Here's a much more specific response (from http://www.fdareview.org/harm.shtml http://www.fdareview.org/harm.shtml): Gieringer (1985) used data on drug disaste

Here's a much more specific response (from http://www.fdareview.org/harm.shtml http://www.fdareview.org/harm.shtml): Gieringer (1985) used data on drug disasters in countries with less-stringent drug regulations than the United States to create a ballpark estimate of the number of lives saved by the extra scrutiny induced by FDA requirements. He then computed a similar ballpark figure for the number of lives lost owing to drug delay: [T]he 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. . . . Given the uncertainties of the data, these results must be interpreted with caution, although it seems clear that the costs of regulation are substantial when compared to benefits. (196) In short, that paper estimates the FDA has killed more than twice as many people as it has saved. The reference: "Gieringer, D. H. 1984. Consumer Choice and FDA Drug Regulation. Ph.D. diss., Department of Engineering-Economic Systems, Stanford University." Here's another really good (and SHORT) general overview article that should address a lot of your concerns, "Economists Against the FDA" by Daniel B. Klein: http://www.scu.edu/civilsocietyinstitute/articles/upload/EconagainstFDA.pdf http://www.scu.edu/civilsocietyinstitute/articles/upload/Eco... When I said that delaying good drugs and good drug information kills, by drug information I meant stuff like this (from the Klein article): Today men with risk of heart trouble know to take half an aspirin a day. By 1988 it was well established that aspirin greatly reduces the risk of myocardial occlusion. But for years the FDA forbade aspirin makers from advertising that fact (the FDA still significantly restricts advertising about it). The FDA surely killed tens, and quite possibly hundreds, of thousands of Americans by this restriction alone."