Writing in the Wall Street Journal, Charley Hooper and David Henderson wisely make the case against the absurd 1962 Kefauver-Harris amendment that FDA approval be given, not to drugs that are proven merely to be “safe,” but only to those that are proven to be both “safe and effective. ” A slice:
Further, the Kefauver-Harris Amendments dramatically increased the time and cost of getting new drugs approved. Evidence provided by University of Chicago economist Sam Peltzman suggests that the number of new drugs approved dropped by 60% in the decade following the law change. We have fewer ineffective drugs, but also far fewer effective ones than we could have had.