Word: fda
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Dates: during 1960-1969
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...Duty. Personalities and minor issues aside, the crucial debate in and around FDA centers on the question: How shall it discharge its duty to protect the public against useless or dangerous drugs? There can be no simple answer because the law, and therefore the duty, have changed almost as fast as drugs have changed...
...FDA got a shot of growth hormone in 1962 with the Kefauver-Harris law, which made the agency responsible for the efficacy as well as the safety of new drugs. But growth (from 800 employees and a $5,000,000 budget in 1955 to 4,400 and $53 million today) also meant growing pains. FDA was ill organized and ill housed-some of its most vital scientific work had to be done in a made-over garage. Worse, many of its difficulties were homemade...
...along among themselves. Things looked up for a while after Dr. Frances O. Kelsey became a heroine for keeping thalidomide off the U.S. market, and after Dr. Joseph F. Sadusk Jr., with a good record as a medical educator and a practicing physician, took over as head of FDA's Bureau of Medicine (TIME, March 13, 1964). But now the Kelsey faction is warring on Sadusk, who is also the target of Representative Lawrence H. Fountain's Intergovernmental Relations Subcommittee...
...sharpest division is over how hard FDA should bear down on drug safety. Dr. Sadusk was at first expected to favor strict enforcement. But he is convinced that practicing physicians should be free to make their own choices from among many available drugs, all of which have some degree of danger. His opponents now accuse him of betraying the public interest in favor of protecting the pharmaceutical manufacturers. Some recent examples of action, inaction and disputed decisions: ≫ SULFAS. FDA last week announced that it was requiring new labeling on two long-acting sulfa drugs marketed by three firms...
...CHLORAMPHENICOL. For 15 years FDA has struggled with the problem of how to label and whether to restrict the use of this antibiotic (Parke, Davis' Chloromycetin). It is unquestionably the best drug against half a dozen uncommon diseases and a few medical conditions that should be treated in hospitals. But it is often prescribed to avert the aftereffects of a common cold, for which it is useless and also dangerous, because it may cause death from anemia...