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Both Eli Lilly and the Food and Drug Administration point out that Prozac was extensively tested on more than 5,600 patients and that at least 2 million people worldwide have taken the drug. The FDA, which monitors reports of adverse reactions to drugs, sees no worrisome pattern to date. "Even if we got several hundred reports involving suicide and Prozac, we wouldn't be alarmed, given how many people use the drug and the nature of the disease," notes Dr. Paul Leber, director of the FDA's division of neuropharmacological drug products. "Depressed people commit suicide." Nonetheless, the agency...
Testing. Under pressure from AIDS activists, the FDA has radically changed its regulations for testing new drugs. The Administration has proposed "parallel track" legislation that would make drugs available to certain patients before the usual testing process is complete. Nothing wrong with this. But this exception is for AIDS patients only -- a fact that hardly supports the thesis that government is holding back an AIDS cure or discriminating against AIDS patients...
Since many of the diet products are foods or drugs, the Food and Drug Administration is a logical candidate to take the lead in overseeing the industry, but the agency has been dillydallying on this issue for years. As long ago as 1982, the FDA began drafting regulations to cover over-the-counter weight-loss products, and those proposals may at last be finalized before the end of the year. The new rules are expected to outlaw more than 100 diet- product ingredients on the market, including methyl cellulose and other bulking agents that supposedly "swell" in the consumer...
More important, the FDA is embarking on an overhaul of labeling requirements for processed foods. That effort should most definitely include the products of diet programs. Even industry executives agree there should be uniform rules governing what claims can be made and what caveats must be listed. If consumers have more information, they will be in a better position to decide which diet plans are worth the money...
...surge in deaths during early testing of the medication DDI raises questions about relaxed FDA regulations. -- Nuns and priests are sought for Salk's anti- AIDS tests...