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Executive Summary

FDA is concerned about the use of pharmaceutical sales forces to announce educational programs held by academic and medical centers. The agency apparently considers the announcement of seminars as a promotional door-opener for sales representatives. As part of the agency's on-going discussions with Bristol- Myers Squibb over that company's extensive participation in oncology continuing education, the agency has indicated that if an academic or medical institution allows the BMS sales force to announce upcoming seminars, then FDA will consider those seminars as corporate promotional events. The de facto restrictions on the use of the sales force in conjunction with medical seminars were outlined by FDA in a letter to the company in late July. The company has been meeting with FDA for the past three months in the wake of a settlement agreement reached in early June. A primary feature of that agreement is a two-year commitment by BMS to preclear any future promotional materials in the oncology area with FDA ("The Pink Sheet" June 3, p. 4). BMS has been trying to elicit from FDA a clearer statement of what activities are viewed as promotional by the agency -- and thus require preclearance. While the nature of the BMS/FDA discussions are colored by FDA's unusual authority under the existing agreement, the BMS experience is instructive of FDA's concerns about crossing the line between promotion and scientific interchange in the sponsorship of symposia and other forms of medical education. BMS may sponsor continuing medical education seminars without preclearing them with FDA if the firm meets three conditions: (1) the company agrees to keep FDA informed about seminar activities funded with its money; (2) the company can assure FDA that the speakers and sponsoring institution fully disclose all affiliations in the seminar brochures; and (3) the company does not use its sales force to help announce upcoming seminars. The company is willing to notify FDA of the seminars sponsored under its funding and is suggesting a quarterly reporting schedule to consolidate the paperwork. However, BMS objects to FDA's attempt to have the firm serve as a policeman over potential conflicts-of-interest by assuring full disclosure of affiliations. BMS argues that it cannot require that all affiliations be printed in a seminar program because it does not control the design or printing of brochures. The company notes that it determines which institutions will receive grants, but, once the grant decision is made, BMS takes a hands-off policy towards the development of the program. According to the procedures to protect the independence of the symposium production, BMS says it cannot assure what the symposium program will say. In response to an FDA request, however, the company will attempt to make sure that its name as sponsor appears prominently on the cover of conference materials. The company is worried about implicit questions into the ethics and integrity of speakers at the seminars. If the company is required to try to force institutions to reveal the affiliations of speakers, BMS believes it could be effectively prevented from sponsoring seminars. The full disclosure issue also has been raised by FDA in relation to the sponsorship of controlled circulation publications. BMS sponsors a publication called "Advances in Oncology," which the firm says is editorially controlled by a separate board outside the control of the company. FDA wants the full list of affiliations for the editorial board, the authors and the institutions mentioned in the publication to be disclosed. If they are not, FDA will consider the publications promotional and will want to see copies for preclearance. The agency also believes that only peer-reviewed articles from referred journals should be cited as references by articles in "Advances in Oncology." Any article on a Bristol product in a magazine solely sponsored by Bristol may be viewed as labeling, FDA warns. BMS has gotten FDA to relent on some of its views of promotional material in the oncology area. For example, the agency said that the company can sponsor a book of independently-prepared abstracts from the annual meeting of the American Society for Clinical Oncology. The abstract book will not have to be precleared with the agency. Similarly, textbook supplements to Principles and Practices of Oncology can be sponsored by BMS without preclearance, FDA has informed the company. However, if the textbook supplement contains an advertisement for a BMS product, FDA wants to see the supplement as well as the ad. That would appear to put BMS in the awkward position of having to try to get a prepublication copy of the supplement from the independent textbook publishing firm to submit to FDA.

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