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Invisible Monuments and the Costs of Pharmaceutical Regulation: Twenty-five Years of Drug Lag Debate
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This paper reviews the drug lag issue, a highly-politicized debate about the speed with which new drugs are approved in the United States from its start in the early 1970s through its apparent resolution in the mid-1990s. Daemmrich argues that throughout the debate, different visions of "the patient" were at stake. Winners at any given moment were those who could best portray in an easily visualized or better yet, actually visible, victimized patient. During the 1970s, critics portrayed an abstract, often invisible patient who suffered due to the delay in approving helpful therapeutics. The FDA, on the other hand, described an easily visualized patient that needed protection from the pharmaceutical industry. This patient was readily seen on television and in print due to media attention to the deformed children born during the thalidomide tragedy and other victims of adverse drug reactions. In the 1980s and early 1990s, however, the tables turned. Critics, now including cancer and AIDS activists, gave a visible face to patients needing more rapid access to new drugs. The FDA initially tried to retain its precautionary stance based on the potential harm of side effects, but then relented and changed regulatory procedures. As a result, new drugs came on the market more quickly, ending the political saliency of comparisons with approval rates in other countries. Though no longer a burning political issue, drug approval rates have longer-term implications in contemporary disputes about the costs and duration of clinical testing.
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