BRISTOL's "ONCOLOGY COMMENTARY '90" IS PROMOTIONAL VEHICLE FOR UNAPPROVED INDICATIONS, FDA ALLEGES IN SHARP REBUKE TO FIRM FOR CONTINUING VIOLATIONS

"Oncology Commentary '90," a sole-sponsored publication produced for Bristol-Myers Squibb by L.P. Communications, crosses the line between education and promotion because of a lack of balance and unsupported claims of superiority for BMS products, FDA told the company in a sharply worded Jan. 25 letter. The publication promotes unapproved uses of BMS products "rather than providing a scientific discussion focusing upon experimental methodology and data," FDA alleges. In addition, the publication claims Bristol-Myers Squibb's products "to be superior to competing products in the absence of data presentations establishing such superiority." The agency contended that BMS "engaged a commercial firm to act as a surrogate marketing entity on [its] behalf, while wrapping this misleading commercial activity in a facade of science and education." Bristol-Myers Squibb "should be aware by now that promotional activities cannot escape the requirements of the Act merely because they do not involve direct participation of [the firm's] sales representatives or marketing staff," FDA told the company. FDA called the materials "clearly deficient in terms of objectivity, balance, scientific rigor, and regulatory/legal compliance." The publication constitutes "a misleading promotional activity couched as an educational discussion of unapproved uses," FDA asserted. Unapproved indications discussed in the publications include: non-small cell lung, bladder, head and neck cancers for Paraplatin; non-small cell, gastric, metastatic breast, non- Hodgkins lymphoma, and acute myelogenous leukemia for VePesid; non-small and small cell lung, gastric, and metastatic breast cancers for Platinol; and cachexia associated with cancer or AIDS and metastatic prostrate cancer for Megace. "Although current oncologic practice may often involve administration of drugs for unapproved uses," FDA said, a firm "cannot under law, promote these unapproved uses or otherwise engage in activities misbranding those products under the Act." Such promotional activities are "especially troubling," FDA maintained, because "they may encourage physicians without extensive oncologic experience to administer these potentially toxic products for these unapproved uses on the basis of [the company's] claims and suggestions that they are safer." "The scientific, regulatory, and legal standards serving as the basis for our regulatory action in this case have been enunciated clearly, specifically, and repeated to your firm and the industry at large," FDA asserted. "There may be limited discussions of unapproved uses in scientific or educational activities sponsored by a firm, provided that the activities are objective, balanced and scientifically rigorous," the agency said. FDA was particularly severe in its chastisement of BMS for two apparent reasons: (1) the repeated nature of the promotions; and (2) the agency's sensitivity to Capitol Hill oversight of its promotional enforcement activities ("The Pink Sheet" Dec. 17, p. 3). The company "has engaged in promotion of unapproved uses of [its] products, during an extended period of time and over [FDA's] specific objections," FDA Drug Advertising and Labeling Acting Director Ken Feather declared, in the letter. Feather cited a letter sent to the company in September 1988 concerning a brochure that discussed the use of VePesid for unapproved combination chemotherapy. In November 1989, however, FDA requested that Bristol-Myers Squibb stop distribution of an audio tape on carboplatin and cisplatin disseminated by New York-based L.P. Communications. FDA reprimanded the company for having "acceded to [FDA's] demands for discontinuance of specific violative activities, as well as all similar activities, and then proceed[ing] with essentially the same activities without further consultation with the agency." The dissemination of the new materials "is clearly inconsistent with [Bristol-Myers Squibb's] prior commitment to discontinue such activities," the agency contended.