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ONCOLOGY PROMOTION GUIDELINES FROM FDA SOUGHT BY BRISTOL-MYERS SQUIBB

Executive Summary

ONCOLOGY PROMOTION GUIDELINES FROM FDA SOUGHT BY BRISTOL-MYERS SQUIBB as an outgrowth of the company's recent set-to with the agency over promotional materials for unapproved uses of cancer drugs. During the regulatory back-and-forth leading up to the issuance of a June 4 "Dear Doctor" letter, Bristol repeatedly urged FDA to address the distinction between educational materials and promotions in the oncology field. In a May 10 letter to Ann Witt, acting head of FDA's drug marketing, advertising and communications division, Bristol asked for discussions on a guideline to "recognize the special role that company-distributed educational material plays in the optimal treatment of cancer." FDA guidelines, the company argued, would "provide some degree of certainty regarding our compliance with FDA requirements as we develop our promotional and scientific materials." In an earlier letter during the correspondence, Bristol-Myers Oncology Division General Manager John O'Leary maintained that the company "has tried to balance the need for scientific information with FDA's prohibition against off-label promotion of oncology products." O'Leary observed that the distinction is "difficult in oncology where, as a recent GAO study revealed, many uses are off- label, and 69.4% of oncologists and hematologists rely on company- sponsored scientific information to learn about new treatments." Bristol has indicated that it intends to pursue the issue of oncology promotion guidelines following the resolution of the current debate with FDA. If the firm is successful in engaging FDA in a discussion of off-label promotions in the oncology field, it could have a spillover impact on information exchange practices on other off-label and investigational uses. FDA has said that the agency is interested in Bristol's ideas for an appropriate forum for discussing oncology promotion guidelines. Bristol apparently concluded a two-year dispute with the agency on June 4 by sending "Dear Doctor" letters to 8,000 oncologists and hematologists. The letters were written to inform the medical community that the agency believes that a sole- sponsored publication "Oncology Commentary '90" was a "promotional publication in the guise of a scientific journal." The resolution of that issue ends what FDA characterized as a pattern of violative promotional activities ("The Pink Sheet" June 3, p. 4). While the firm is pressing FDA for further guidance on oncology promotions, the agency has made a first effort at that subject within the last three years. In a Feb. 13, 1989 letter from FDA's William Purvis, the drug advertising division broadly delineated "permitted" and "non-permitted" promotions (see box at left). The 1989 letter related to a "monograph-like booklet" on the use of VePesid in the treatment of small-cell lung cancer. FDA criticized the monograph for promoting an approved use of VePesid with two other products that were not labeled for that indication. Bristol continues to dispute FDA's view of that promotion, claiming that it shows how a strict adherence to labeling can interfere with established oncology treatment regimens. Bristol "voluntarily withdrew" the VePesid monograph but has continued to defend it as "a full description of a study on the use of VePesid for small cell lung cancer, in combination with two other drugs." The company notes that VePesid labeling permits the combo use for that indication but "the labeling of [the two other] drugs had never been changed to reflect their use with VePesid." The company contends that "it seemed" in 1989, "and it still seems now, illogical to prohibit promotion of VePesid for an approved use in an approved combination because the other drugs did not have their labels changed." CANCER DRUG PROMOTIONS: PERMITTED/NOT PERMITTED LIST Excerpted from a Feb. 13, 1989 letter from FDA's drug ad division to the Bristol-Myers Oncology Division. To prevent any future misunderstanding regarding our position on advertising oncology drugs and their uses, the following with analogous examples should clearly outline our policy: 1) Permitted: a) As you know, a prescription drug may be advertised or promoted for one or all of its approved indications (e.g. Cytoxan for leukemia); b) You may also advertise or promote a drug for use with other drugs when the approved labeling provides for this (e.g. thiazide diuretics with other antihypertensives); c) It may be promoted or advertised for use with other agents when all products are approved for use in treating the same condition (e.g. concomitant use of Brethine -- bronchodilator with theophylline -- also a bronchodilator). 2) Not Permitted: a) A prescription drug may not be advertised or promoted for any use not approved in the indication section (e.g. oral contraceptives to treat acne, CeeNU, Cytoxan or BiCNU for small cell lung cancer); b) A product may not be advertised or promoted for use in combination with other chemotherapeutic agents when the other agents are not approved for use in the particular circumstances (e.g. CeeNU, BiCNU or Cytoxan with each other to treat small cell lung cancer).
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