treatment plans are based on science, not cozy relationships between Big Pharma and @us_FDA officials. I'm concerned the approval process for certain drugs has been compromised, so I'm urging an independent watchdog to investigate. pic.twitter.com/LgLzcIGVnN
— Rep. Katie Porter (@repkatieporter) July 6, 2021
Over the years, Porter has developed a reputation for her tough questioning of officials during hearings and her investigations into egregious pharmaceutical company practices.
“While families and patients deserve to have access to urgently needed treatments, the violation of well-established rules regarding communications between scientists and manufacturers and the subsequent misuse of approval and contracting pipelines, is unacceptable,” the letter says. “We cannot put big pharmaceutical companies before patients’ health.”
The letter outlines Biogen’s timeline to approval, mentions its failed trial in spring 2019, and mentions a lost lawsuit over its multiple sclerosis drug Tecfidera, which at one point, made up for 50% of the company’s revenue. It also mentions the secret campaign created by Biogen executives, dubbed Project Onyx, and calls out the company for meeting with FDA neuro chief Billy Dunn off the books.
A report from STAT last week revealed that Biogen executives and Dunn held conversations about the use of the accelerated approval pathway to push Aduhelm through the approval process as early as 2019. While such conversations are well within the bounds of FDA’s regulations, a former Biogen employee told STAT that it was “clear that Billy Dunn was an ally, so the job for Biogen became figuring out how to support his efforts within the FDA.”
The sticker price on the drug is $56,000, a number that threatens to speed the bankruptcy of Medicare.
“It appears very clear that Biogen had an inside route to FDA officials and had undue influence over their decision making and the evidence presented in various settings,” Porter writes. “While I respect the FDA’s scientific expertise, it has become clear through various cases, including Rick Bright’s whistleblower suit last year and the recent approval of Aduhelm, that too many pharmaceutical executives, lobbyists and other stakeholders have long had inappropriate access to officials throughout the Department of Health and Human Services.”
Rep. Porter calls on HHS inspector general to investigate FDA-Biogen ties prior to Aduhelm's approval
Josh Sullivan
Associate Editor
Following the House Oversight Committee’s call to investigate the approval and price of Biogen’s new Alzheimer’s drug, Rep. Katie Porter (D-CA) is now calling on HHS’ inspector general to investigate the cozy relationship between the FDA and Biogen ahead of that approval.
The fallout over the Aduhelm approval continues in her letter Tuesday as Porter calls for a full review of all agency practices in meeting with pharmaceutical companies and to establish new internal policies.
Patients should have confidence that their treatment plans are based on science, not cozy relationships between Big Pharma and @us_FDA officials. I'm concerned the approval process for certain drugs has been compromised, so I'm urging an independent watchdog to investigate. pic.twitter.com/LgLzcIGVnN
— Rep. Katie Porter (@repkatieporter) July 6, 2021
Over the years, Porter has developed a reputation for her tough questioning of officials during hearings and her investigations into egregious pharmaceutical company practices.
“While families and patients deserve to have access to urgently needed treatments, the violation of well-established rules regarding communications between scientists and manufacturers and the subsequent misuse of approval and contracting pipelines, is unacceptable,” the letter says. “We cannot put big pharmaceutical companies before patients’ health.”
The letter outlines Biogen’s timeline to approval, mentions its failed trial in spring 2019, and mentions a lost lawsuit over its multiple sclerosis drug Tecfidera, which at one point, made up for 50% of the company’s revenue. It also mentions the secret campaign created by Biogen executives, dubbed Project Onyx, and calls out the company for meeting with FDA neuro chief Billy Dunn off the books.
A report from STAT last week revealed that Biogen executives and Dunn held conversations about the use of the accelerated approval pathway to push Aduhelm through the approval process as early as 2019. While such conversations are well within the bounds of FDA’s regulations, a former Biogen employee told STAT that it was “clear that Billy Dunn was an ally, so the job for Biogen became figuring out how to support his efforts within the FDA.”
The sticker price on the drug is $56,000, a number that threatens to speed the bankruptcy of Medicare.
“It appears very clear that Biogen had an inside route to FDA officials and had undue influence over their decision making and the evidence presented in various settings,” Porter writes. “While I respect the FDA’s scientific expertise, it has become clear through various cases, including Rick Bright’s whistleblower suit last year and the recent approval of Aduhelm, that too many pharmaceutical executives, lobbyists and other stakeholders have long had inappropriate access to officials throughout the Department of Health and Human Services.”