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Executive Summary

FDA is prepared to halt open label, or "seeding," studies of already marketed drugs for unapproved uses by defining them as promotional activities, FDA Consumer Safety Officer David Banks told a Food & Drug Law Institute seminar Sept. 11. Saying that open label studies "can present a problem in that they can represent an effort to unapproved use," Banks told FDLI that "the FDA's Division of Drug Advertising and Labeling is "planning to raise the [Center for Drug Research and Evaluation's] consciousness to this issue and to do what we can to prevent these kinds of activities in the future." Banks said that the advertising group at FDA has the "seeding" technique fresh in its view because of a recent incident. An unnamed company, he reported, planned to initiate a 2,500-patient uncontrolled study of an approved drug for a use that was not approved. The company has submitted a revised protocol, which the division has rejected. The case is still open. FDA considers a clinical development program as a "seeding" study if it appears designed to plant the idea of using a drug for an unapproved use in the mind of the medical community. The proposed study was brought to the ad division's attention by a competitor that was concerned that the size of the study could establish, via a snowball effect, the drug's use for the unapproved indication among a significant portion of prescribing physicians. FDA's ad division stepped in to halt the study as a promotional activity after the medical review division said it could not stop the study because it was exempt from IND approval requirements. Asked if he felt that the ad division has the regulatory authority to halt clinical studies and to call for revised protocols, Banks remarked: "We feel no hesitation" in doing so. However, "if you mean not in terms of the scientific expertise related to the valuation of the study but actual regulatory authority, we'll see." The agency's qualms over seeding studies do not extend to post-marketing studies, Banks noted during a later Q&A session. "I want to make clear that our effort to put restrictions upon these large open label studies does not apply to the typical post-marketing seeding study of an approved use of an newly approved product." Although the agency also has "reservations" about the promotional use of post-marketing studies on approved uses, it is the unapproved uses that are of primary concern. The test case facing the agency now, Banks noted, is the "first case" of which the agency is aware in which a product was being studied in an open-label clinical where there were "no preceding adequate, well-controlled studies establishing that this product was of any worth for this unapproved use." Updating the conference on the status of the pending guidelines for drug company involvement in sponsoring continuing medical education and scientific symposia, Banks indicated that their publication continues to be far off. The guidelines have not yet cleared one of the first hurdles of review, clearance by the Center for Drug Evaluation and Research. Banks enumerated six general promotional areas that are the subject of what he called the ad division's "particular...sensitivity" with regard to symposia: * "selective presentation" or "misrepresentation of the overall body of available data"; * "promotion of unapproved uses" should "by and large" be "a topic rather than the topic"; * the "extent to which a firm has previously sponsored unapproved use discussions"; * claims of "undemonstrated superiority or claims of superiority demonstrated only by means of uncontrolled studies or other studies that are not adequate and well controlled"; * "road shows"; * "repeated" discussions of an unapproved use if a firm is not going to develop that unapproved use for marketing; * and "unavoidable misrepresentations" for which companies should be prepared voluntarily to disseminate corrective or additional material. One "significant issue" at the ad division, Banks told FDLI, is the upcoming Senate hearings on drug marketing practices by Sen. Kennedy (D-Mass.). "Inducements [to conference attendees] and conflict of interest are a "concern that we've had for some time," Banks said. "We consider it an important part" of the entire matter of industry-sponsored medical education and science symposia. FDA is particularly interested in symposia presentations by physicians who have become part of a drug company's "stable" by virtue of gaining expertise on the product through company-sponsored research, Banks indicated. "We don't see this conflict of interest as a fatal flaw but it's something that cannot be ignored," he said, suggesting: "We have to think in terms of disclosure of these individuals' ties to the sponsoring firm as one means of addressing this inherent conflict of interest." The content of information presented by these physicians at symposia is "even more firmly entrenched as our primary consideration," the FDAer remarked, and the "proportion of time devoted to [promotional] activities is of increasing concern to us." Banks described as "one of our greatest concerns" the "hypothetical 'fly-away' seminar" where companies provide airfare, lodging, meals, entertainment, etc. Saying that the setting of a symposium is "increasingly seen by our group as an indicator of the quality of the content," Banks told the FDLI group: "I think this is an area of excruciating vulnerability to the industry" that has "to a significant extent given the industry a black eye." Discussing the future of how FDA will view company-sponsored continuing medical education, Banks said he envisions three tiers of sponsorship quality: "the BMW tier, the Chevrolet tier and the Rent-a-Wreck tier." Describing the third tier as firms that "consistently" provide inducements "in order to assure attendance," he warned that "obviously that's the group that needs to be most concerned about the potential threat" from FDA. He assured the seminar audience that in the middle tier FDA recognizes that "there is perhaps a certain limitation in the ability of the sponsoring firm to discern the true level of quality of the activities. I think in this area there is an undue degree of concern" by industry, he said, adding: "I think that the typical Chevrolet activity is not really vulnerable to adverse regulatory consequences." In that regard, independence of the continuing medical education provider from the sponsoring firm "was at one point a major criterion" for FDA's regulatory review of such activities, Banks noted. However, "I would say at this point it is of diminishing concern."

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