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Executive Summary

DRUG ADVERTISING "READABILITY" ISSUES IN SPOTLIGHT AT FDA in reaction to the agency's perception that current promotions are not always providing side-effect information and contraindications "clearly and prominently," Division of Drug Marketing, Advertising and Communications Acting Director Janet Rose reported at a May 19 meeting i Washington, D.C. Addressing a Food & Drug Law Institute "Pharmaceutical Update" conference, Rose maintaine that one problem that is "continuing to appear" is the readability issue. "In fact," she said, "we'v actually...become aware of several incidences where this readability issue is particularly troubling." Disclosure of side effects and contraindications of drugs in broadcast media is an area where the industry "has not routinely complied" with the regs, Rose contended. This information should be included in "the audio or audio and visual parts of the presentation." Rose added that "a less adequate provision" is made for disclosing side effect information and contraindications by disseminating "the approved or permitted package labeling in connection with the broadcast." The agency has been working on a policy statement covering broadcast media. Rose also questioned current compliance trends with the requirement that promotional materials be submitted to the agency at the time of initial dissemination or publication. Rose observed that there are "recent indications" that companies "may not be full complying" with those regulations. In the area of industry-sponsored continuing medical educational programs, FDA is looking at the acceptability of pre- packaged program proposals. Rose noted that the issue was raised by a letter to the agency which asks what should b done "when a pharmaceutical company is presented with a complete agenda in conjunction with a request to sponsor a CME program." "Detailed proposals are inconsistent with our draft policy statement," Ros observed. She invited firms to send in comments on the issue and said FDA wants further dialogue on this issue. Until a policy is developed, Rose suggested that companies refrain from supporting such programs. As for CME programs in general, FDA hopes to "issue a final polic statement shortly," Rose said. A draft CME policy statement issued in November ("The Pink Sheet Nov. 30, 1992, p. 13). U.S. Bioscience says that it is diverting a portion of its medical conference exhibit budget to grants to cancer centers. The cancer therapeutics company announced that "funds that would otherwise be used to distribute promotional items at medical conferences wil not be redirected as donations to cancer centers in the conference locales." The funds will go towards supporting "unmet needs in the comprehensive management of patients with cancer." The company gave its first grant to the Orlando Cancer Center in conjunction with the meeting of the American Society of Clinical Oncologists and the Oncology Nursing Society. The grant will help develop techniques to assist children in coping with difficulties learning and remembering that can follow cancer treatment.

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