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Executive Summary

FDA ADVERTISING ABUSES "HOTLINE" EXPECTED TO BE UP BY SEPTEMBER with a toll free telephone number that health care professionals can call with complaints and/or questions about information provided by health care products manufacturers. An FDA background paper said that the agency's "Medical Advertising Information Line" will be open for calls regarding promotions of drugs, biologics, medical devices and veterinary drugs. FDA plans to advertise the hotline in medical, nursing and pharmacy journals. The hotline will be managed by the Medicine Staff in FDA's Office of Health Affairs. FDA was originally thinking of setting up the information line within the Division of Marketing, Advertising and Communications to deal with drug promotions. A consumer safety officer from that division, David Banks, announced plans to set up the hotline at the Ohio State University's annual pharmaceutical seminar in April ("The Pink Sheet" April 29, p. 3). However, Commissioner Kessler reportedly liked the idea of the information hotline so much that he decided that it should handle advertising issues that involve all of FDA's Centers. The Office of Health Affairs' Medicine Staff was selected to take responsibility for the hotline because its main function is to act as liaison between FDA and health professionals. FDA considers the hotline a pilot project, which will be evaluated six months into the program. FDA intends to recruit two full-time professionals to manage the information lines. They will report to Peter Rheinstein, MD, head of the Medicine Staff, and Thomas McGinnis, associate director for pharmacy affairs. The agency plans to establish two "800" phone lines to handle the calls. "One line would be answered live during business hours, the second would be a rollover line to be answered by a machine when the first is busy," the backgrounder notes. The second line will also serve as a FAX, allowing professionals to send promotional materials free of charge. FDA anticipates that the telephone charges for the two lines will cost about $ 800 a month. The backgrounder also outlines FDA's thinking on how it will handle calls on the hotline. "Working with appropriate Center representatives, OHA could design a form which would be completed, possibly using a computer, by the person answering the phone," the sheet says. "The form could then be used for statistical purposes and, by FAXing it to the appropriate Center, as background information for making a return call to the reporter. Some calls would be transferred directly to an appropriate office for follow up." FDA pointed out that "procedures will need to be developed for referring or transferring calls to the Centers and to assure uniform follow up on reports that are forwarded to the Centers." In addition, the backgrounder notes, "a uniform procedure on the 'close-out' of reports also needs to be developed."

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