FDA regulation of prescription drug advertising

Article Abstract:

The Food and Drug Administration's (FDA) regulation of activities to promote prescription drugs was recently reviewed. It was found that brief summaries of drug effects used in advertising should be revised to be more readable and useful to the general public. In addition, the promotional activities of pharmaceutical companies, such as distribution of gifts to health care providers, should be more extensively monitored by the government. The packaging of prescription drugs includes an insert that provides important information derived from well controlled studies submitted to the FDA by the drug manufacturer. The information in the insert also sets limits to be used by the manufacturer for promotion of the drug. The drug cannot be promoted for conditions that are not indicated in the insert and promotional activities must also indicate the safety considerations contained in the insert. Although the FDA does not want to discourage funding of continuing medical education by drug companies, the agency encourages discussion of research on new products and uses that have not been fully evaluated. Promotion of a drug product may often be difficult to distinguish from provision of scientific information. To help in making a distinction between drug promotion and scientific exchange, the FDA will assess the role of the manufacturer in publicizing preliminary results beyond the research community. Other professional societies, including the World health Organization, have established guidelines for drug promotional activities. In many cases, drug advertisements directed at the consumer, such as advertisements discussing the risks of hypertension, have been beneficial in promoting health. In the future, the FDA will develop guidelines on direct-to-consumer advertising, industry-sponsored continuing education, and press releases. These guidelines will also establish the limits of the FDA's role in decisions about these issues. (Consumer Summary produced by Reliance Medical Information, Inc.)

Standards, Evaluation, Pharmaceutical industry, Advertising, Advertising law, Pharmaceutical ethics

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Regulatory status of pancreatic enzyme preparations

Article Abstract:

An article in the May 9, 1990 issue of The Journal of the American Medical Association reports on the therapeutic failure of a pancreatic enzyme generic drug. The product in question was manufactured by Anabolic, Inc of Irvine, California. The Food and Drug Administration (FDA) inspection revealed a problem with the enteric coating process (designed to allow drug release and absorption in the intestines), and in June 1989 the product was voluntarily withdrawn from the wholesale market, prior to any reports of therapeutic failure. After reports of therapeutic problems in June 1989, a dispensing level recall was implemented. Several points are worthy of further examination. Pancreatic enzyme products have enjoyed a long history of safe use in treating pancreatic function deficiencies, even without being subject to government regulations. Because pancreatic enzyme medications were not packaged with enteric-coated spheres prior to 1938 (the cut-off for being subject to federal regulations), theoretically, those with enteric coating should require FDA approval for marketing. In a panel appointed by the FDA to review a variety of over-the-counter drug products, the active ingredients used in pancreatic enzyme products were evaluated for safety and efficacy. The panel concluded that these drugs were generally safe and effective. However, the FDA panel also pointed out that enteric-coated pancreatic enzyme preparations may be less effective. Additional comments received by the FDA have recommended that pancreatic enzyme products be restricted to prescription use. The matter is still under review by the FDA. (Consumer Summary produced by Reliance Medical Information, Inc.)

Health aspects, Generic drugs, Enteric-coated tablets, Enteric coated tablets, Digestive enzymes

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Understanding consequences of concurrent therapies

Article Abstract:

A nearly fatal case of terfenadine-induced torsades de pointes highlights the importance of drug-drug interactions in the body's metabolism of drugs. Torsades de pointes is a rare form of arrhythmia. Terfenadine is an antihistamine that is normally metabolized rapidly. In this case, a woman simultaneously took terfenadine and the anti-fungal drug ketoconazole. Studies on the interaction of terfenadine and ketoconazole found that ketoconazole impaired the metabolism of terfenadine, allowing excessive concentrations of the parent drug to accumulate. Individual variations in drug metabolism are influenced not only by drug interactions but also by genetics. For example, some individuals have a deficiency of enzymes critical to drug metabolism and may be more prone to adverse drug reactions. Ideally, potential drug-drug interactions would be determined before a drug is marketed and licensed, but physicians and patients should watch for adverse reactions given the individual variability in drug metabolism.

Editorial, Drug interactions, Drug metabolism

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