Beyond just its repeal it’s also how the safety studies are conducted. Are FDA employees former pharma. There needs to be complete separation ensured to provide true oversight and scientific rigor to drug approvals. Perhaps there could be reforms in the phasing of approval depending on the context of the IND etc, but many of these are already there. But the real question was the premise for why drugs need to be rapidly approved in the first place. Everytime I hear “to bring lifesaving drugs to more patients” == “we want to sell this fast.” Solid safety may rarely line up a fast approval, or result in approved drugs that are inconsistent like Aduhelm. These types of changes may also likely benefit the clinical diagnostic industry which is now under FDA purview.
By the way this was a great article and the main idea here is that all changes need to be made to benefit the patient…the history of the FDA was to protect people, not to sanction sales of a drug…not to mention we haven’t talked about food safety here. 😁. Enjoy your posts Jennifer!
Beyond just its repeal it’s also how the safety studies are conducted. Are FDA employees former pharma. There needs to be complete separation ensured to provide true oversight and scientific rigor to drug approvals. Perhaps there could be reforms in the phasing of approval depending on the context of the IND etc, but many of these are already there. But the real question was the premise for why drugs need to be rapidly approved in the first place. Everytime I hear “to bring lifesaving drugs to more patients” == “we want to sell this fast.” Solid safety may rarely line up a fast approval, or result in approved drugs that are inconsistent like Aduhelm. These types of changes may also likely benefit the clinical diagnostic industry which is now under FDA purview.
It's a valid point. We need a starting point for change and this one has been on my mind for a few years now.
By the way this was a great article and the main idea here is that all changes need to be made to benefit the patient…the history of the FDA was to protect people, not to sanction sales of a drug…not to mention we haven’t talked about food safety here. 😁. Enjoy your posts Jennifer!