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FDA’s AD DIVISION IS ASSESSING UCLA JOURNAL AD STUDY METHODOLOGY

Executive Summary

FDA's AD DIVISION IS ASSESSING UCLA JOURNAL AD STUDY METHODOLOGY with the intention of developing appropriate methodology for FDA reviewers to conduct similar studies, Office of Drug Standards Acting Director James Morrison told a Sept. 14 Food & Drug Law Institute meeting. The studies may serve as the basis of an evaluation tool that the division would use to review print ads for prescription drug products, the FDAer noted. Morrison provided FDA's perspective on the peer review study of prescription drug ads, which found, on average, 4.3 potential violations of FDA regulations per ad ("The Pink Sheet" June 1, p. 3). "My intent today is not to critique the study nor to castigate the industry or defend the FDA," he noted. "Instead, I would like to discuss some fundamental issues raised" by the study, conducted at the UCLA School of Medicine under the sponsorship of the HHS Inspector General. FDA is "analyzing in depth the data upon which the IG report was based in order to learn qualitatively about how the experts evaluated different types of ads," Morrison said. The Division of Drug Marketing, Advertising and Communication said it is looking at all the ads involved in the UCLA study to determine what actions the agency would have taken. The UCLA study recruited 108 physicians and 53 pharmacists to review 109 ads appearing in 1990 issues of 10 medical journals. "We are looking at ways to do a parallel kind of study in- house, but using only FDA criteria, not any educational value," Morrison explained. Stressing the preliminary nature of FDA's look-see, he added: "These are purely exploratory-type studies to see if there is some value in our own staff looking at drug ads periodically and doing systematic assessment of a sampled group of ads than what we do normally, which is surveillance of the marketplace as a whole." Periodic agency staff reviews of ads "could provide a means of tracking the effectiveness of the advertising division and of our enforcement strategies" and "could determine trends in compliance from year to year," Morrison pointed out. The agency will also determine "how best to expand the study universe to include promotional materials besides print ads," Morrison said. FDA has conducted two focus groups with physicians to examine perceptions about drug labeling information. The studies, conducted by National Biosystems, Inc., are part of FDA's attempt to make professional labeling more useful ("The Pink Sheet" July 27, T&G-9). The discussions formed the basis of a potential survey to cover telephone interviews with about 400 physicians. The survey will ask physicians how they use labeling, what information they look for and how they think labeling can be improved. The focus groups -- a panel of nine primary care physicians and a panel of nine specialists -- were provided samples of package inserts. The focus group report, completed in February, states: "There seemed to be a general feeling that there is too much detail about warnings or side effects for which there is actually only a minimal risk." One concern of primary care physicians was that "there is so much information that it is difficult to find what you really want," the report notes. Specialists' concerns included: "too much information, much of it not useful" and "not 'user friendly'." The focus groups also were shown ads along with brief summaries. Comments on the brief summaries included: "I would almost never consult this; maybe for a totally new drug; [maybe] if a patient has complained; [or the physician was] totally bored, or I had new glasses." Other comments were: "The print is too small" and; "Given the availability of the package insert, why is the brief summary necessary." The physicians thought that while ads inform the existence of new products they are also "not useful" and "of dubious credibility," the report says. FDA also plans to contract for a study of physician perceptions of particular ads. The division would use the results to see whether the physicians' views correlate with those of the division reviewers.
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