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Executive Summary

The Bristol-Myers Oncology Division will begin sending "Dear Doctor" letters to the 8,000 previous recipients of the controlled circulation publication "Oncology Commentary '90" during the week of June 3-7 as part of a settlement with FDA over alleged promotions of unapproved cancer indications. The letters will disclose that the publication and some of the meetings referred to in the publication were sponsored by Bristol- Myers and will inform doctors "that only favorable opinions and data" on Bristol-Myers Squibb products were selected for inclusion in the publication. FDA further wants the company to tell doctors that, in the context of a promotional publication, "Oncology Commentary" did not contain sufficient detail "to permit informed evaluation." FDA and Bristol-Myers Oncology have agreed that the company will assure delivery of the letters to all physicians who received the magazine. FDA specifies that the "letter must be delivered into the hands of the physician." The company has offered to use its detail force to deliver as many of the corrective letters as possible. The "Dear Doctor" letter is one element of a two-part corrective action extracted by FDA. In addition to the "Dear Doctor" letter, the "settlement" will entail a two-year commitment from the company to submit the majority of its promotional material for oncology products to FDA for preapproval (see related story, p. 6). While the format of the settlement is not unusual in the context of recent drug advertising actions by FDA, the public relations treatment of the event and some of the details of the program are evidence of the agency's effort to portray a stronger enforcement image to the public. There is speculation in Washington that the publicity may be a warm-up event for further (and potentially more forceful) drug promotion regulatory actions in upcoming weeks (see related story, p. 3). The Bristol-Myers incident is most notable for the extent and timing of the media coverage that it generated. FDA is traditionally scrupulous about trying to avoid general publicity for a "Dear Doctor" letter until the medical community has received the letter. In the Bristol-Myers situation, the inverse occurred. FDA began discussing the corrective action with the media at least one week before the company was ready to send out the letter. The preemptive release of information to a wide audience prior to the conclusion of the normal course of regulatory events is similar to the agency's handling of a regulatory situation at Lilly almost two years ago. In that case, FDA released information about an adverse inspection at Lilly to indicate the forcefulness and breadth of the agency's inspection program and to try to fend off criticism of lax enforcement procedures. The agency released information about Lilly as a plant inspection was ending and before the company had the opportunity to respond to the inspection observations ("The Pink Sheet" Aug. 28, 1989, p. 13). The early publicity in the Bristol-Myers situation presumably furthers two objectives of the top managers at FDA: (1) it helps to reestablish the agency's public posture as a forceful regulator of promotions; and (2) it sends a warning to companies about protracting negotiations with the agency. The FDA-Bristol negotiations took over 10 months. One irritant to FDA in the Bristol situation may have been the delay of the "Dear Doctor" letter until after the recent annual meeting of the American Society of Clinical Oncology (ASCO). Earlier in the negotiations, the company was supposed to distribute the letter to that group. As the company and agency neared an agreement last month, Bristol-Myers objected to FDA's request to run corrective advertisements in addition to the "Dear Doctor" letter. The company was successful in getting FDA to back off the corrective ad demand. FDA may have countered that by using the media; but the agency was likely to try to get coverage for its enforcement action against Bristol regardless of whether the firm agreed to an ad. The company objected to the corrective advertisement because it would carry the message to an audience larger than the one that received the original publication. Bristol questioned the rationale for a corrective ad in general medical journals such as The New England Journal of Medicine because the original offending publication had been distributed to a defined group of oncologists and hematologists. The company felt it could reach that group directly with a "Dear Doctor" letter. Bristol maintains that it works hard to limit promotions in the oncology area to those doctors trained to administer anti- cancer drugs. The firm believed that a general corrective ad would run counter to that policy. FDA apparently pushed for the corrective ads as a form of educational punishment. A letter to the oncology specialty alone may not have been strong enough from FDA's point of view. Within the oncology specialty, a "Dear Doctor" letter on unapproved indications from the leading company in the field is not likely to have very much impact. Much of the drug use in that area is off- label already, and the specialists in that field are used to trying to keep up with the latest clinical applications of approved and experimental products. The publication that elicited FDA's ire was a sole-sponsored magazine with information on current oncology clinical practice and summaries of reports from medical meetings. FDA initially questioned Bristol-Myers Oncology's sponsorship of the publication in August of 1990, and the company ceased funding of the project at that point. The firm's discontinuation of the publication last summer, however, was not enough to satisfy FDA, which aggressively has pursued the more public mea culpa from the firm during the last 10 months. In January of this year, the agency issued a sharp rebuke to the firm for the alleged promotion of unapproved uses in the publication ("The Pink Sheet" Feb. 11, p. 12). The agency and the firm have been involved in protracted discussions of corrective actions during the four months since the January letter. In a May 17 letter to Bristol-Myers Oncology Division General Manager John O'Leary, FDA's top advertising and promotion regulator, Ann Witt, described "Oncology Commentary" as "a publication which we determined to be promotional literature in the guise of a scientific journal." Bristol says its "stands behind" the the validity of the science in "Oncology Commentary." Bristol maintains that it responded to FDA in a timely manner throughout the discussions. The company claims that, after it responded to FDA's initial concerns about the ad in August of last year, it did not hear back from the agency until the January rebuke. For Bristol, the publicity over the dispute with FDA comes at a difficult time. The company appears to be on the verge of getting a potentially important AIDS treatment (Videx, ddI) approved later this summer and it is just preparing to bring its second ACE inhibitor, Monopril, to the market ("The Pink Sheet" May 20, T&G-1). After the Videx approval, the firm will face the ticklish challenge of shifting roughly 19,000 patients receiving the drug under expanded IND provisions to paying patients. The pricing issues in AIDS treatments have been tough going for the drug industry from the start. If the aggressive-promoter image from the oncology dispute sticks in the media's collective memory, Bristol may face a particularly tough task to convince the lay press about its pricing decisions for Videx. Similarly, a spillover effect within FDA's ad division from the oncology discussions could restrict Bristol's ability to try to find a place for Monopril in the ACE market. The company may be subjected to heightened scrutiny of its initial campaigns for the Captopril followup.

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