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The Effects of Regulation,
This review is from: Regulation of Pharmaceutical Innovation: The 1962 Amendments (Evaluative Studies 15) (Paperback)
Regulation of Pharmaceutical Innovation: The 1962 Amendments by Sam Peltzman concludes that the 1962 ("proof of efficacy") amendments to the Food, Drug and Cosmetic Act of 1938 (1) have cut the number of new drugs (new chemical entities) brought to the market each year by half with no corresponding reduction in inefficacious drugs, (2) have doubled the costs of drug development, (3) have have increased drug prices by reducing competition among drugs (so that the sick pay $50 million more each year for drugs), and (4) have imposed substantial net social costs from death and illnesses that could have been prevented if the development of new drugs had not been hampered by the amendments. These conclusions are reached dispite the fact that Professor Peltzman has assumed for the amendments benefits that cannot be proven and may not have taken place. -- from book's back cover
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