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Executive Summary

FDA STUDYING LABELING's SUCCESS IN COMMUNICATING SAFETY INFORMATION TO MDs, Division of Drug Marketing, Advertising and Communications Acting Director Cheryl Graham, MD, told a July 20 Drug Information Association workshop. The division's drug advertising group has "several studies under way in which we are trying to identify usable communication formats for physicians," Graham said. She pointed out that there have been "no recent studies done about the ability of the package insert to communicate information to physicians, the primary target audience." The agency hopes the studies will provide insight on how the package insert can become "a more useful document," Graham said. FDA is "convinced that those studies will enlighten us enough that we will begin to be able to make some recommendations [as] to how to change both the type, the quality, the messages, the wording [and] the display of the information in the package insert." The project officer for the studies is Nancy Ostrove, PhD, a public health analyst. The project includes two focus groups and three quantitative studies, one involving a survey of physicians, Ostrove said. National Biosystems, Inc., a scientific research firm in Rockville, Md., is conducting the studies under a $250,000 contract. The two focus groups, comprising nine physicians each, already have met. The groups' discussions enabled researchers to put together a survey that, if cleared by the Office of Management and Budget, will be used in telephone interviews of approximately 400 physicians. The survey asks physicians how they use package inserts and brief summaries, what information they look for when prescribing and how they think labeling can be improved. The design of the other two quantitative studies has not been finalized, Ostrove said, but it may involve presenting physicians with current package inserts and brief summaries and possible alternatives for those documents. The physicians may be asked which labeling formats they think effectively communicate information and which formats they prefer. The project's advisory group includes representatives from the Pharmaceutical Manufacturers Association, the American Medical Association and the U.S. Pharmacopeia. FDA is also involved in a joint study with the Federal Trade Commission to evaluate consumer perceptions of advertising and labeling of OTC drugs. Market Facts, a Washington, D.C. research firm, is conducting the study ("The Pink Sheet" March 23, T&G-11). Graham said that the drug advertising staff and the NDA reviewing staff, in going over warnings, precautions, and highlighted safety information in labeling, "have noted a lot of problems about which important information really needs to be highlighted in the labeling and what the justification is for moving it from one position to another." Referring to recent labeling changes for all ACE inhibitors and Marion Merrell Dow's Seldane, Graham noted that "in both of these cases the important safety information had been present in the approved labeling for the product for some time." The FDAer pointed out that the pregnancy information in the labeling of ACE inhibitors was in the adverse reactions section. Cases of fetal harm resulted in class-wide labeling changes in March including a boxed warning cautioning against use in pregnancy ("The Pink Sheet" March 16, T&G-3). Graham noted that the warning about the use of Seldane with the antifungal ketoconazole (Janssen's Nizoral) had been in the label's precautions section. Because of accumulating rare cases of cardiovascular adverse events, Seldane labeling will carry a new boxed warning contraindicating its use with ketoconazole and with the antibiotic erythromycin ("The Pink Sheet" July 13, p. 9). The FDAer said that "partially because of the placement in the labeling, no...emphasis on the information was provided in the promotional...materials for [Seldane]." She added that what "we need to think about continuously is reinforcing and reinstructing" physicians about "important safety aspects and limitations" of products. Label changes about safety issues "probably require an entire communication plan to make sure that at the very least all physicians become aware of the new information."

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