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> Most reasonable people would agree that the FDA is a net positive. A 1974 study by University of Chicago economist Sam Peltzman concluded that since 1962 the
by waterhouse 8y ago
> Most reasonable people would agree that the FDA is a net positive.
A 1974 study by University of Chicago economist Sam Peltzman concluded that since 1962 the new rules had reduced the rate of introduction of effective new drugs significantly—from an average of forty-three annually in the decade before the amendments to just sixteen annually in the ten years afterward.
... The severest criticism leveled at the drug lag is that without access to a drug available elsewhere, seriously ill patients will suffer or even die. Peltzman raised the subject in his 1974 study. He noted pharmacologist William Wardell's estimate that because the relatively safe hypnotic drug nitrazepam was not cleared for use in the United States until 1971, five years after it was available in Britain, more than 3,700 Americans may have died from less safe sedatives and hypnotics. After earning the Nobel Prize for chemistry in 1988, U.S. drug researcher George Hitchings of Burroughs Wellcome Company said of an antileukemia drug he helped develop before the 1962 amendments: "We went from synthesis to the commercial drug in three years. That is absolutely impossible today."
http://www.econlib.org/library/Enc1/DrugLag.html http://www.econlib.org/library/Enc1/DrugLag.html
At this rate, the benefits of FDA regulation relative to that in foreign countries could reasonably be put at some 5,000 casualties per decade, or 10,000 per decade for worst-case scenarios. In comparison, it has been argued above that the cost of FDA delay can be estimated at anywhere from 21,000 to 120,000 lives per decade. These figures would seem to support the conclusion that the costs of post—1962 regulation outweigh benefits by a wide margin, similar to Peltzman's results of a 4:1 cost-benefit ratio for the 1962 amendments.
"The Safety and Efficacy of New Drug Approval", https://pdfs.semanticscholar.org/feb9/53ab293f24a14b3b3d4b748281420099b4b1.pdf https://pdfs.semanticscholar.org/feb9/53ab293f24a14b3b3d4b74...