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Wurtman says health food stores began selling tryptophan as a nutritional supplement and sold it for 15 years without approval from the Food and Drug Administration (FDA...
...easier time quitting if Dr. C. Everett Koop can convince a Food and Drug Administration advisory panel to make Nicorette gum available without a prescription. The former Surgeon General told the committee today that nicotine gum has proven its effectiveness in helping smokers quit. "If anyone can convince the FDA to do this, it's probably Koop, who is still seen as America's doctor," notes health care writer Janice Castro. "Until now, nicotine gum has been controlled for fear that users would reinforce their addiction to nicotine." At today's meeting, several medical experts said that tests show users...
Still, opposition is mounting. More than 40 critics, including physicians, pharmacologists and other skeptics (among them a former Time senior editor), have petitioned the FDA to require that homeopathic preparations meet the same standards of safety and efficacy as other drugs. The agency, which until now has had a hands-off policy toward homeopathic cures, has sent warning letters to several firms that market remedies for serious illnesses that require a physician's supervision...
...label prescribing so common? Chiefly because pharmaceutical companies are reluctant to invest the time and expense to get FDA clearance on new uses for an established drug--especially when the drug's safety has already been proved. Says Dr. Martin Raber, physician in chief of the M.D. Anderson Cancer Center in Houston: "It is accepted practice that once a drug is FDA-approved it can be freely used." But the FDA gets nervous when a drug's unapproved uses overshadow its original purpose. Retin-A cream, for example, was approved by the FDA for the treatment of acne...
...might be expected, officials at the FDA are not sure the proposal is a good idea. "The journals are not always right," argues William Schultz, one of the agency's deputy commissioners. And there is nothing to stop companies from sending only those articles that mention their products favorably and omitting negative reports. The worst outcome, say critics, would be if manufacturers used the relaxed rules to adopt a sort of bait-and-switch research program. They could, for example, seek approval from the FDA for an indication that is easy and inexpensive to prove but not widely useful. Then...