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Executive Summary

BRISTOL-MYERS SQUIBB's DISTRIBUTION OF MEDICAL TEXTBOOK EXCERPTS WILL BE DISCUSSED at a meeting between FDA and textbook publisher J.B. Lippincott on July 15. Lippincott representatives will meet with officials from FDA's Office of the Commissioner and the Division of Marketing, Advertising and Communications to discuss the agency's policy on distribution of textbooks by pharmaceutical companies and specifically whether Bristol-Myers Squibb salespeople may distribute excerpts from an oncology textbook describing unapproved uses of the company's cancer therapies. Bristol-Myers Squibb was notified by the marketing division in March that it would not receive clearance from the agency for its plan to distribute "Selected Readings from Principles & Practices of Oncology" by Vincent DeVita, MD, Samuel Hellman, MD, and Steven Rosenberg, MD, National Cancer Institute. The chapters involve discussions of lung cancer, surgery, radiation therapy, chemotherapy and pulmonary complications of cancer. In a March 23 letter to BMS, FDA said: "At this time, the above item is considered unacceptable [because] the excerpted textbook contains chapters which discuss unapproved indications of Bristol-Myers Squibb oncology products." The agency added, however, that "the entire unaltered textbook could possibly be distributed as a 'service' of BMS, assuming that discussions of uses of BMS drugs do not constitute a major portion of the book." Under an agreement signed in May 1991, Bristol-Myers Squibb must preclear with FDA all promotional materials relating to oncology products ("The Pink Sheet" June 3, 1991, p. 4). The agency mandated the two-year probationary period because of repeated violations of FDA's policy against promoting unapproved uses. FDA and the company came to a compromise on the distribution of the entire textbook before the annual meeting of the American Society of Clinical Oncology. BMS had intended to display and distribute the book at its exhibition booth. Instead, BMS representatives displayed a picture of the textbook and took orders for the book from physicians. FDA found this acceptable because the textbook was then distributed by a third party, ASCO. Meanwhile, Lippincott President Alan Edelson, PhD, wrote the agency in May to protest FDA's disallowance of BMS' plan to distribute excerpts of the textbook. The publisher explained that "Bristol's intent was to distribute the material to pulmonologists, a narrow market for the book, which sells primarily to oncologists." Edelson maintained that "if such a specialist were to buy, and chances are that at $180 they would not, it is most likely that they would not read the book cover to cover but turn to the chapters dealing with their areas of expertise." The Lippincott publisher argued that its publications are truly independent, not "misnamed 'independent' publications that have actually been funded by the pharmaceutical industry." Edelson continued that FDA "has mentioned that it will not impede the distribution and exchange of rigorous and balanced scientific information, yet continue[s] to rule against such exchange. [FDA] say[s] that textbooks are acceptable, then [it] say[s] they are not." According to Lippincott, publishers have begun to feel the effects of FDA's crackdown on promotions and educational materials. The company said that Merck declined to fund and distribute a supplement on benign prostatic hyperplasia last autumn because of FDA's heightened enforcement of promotion of unapproved uses. Merck's BPH drug Proscar was not approved at the time. In another case, Squibb Diagnostics bought 4,000 copies of a textbook on magnetic resonance imaging but did not distribute it, Lippincott said.

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