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Executive Summary

FDA's draft concept paper on "Drug Company Supported Activities in Scientific or Educational Contexts" is "overly broad" in scope and should address only symposia and responses to spontaneous requests for information, Merck Sharp & Dohme said in comments on the document. "Issues surrounding company-supported medical journals, supplements to journals, television programs, videotapes, software, etc., have different regulatory and practical considerations so that many of the principles and assumptions underlying the criteria in the concept paper are not applicable and would raise more questions than would be resolved if applied to these other activities," Merck said. "If FDA believes that such activities need to be dealt with, this should be addressed in separate concept papers, guidelines or policies." Merck's comments were among 206 submissions received by the agency during November and December on its draft policy statement. The document was released in October ("The Pink Sheet" Oct. 28, 1991, p. 3). The agency says that a second version of the document will be out soon ("The Pink Sheet" March 2, p. 4). Many of the comments from industry, the medical community, other government agencies, and third-party CME and publishing groups took issue with various aspects of FDA's proposals to regulate publications and other materials sponsored by pharmaceutical firms. Alza, for example, argued that the proposed policy's prohibition against using company-reimbursed writers to prepare medical articles "would hamper medical education and the dissemination of accurate, clear information on drugs." A Duke Medical Center CME Director, responding on a worksheet circulated by Merck, attached an article for which he said the first draft was written by a drug company. The article still provided an "exhaustive review" of the subject, he maintained. MSD apparently circulated the worksheet on CME programs to academic institutions to elicit their active participation in the process of responding to FDA. In addition to Alza and Merck, seven drug companies submitted comments: Pfizer, Ciba-Geigy, Hoechst-Roussell, Immunex, Synergen, Burroughs Wellcome and Connaught. The Pharmaceutical Manufacturers Association and the Industrial Biotechnology Association also responded. One of the common concerns raised by the respondents was the difficulty posed to companies by the apparent requirement for them to exert no control over the content of a symposium but also to be held accountable for what is said. FDA Division of Drug Marketing, Advertising and Communications Senior Regulatory Review Officer David Banks recently reassured the industry that FDA would limit potential liability of companies who "undertake good faith efforts" to ensure that symposia are independent ("The Pink Sheet" Feb. 10, T&G-11). In its comments to the agency, Synergen suggested that rather than limit company liability for independent symposia, FDA should allow the drug company to "be directly involved in the program." Synergen continued: "It is the responsibility of the pharmaceutical company's medical and professional services department to understand and practice the guidelines for scientific exchange. Proper action should be taken by the FDA for any violators of these guidelines." Synergen was joined by the Industrial Biotechnology Association and many other respondents in commenting on FDA's attempt to delineate the appropriate roles for marketing and science groups within companies. "In our company, individuals from clinical, scientific, marketing and sales groups interact closely and plan for our ultimate commercial success," Synergen said. "We have strived to avoid the kind of departmentalization that is characteristic of large companies and that is assumed in your guidelines to reflect the organization of all pharmaceutical companies." FDA's attempt to tell companies who should perform what functions in regard to CME programs reflects a new "process" approach to promotion regulation. The agency recently castigated Marion Merrell Dow for failing to change its promotional approval procedures in the wake of a dispute with the agency over a detail brochure for Cardizem ("The Pink Sheet," March 2, p. 8). The agency regulates GMP (manufacturing and production) controls with a process approach and may be heading toward that type of approach for promotions. Industry, the medical community and CME providers showed widespread agreement in objecting to several provisions proposed by FDA. For example, the draft proposes that: CME should focus on "a variety of treatments" for a disease. Healthcare communications company Castelli Associates said that there are "two scenarios in which the focus can be on a single product": the first is when "a new agent is the first of a major new class and represents a new modality (i.e. Mevacor). The second is when a major study is reported." The American Heart Association noted that to ensure the legitimacy of discussing a single drug "it would be appropriate (in the agreement [between a company and a CME provider] and in disseminated materials) to delineate the reasons and purposes for which a single drug is the main or only topic." "Live scientific activities, e.g., symposia, should ordinarily not be repeated." Washington law firm Kleinfeld, Kaplan, and Becker, representing Grey Advertising Inc. subsidiary Phase V Communications, stated: "To the extent that an event meets all applicable criteria on a one-time basis, repeating such an event merely allows additional physicians to obtain the benefit of the same educational information." AMA said: "We believe that accredited CME events should be repeatable, although the decision and the responsibility should be that of the accredited provider/sponsor." "Discussions of unapproved uses will be especially objective and scientifically rigorous." Respondents contended that off-label use is often the standard of care, especially in cancer treatment. Cancer Care Inc. argued that off-label uses are "vital to state-of-the-art cancer treatment" and "to inhibit discussions of new drug uses which may be of clinical not in the best interests of patients." FDA Oncology Division reviewer Grant Williams, MD, argued that "in the field of cancer research, we should err on the side of allowing promotion as a spin-off of investigator communications rather than erring on the side of squelching communication." "The drug company should play no role in the selection of presenters or authors." Castelli Associates commented, "Often, the company knows the field best and the provider has more limited knowledge" and "we propose that a company be permitted to suggest experts, and in doing so be required to provide reasons for their suggestions." The AMA also espoused this argument, "as long as the final selection is done independently." "The drug company should agree not to have any promotional activities in proximity to the educational activity." The Coalition of Healthcare Communicators agreed, but stated that this "should not prohibit the required acknowledgement of the funding company's support for the activity, the utilization of company personnel to participate in the announcement of the independent program, or their personal attendence." AHA stated that "under certain situations, it is appropriate and feasible to have an independent educational activity and a promotional activity at the same meeting if they are clearly identified and are physically separate." "The provider should agree that in the case of live oral presentations, printed full reports of the research discussed are provided." The Coalition countered that this requirement "will stifle the free exchange of scientific information. If the author complied with this requirement, the research would no longer be admissible to most high-quality medical journals." The AMA said, "this requirement will not be practical for most live CME activities... it is illegal to photocopy articles without permission, and a lengthy lead time to obtain permission from the authors and publisher is necessary." Many of these issues already have been addressed by FDA in public comments. Adams told a Food & Drug Law Institute meeting that the agency is "not contemplating a blanket prohibition on repeat performances" ("The Pink Sheet" March 2, p. 4). Adams also addressed the issue of a "variety of treatments" and indicated that the next draft of the policy may recognize that in some cases discussion of a single treatment may be appropriate.

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