CONTINUING MEDICAL EDUCATION PROGRAMS DISCUSSING UNAPPROVED USES OF DRUGS WILL NOT BE BARRED BY FDA IF THEY MEET CERTAIN CRITERIA -- FDA SYMPOSIA POLICY

Scientific exchanges on unapproved uses of drugs will not be prohibited by FDA if the discussions meet certain criteria, FDA Division of Drug Marketing, Advertising and Communications Acting Director Ann Witt told an Oct. 8-10 conference on continuing medical education programs hosted by the American Medical Association in Chicago. "I frequently hear fears that FDA is going to somehow prohibit discussions of unapproved uses in activities that drug companies sponsor, whether or not FDA regards them as promotional activities or independent activities," Witt said. "That is not the case." FDA will allow discussions of a drug's unapproved uses when "at least two things [are] agreed upon," Witt noted. "First of all, when unapproved uses are discussed, the fact that the uses are unapproved by FDA should be disclosed to the audience. Second, those discussions should be particularly rigorous." FDA had been expected to release its "draft concept paper" on medical symposia in time to receive feedback on the document from the AMA conference. "I had hoped that I would have had that draft available today," Witt said. "I don't." She blamed the delay on "the workings of a very large bureaucracy" and said that the paper would be available for comment "in the very near future." Nevertheless, Witt discussed several of the key points in the draft concept paper, which will outline FDA's position on how industry and CME program providers can differentiate scientific/educational programs from promotional activities. Witt said that the draft of the guideline will reflect FDA Commissioner Kessler's four basic principles for medical educational activities: balance, objectivity, independence, and scientific rigor. The discussion of educational programs on unapproved uses will be addressed under the category of "balance and objectivity." FDA's draft document on symposia, Witt said, will spell out the agency's desire to see drug firms and CME providers sign agreements to ensure an arm's length relationship by requiring that the CME provider assume final responsibility for the content of programs. The ad division director had earlier touched on such agreements at a Sept. 6 Food and Drug Law Institute meeting ("The Pink Sheet" Sept. 16, p. 3). "What we've tried to do is come up with a scheme in which a drug company will reach an agreement with the provider of a CME activity before that activity occurs, and that agreement will include all the principal elements necessary to convince FDA that the program is going to be independent," Witt said. "Once that agreement is reached, the drug company can back away from the program and need not be responsible for the content." At that point, she added, the company "will not feel obliged to exercise any control over what the speakers . . . have to say, or the authors, if you are talking about written material." FDA also will consider the history of the program provider and its relationship with the industry sponsor in determining whether CME programs are being operated with sufficient independence and balance, Witt advised. "The relationship between the drug company and the provider should not be such that the drug company appears to be in a position to exert influence over the content of the activities through the provider," Witt noted. She explained that "individuals who are involved in advising or otherwise assisting the drug company with respect to sales or marketing of the drug company's product should not be involved . . . as the [CME] provider." In evaluating a program's objectivity and balance, Witt added that the agency will also determine whether the CME provider has a history of producing reputable educational activities. She said FDA "will be looking for some assurance that a provider that is selected by the sponsor has some record of generating objective, nonpromotional, educational programs and publications, and conversely, does not have a record of putting on highly promotional or sales-oriented activities." The agreements between company sponsors and CME providers should include a "fair balance" provision if the sponsor's product is to be mentioned in the program, Witt indicated. Under the agreement, Witt explained, the CME provider should agree that if a company sponsor's drug is mentioned in the program, then "both favorable and unfavorable information about that product or [a] competing product will be fairly represented, and that alternative therapies will be actively discussed." An unclear area for FDA, Witt said, is whether "experts with significant financial ties to the sponsor" should be avoided as CME program speakers. "Our original thought was the program shouldn't involve experts with significant financial relationships with the sponsor," she explained. "It's been pointed out that that may be unrealistic in today's world. One of the things that we would like to see as a way of partially dealing with these potential conflicts of interest is disclosure." What is clear to FDA is that "the drug company should not be selecting the experts, the provider should be selecting the experts." The experts, she said, should "represent a diversity of legitimate medical opinion on the topic under discussion." FDA also will look at "whether or not there are ancillary promotional activities going on at the site of the [CME program]" in determining the independence of the program, Witt told the meeting. Under the category of scientific rigor, FDA is considering whether to require CME providers to point out the limitations of any data presentations. "If data are presented with significant limitations . . . the usual example is . . . interim analyses of ongoing studies, the limitations on the reliability of such data should be clearly presented to the audience," Witt said. "We would also like the focus being on studies with adequate design to reach the conclusions that presenters are reaching on the basis of those data." The FDAer stressed that the agency's policy will not "preclude drug company funding of scientific or educational activities that do have promotional content, i.e., that have been influenced in a significant way by the drug company." However, she added, "what you need to remember is that such activities must conform to requirements for advertising and labeling, and require the company to ensure that the content does not violate the prohibitions against promotion of unapproved uses, lack of fair balance, or false or misleading content." Witt noted that FDA might have problems with a CME program being repeated at many sites around the country even if the program was considered to be independent and well-balanced. "We would have some concerns if the choice to repeat it across the country was made after the content of the original program was seen to be highly favorable to the company's product or highly unfavorable to a competitor's product," she said. "If the decision to make it available across the country were made before the initial program went on, perhaps it wouldn't be considered promotional." In response, Martin Shickman, MD, Assistant Dean for CME, University of California-Los Angeles, said: "I don't understand why if a program honestly meets the criteria of independence, balance, comprehensiveness, objectivity and rigor that you can't move it around the country." He noted that "one of the problems is that the ACCME guidelines will permit us to do that."