SMITHKLINE FOCUS GROUPS: FDA "CANNOT CONCLUDE" AD REG VIOLATIONS

SMITHKLINE FOCUS GROUPS: FDA "CANNOT CONCLUDE" AD REG VIOLATIONS occurred with SmithKline Beecham sponsorship of market research discussion groups, FDA Division of Drug Marketing, Advertising and Communications Acting Director Cheryl Graham, MD, said in a Nov. 3 letter to the company. Graham stated that "given the information currently available, we cannot conclude that the activities violated the advertising regulations of the Federal Food, Drug, and Cosmetic Act." FDA investigated SmithKline Beecham market research activities for Relafen and Paxil in response to a September 1991 allegation by Health Research Group Director Sidney Wolfe, MD, that the market research groups were being used to promote unapproved drugs ("The Pink Sheet" Sept. 9, 1991, T&G-3). The now-marketed nonsteroidal anti-inflammatory Relafen (nabumetone) was not approved at the time of the complaint. The still pending antidepressant Paxil (paroxetine) was recommended for approval on Oct. 5 by an FDA advisory committee ("The Pink Sheet" Oct. 12, p. 11). In response to Wolfe's charges, SmithKline stated that the discussions were market research meetings intended to get "information from physicians on how best to meet their needs and the needs of their patients." Graham explained that the agency's decision to end the investigation was based on the fact that "there are no FDA or industry guidelines for qualitative marketing research, including focus group research, that could serve as a standard for evaluating whether such activities, conducted by or on behalf of pharmaceutical manufacturers, are promotional rather than accepted means for information solicitaiton activities." In its investigation, FDA "examined a series of activities for nabumetone and paroxetine that were either sponsored, or directly conducted by SmithKline Beecham," Graham said. "This included a close inspection of the use of group meetings (focus groups) where physicians reviewed draft advertising materials." The FDAer added that "some of the research activities appeared to be highly focused on obtaining specific feedback from the physicians. Others, especially the group meetings, appeared to be less rigorously structured." Graham noted that "the number of group meetings held, and the venues in which they were conducted, were not completely consistent with market research practices, as reported to us by marketing research experts surveyed in the course of the inquiry. Thus, these meetings could give the appearance of being other than information solicitation activities." The FDA official pointed out that "the issues raised by this inquiry clearly illustrate the need for well delineated standards in this area." Such standards "would guide both manufacturers and the agency in determining acceptable parameters within which marketing research activities could be conducted." Therefore, FDA encourages "pharmaceutical manufacturers and other interested parties (e.g., the Pharmaceutical Marketing Research Group) to develop a set of standards for qualitative marketing research in the industry." The Pharmaceutical Marketing Research Group is a professional organization for marketing research specialists in drug companies. She added that the agency "would be pleased to participate in this process." Some standards should call for "the objectives of the research, including an appropriate repudiation of any promotional objectives," Graham said. Market research standards should also discuss "the acceptable number of data collections (e.g., focus group meetings or in-depth interviews), and the number of participants per group (in the case of focus groups); acceptable venues for data collection; [and] appropriate inducements/rewards for participation." Industry standards should include the "required qualifications of the researcher (the focus group moderator or interviewer); guidelines for ensuring collection and disposal of stimulus materials used to elicit participant opinions; [and] the kind and level of detail of documentation to be kept regarding the research effort's goals, design, screening parameters, moderator/interviewer guide, and any other relevant aspects of the endeavor."