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Posted On: 08/04/2021 11:24:14 PM
Post# of 148908
Rep. Katie Porter wrote a letter on July 6, 2021 to the HHS Office of the Inspector General concerning pharma's influence over individuals in the Dept. of Health and Human Services. Citing the example of Aduhelm, she requested "that you immediately investigate the role that pharmaceutical industry executives, consultants, and lobbyists have in the approval of products by the Department of Health and Human Services, and specifically, in the Food and Drug Administration (FDA)." You can read the 4-page letter here. I have not been able to find it anywhere other than on Twitter.
https://twitter.com/RepKatiePorter/status/141...14/photo/1
The Inspector General's office announced this:
https://oig.hhs.gov/reports-and-publications/...000608.asp
Review of the FDA's Accelerated Approval Pathway
The FDA recently approved Aduhelm (aducanumab) to treat patients with Alzheimer's disease using the accelerated approval pathway. The accelerated approval pathway allows the FDA to approve drugs that treat serious conditions and that fill an unmet medical need based on a surrogate endpoint, which is a marker that is thought to predict a clinical benefit. The FDA's approval of Aduhelm raised concerns due to alleged scientific disputes within the FDA, the advisory committee's vote against approval, allegations of an inappropriately close relationship between the FDA and the industry, and the FDA's use of the accelerated approval pathway. In response to these concerns, we will assess how the FDA implements the accelerated approval pathway. This will include reviewing interactions between the FDA and outside parties as well as other aspects of the process, such as deciding on this pathway and scientific disputes. We will review the FDA's relevant policies and procedures, determine compliance with them, and make appropriate findings and recommendations based on a sample of drugs approved using the accelerated approval pathway, which will include Aduhelm. We will not assess the scientific appropriateness of the FDA's approval of any of the drugs under review. This work may result in multiple reports.
I hope that the investigation leads to a deep dive into the influence big pharma has at the FDA in all aspects of approval, not just the accelerated approval pathway.
https://twitter.com/RepKatiePorter/status/141...14/photo/1
The Inspector General's office announced this:
https://oig.hhs.gov/reports-and-publications/...000608.asp
Review of the FDA's Accelerated Approval Pathway
The FDA recently approved Aduhelm (aducanumab) to treat patients with Alzheimer's disease using the accelerated approval pathway. The accelerated approval pathway allows the FDA to approve drugs that treat serious conditions and that fill an unmet medical need based on a surrogate endpoint, which is a marker that is thought to predict a clinical benefit. The FDA's approval of Aduhelm raised concerns due to alleged scientific disputes within the FDA, the advisory committee's vote against approval, allegations of an inappropriately close relationship between the FDA and the industry, and the FDA's use of the accelerated approval pathway. In response to these concerns, we will assess how the FDA implements the accelerated approval pathway. This will include reviewing interactions between the FDA and outside parties as well as other aspects of the process, such as deciding on this pathway and scientific disputes. We will review the FDA's relevant policies and procedures, determine compliance with them, and make appropriate findings and recommendations based on a sample of drugs approved using the accelerated approval pathway, which will include Aduhelm. We will not assess the scientific appropriateness of the FDA's approval of any of the drugs under review. This work may result in multiple reports.
I hope that the investigation leads to a deep dive into the influence big pharma has at the FDA in all aspects of approval, not just the accelerated approval pathway.
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