Word: fda
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Dates: during 1960-1969
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...Food and Drug Ad ministration has its way, many a bottle is going to disappear from drugstore and medicine-cabinet shelves in the next year or so. A few have been knocked off recently, but more will go now that FDA is invoking the power to reassess all the drugs that were approved from 1938 through early 1963, to see whether they measure up to the high standards set by the "thalidomide law." That law, officially the Drug Amendments Act, passed in 1962, contained a delay clause allowing previously approved drugs to stay on the market for two years without...
...Labels. Under the law as it stood from 1938 through 1962, manufacturers merely had to satisfy FDA that drugs were safe. Whether they did any good was none of FDA's business. The new law requires manufacturers to prove effectiveness as well as safety, and FDA can demand proof of effectiveness, even if a drug has been prescribed millions of times. FDA has now told manufacturers it will require them to 1) report which pre-1963 drugs are still on the market, and how they are labeled and promoted; 2) show that doctors' experience with each drug justifies...
Nobody can yet guess how many drugs will be dropped because FDA finds them ineffective. Far more are likely to disappear because manufacturers find that it takes too much time to work out approved labeling. What is certain is that FDA is at last getting organized to do its enormous job properly. Since the Drug Amendments Act took effect last June, FDA has beefed up its staff of M.D.s and veterinarians from 65 to 101, with 25 more still being recruited. Most important of all, FDA's key drug-safety position, vacant for 18 months, has at last been...
...Durovic surrendered a sampling of Krebiozen to FDA agents last July, and at once chemists began systematic analysis with an infrared spectroscope. After the complex spectrogram was compared with that of thousands of other organic compounds, the pattern of Krebiozen was found to match that of creatine. Ironically, Krebiozen is much easier to produce than Dr. Durovic may realize; he uses benzene, in which creatine is highly insoluble, for extraction. Using plain water as a solvent for the process, he might get several hundred times more amino acid derivative from each horse...
Observing the FDA investigation were researchers from the National Bureau of Standards, the National Cancer Institute, and four universities. Even with such impeccable scientific credentials, the report is not likely to go uncontested. Krebiozen has strong emotional appeal and powerful political supporters (among them, Illinois' Senator Paul Douglas), and one of its most passionate promoters, Physiologist Andrew Conway Ivy, stubbornly insists that "creatine isn't Krebiozen. We're going ahead as in the past." But before long, the other secret of Krebiozen may be found: the National Cancer Institute is scrutinizing the records of 507 patients treated...