Among the U.S. Food and Drug Administration's responsibilities are approval and regulation of pharmaceutical drugs.
With respect to the Food and Drug Administration, a type I error is the rejection or delayed approval of a drug that is safe and effective-erring on the side of over-caution-and a type II error is the approval of a drug that has unanticipated dangerous side effects, or erring on the side of under-caution.
Let's examine the incentives of Food and Drug Administration officials.
Their suffering and/or death will be chalked up to the state of medicine rather than the status of a Food and Drug Administration drug application.
Finally, in 1981, the Food and Drug Administration approved the first such drug, boasting that it might save up to 17,000 lives per year.
It thinks Congress should allow drug manufacturers to provide information about "Off-label use." This is a common practice in which doctors prescribe Food and Drug Administration-approved drugs to treat conditions other than those the agency originally approved them for after new beneficial uses arise.
Strong evidence of the agency's over-caution bias comes in the 1974 words of then-Food and Drug Administration Commissioner Alexander M. Schmidt: "In all of FDA's history, I am unable to find a single instance where a congressional committee investigated the failure of FDA to approve a new drug."
https://www.dailysignal.com/2018/12/19/the-food-and-drug-administrations-invisible-victims/
With respect to the Food and Drug Administration, a type I error is the rejection or delayed approval of a drug that is safe and effective-erring on the side of over-caution-and a type II error is the approval of a drug that has unanticipated dangerous side effects, or erring on the side of under-caution.
Let's examine the incentives of Food and Drug Administration officials.
Their suffering and/or death will be chalked up to the state of medicine rather than the status of a Food and Drug Administration drug application.
Finally, in 1981, the Food and Drug Administration approved the first such drug, boasting that it might save up to 17,000 lives per year.
It thinks Congress should allow drug manufacturers to provide information about "Off-label use." This is a common practice in which doctors prescribe Food and Drug Administration-approved drugs to treat conditions other than those the agency originally approved them for after new beneficial uses arise.
Strong evidence of the agency's over-caution bias comes in the 1974 words of then-Food and Drug Administration Commissioner Alexander M. Schmidt: "In all of FDA's history, I am unable to find a single instance where a congressional committee investigated the failure of FDA to approve a new drug."
https://www.dailysignal.com/2018/12/19/the-food-and-drug-administrations-invisible-victims/
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