There is a bill in Congress to revise the way the
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Posted On: 03/08/2022 11:59:19 AM
There is a bill in Congress to revise the way the FDA handles accelerated approvals. I am not trying to imply this handicaps CYDY - just FYI on possible upcoming change. In fact they give examples of BP gaming the system (my words, not theirs).
Overhauling FDA's accelerated approval pathway: Key House committee chair pens new bill
House Energy & Commerce Committee Chair Frank Pallone (D-NJ) late Monday introduced new legislation that would revamp the way the FDA can tighten its reigns around accelerated approvals, which have seen rising numbers over the years, but no real way for the agency to quickly pull ones that have failed to confirm clinical benefit in a timely manner.
To prevent such dangling, Pallone’s bill would set time limits around accelerated approvals, such as requiring the approvals to expire one year after post-approval studies are scheduled to be complete, and never later than five years after an accelerated approval, unless the post-marketing study has been completed and verified the clinical benefit, or the HHS Secretary determines that adequate progress has been made.
Pallone said in a statement that “under the current system, some products have been allowed to stay on the market for far too long without clinical trials that demonstrate a real clinical benefit for patients. Patients deserve to know that the drugs they are taking are safe and effective.”
Under such a system, if the legislation wins support in the Senate and White House, accelerated approvals like Novartis’ in 2015 for Farydak (panobinostat) in combination with bortezomib and dexamethasone for the treatment of patients in third-line multiple myeloma may have been pulled two years ago, rather than last November. The drug was pulled by Secura Bio, which acquired the drug in 2019.
Similarly, Seagen’s Adcetris (brentuximab vedotin), which won an accelerated approval in 2011 for systemic anaplastic large cell lymphoma after the failure of at least one multi-agent chemo, might not have been able to take until 2018 to finish its confirmatory trial and win a full approval.
Biogen’s controversial new Alzheimer’s drug Aduhelm — likely one of the main reasons this bill was written — also wouldn’t be allowed to take until 2030 (the FDA’s deadline) to complete its confirmatory trial under Pallone’s bill, although Biogen has said it will finish its trial closer to 2026.
Specifically, the bill provides the FDA with a lot more discretion on how it can manage the accelerated approval program. The FDA’s Oncology Center of Excellence, which reviews the bulk of the accelerated approvals that come into the agency, held an advisory committee meeting last spring and has been working to move forward on either pulling or requiring further studies for some of these “dangling” accelerated approvals.
https://endpts.com/overhauling-fdas-accelerat...-new-bill/
Overhauling FDA's accelerated approval pathway: Key House committee chair pens new bill
House Energy & Commerce Committee Chair Frank Pallone (D-NJ) late Monday introduced new legislation that would revamp the way the FDA can tighten its reigns around accelerated approvals, which have seen rising numbers over the years, but no real way for the agency to quickly pull ones that have failed to confirm clinical benefit in a timely manner.
To prevent such dangling, Pallone’s bill would set time limits around accelerated approvals, such as requiring the approvals to expire one year after post-approval studies are scheduled to be complete, and never later than five years after an accelerated approval, unless the post-marketing study has been completed and verified the clinical benefit, or the HHS Secretary determines that adequate progress has been made.
Pallone said in a statement that “under the current system, some products have been allowed to stay on the market for far too long without clinical trials that demonstrate a real clinical benefit for patients. Patients deserve to know that the drugs they are taking are safe and effective.”
Under such a system, if the legislation wins support in the Senate and White House, accelerated approvals like Novartis’ in 2015 for Farydak (panobinostat) in combination with bortezomib and dexamethasone for the treatment of patients in third-line multiple myeloma may have been pulled two years ago, rather than last November. The drug was pulled by Secura Bio, which acquired the drug in 2019.
Similarly, Seagen’s Adcetris (brentuximab vedotin), which won an accelerated approval in 2011 for systemic anaplastic large cell lymphoma after the failure of at least one multi-agent chemo, might not have been able to take until 2018 to finish its confirmatory trial and win a full approval.
Biogen’s controversial new Alzheimer’s drug Aduhelm — likely one of the main reasons this bill was written — also wouldn’t be allowed to take until 2030 (the FDA’s deadline) to complete its confirmatory trial under Pallone’s bill, although Biogen has said it will finish its trial closer to 2026.
Specifically, the bill provides the FDA with a lot more discretion on how it can manage the accelerated approval program. The FDA’s Oncology Center of Excellence, which reviews the bulk of the accelerated approvals that come into the agency, held an advisory committee meeting last spring and has been working to move forward on either pulling or requiring further studies for some of these “dangling” accelerated approvals.
https://endpts.com/overhauling-fdas-accelerat...-new-bill/
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