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ala26 replied to the topic FDA rules too strict? in the forum Regulatory Basics for Medical Devices 6 years, 6 months ago
I recently read an article that was published in 2015, that discussed if the FDA was being to strict and the consequences from it. The article argues that the FDA is strict because there are more severe consequences from approving a bad drug than failing to approve a good drug. It’s difficult to take a side here because if the FDA was not strict and approved most drugs, they risk a lot of people getting sick or dying. The other issue is that the FDA being too strict really does limit the opportunity of putting out drugs that may be successful in helping people. The article also states that failing to approve a good drug is more costly. And by costly in terms of the possibility of treating a severe disease.
Maybe what the FDA could consider is the severity of the disease the drug will treat. Will the person die with or without the drug? If they will, maybe the process for drugs that will be used for severe diseases should be less conservative.