MARKETING RESEARCH CAN BE DISTINGUISHED FROM PROMOTION BY PHYSICIAN FOCUS GROUP OBJECTIVES, STRATEGIC MARKETING CORP. TELLS FDA AD REGULATORS

Marketing research can be distinguished from sales promotion by examining the objectives of physician focus groups, opinion leader panels, and other marketing research studies, Juliet Zimmerman, president of Strategic Marketing Corp. told FDA in a Sept. 19 presentation to the Division of Drug Marketing, Advertising and Communication. Several "clues" exist for distinguishing whether the only objective of a study is marketing research or if a disguised promotional campaign is taking place, Zimmerman told the FDAers, according to outline slides prepared for the meeting. Stressing that "research must be the only objective of bona fide marketing research," Zimmerman said that compliance with Council of American Survey Research Organizations (CASRO) standards is an important earmark of legitimate research. Zimmerman said research objectives should be "clearly stated and understood by" both the marketer and the respondent, and a study should have "sponsorship by a firm's marketing research department," although she acknowledged that "deceptive organization structures exist." Zimmerman noted that participant anonymity is another important aspect to legitimate marketing research studies; studies aimed at promotion, she said, often follow up on participants or track physician prescribing habits. Formulating guidelines for appropriately conducting marketing research "will be difficult but possible," Zimmerman predicted. While noting that the number of participants in a marketing research study generally "is very small," Zimmerman added a caveat to using sample fraction as a standard for judging a study's legitimacy. She warned that "the number of subjects ...is not always a key to differentiating sales from" marketing research or CME. She pointed out that a legitimate study can include anywhere from 10 to 1,000 respondents. Zimmerman expressed similar reservations about the use of size of honoraria as a "litmus test" for differentiating marketing research from promotion, noting that the amounts of remuneration she regarded as potentially acceptable vary widely. Another problematic potential guideline is the medium of studies, which, like sales promotion, take place through the mail, on the phone and in person. She also said the location of studies, which take place in hotels, hospitals, physicians' offices, conventions, and specialized facilities, cannot be used to distinguish research from promotion. The difference between bona fide marketing research and promotion, Zimmerman said, has been "muddied." Marketing research techniques "were seen to lend themselves to promotion," she said, noting how physician focus groups can easily be confused with peer influence groups, telephone surveys with telemarketing, and opinion leader panels with symposia. Current AMA guidelines allow physicians to receive honoraria for marketing research programs but not for company-sponsored CME programs or medical symposia. Zimmerman said that marketing researchers have traditionally employed honoraria to "induce participation" in studies, to compensate participants "for time and knowledge," and to "say thank you." She pointed out that marketing research honoraria generally range from $ 25 to $ 150 but can go as high as $ 2,000. The Health Research Group recently called FDA's attention to SmithKline Beecham's use of focus groups, which paid honoraria, on two products pending at FDA -- the NSAID Relafen (nabumetone) and the antidepressant Aropax (paroxetine). In a Sept. 5 letter to FDA, HRG Director Sidney Wolfe, MD, called the meetings "illegal" and "unethical" ("The Pink Sheet" Sept. 9, T&G-3). Wolfe said he received a response to the letter from FDA Commissioner Kessler on Oct. 24 saying the agency is looking into HRG's charges.