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. . . ATTEMPTS TO DISCOURAGE `OFF-LABEL' USAGE ARE PRUDENT

THE FOOD AND DRUG Administration is being prudent in regulating the flow of information on unapproved uses of prescription drugs.

Physicians and patients need to rely more on scientific information about drug therapy and less on the incantations of pharmaceutical companies, who have vested interests in the promotion of specific drug products.Staying abreast of new drug developments and new uses for established drugs is a challenge physicians face throughout their careers. It is widely acknowledged that pharmaceutical industry sponsored programs play an important role in informing and updating physicians on drug developments.

Pharmaceutical companies spend millions of dollars on medical symposia, hospital rounds, visiting clinical faculty, round table discussions, journal articles and special supplements and other methods of disseminating information about their products.

Many of the industry-sponsored activities can provide health-care professionals with genuine opportunities for scientific exchange, education and advancing the practice of medicine.

These activities can, however, be used also for surreptitious promotion of the sponsor's products, thereby undermining the unbiased exchange of scientific experience, promulgating unsubstantiated therapy, endangering patients and compromising professional ethics.

The FDA does not want to discourage dialogue among scientists and recognizes that educational exchanges among researchers and practitioners regarding pre-approved drugs of off-label uses of approved drugs are essential.

At the same time, the FDA does not want to encourage widespread usage of a drug for which there is insufficient definitive data.

Therefore, the FDA does not permit the pharmaceutical manufacturer to promote a product for indications that do not appear in the package insert. This proscription is meant, at least in part, to encourage the company to fund research, sponsor true educational programs and gather data in support of additional approved uses.

At present, off-label uses account for a substantial amount of prescription drug usage - possibly up to 60 percent, in the opinion of one American Medical Association officer. This has particular relevance for pediatric and oncology prac-tice.

About 80 percent of the more than 2,000 prescription drugs currently on the market in the United States have never been tested for safety or efficacy on children.

The FDA recently issued long-awaited regulations for the pediatric labeling of prescription drugs. Pharmaceutical companies soon will publish information about drug dosages for children without doing full-scale clinical testing if a disease is similar in both children and adults.

Patients should have ready access to potentially life-saving medications, but they also should be protected from the harm of potentially dangerous nostrums and spared the cost of false elixirs.