Safety & Effectiveness

If the U.S. 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 further formality. The time runs out next October.

New 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 the claims made for it on the label; and 3) show that the promotion of a drug does not make more sweeping claims than are made on the label.

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 filled by a man well qualified for the grueling work: Dr. Joseph Francis Sadusk Jr., 54, of George Washington University.

New Staff. Baltimore-born Dr. Sadusk was an Army medic and served on the faculty of Yale and Stanford medical schools before he went to G.W. as a full professor and chairman of a new department of preventive medicine and community health. An experienced administrator, he is also a tough negotiator. He set his own terms for taking the FDA job, and got them. He, and all the doctors on his staff, are to have some time reserved for research or teaching. This, Dr. Sadusk believes, will ensure his being able to attract men of medical distinction.

And under the new rules, manufacturers will have to inform Dr. Sadusk immediately when they hear of bad reactions among patients taking drugs, regardless of whether the drug seems directly to blame. In honest differences of opinion, Dr. Sadusk and his staff will have the last word.

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