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FDA POSITION ON MEDICAL TEXTBOOKS AND JOURNAL SUPPLEMENTS

Executive Summary

FDA POSITION ON MEDICAL TEXTBOOKS AND JOURNAL SUPPLEMENTS that are produced or disseminated by drug companies may be addressed in a future policy statement, FDA Policy Development and Coordination Staff Director David Adams told the Drug Information Association at a March 11 meeting on drug marketing and promotion in New York City. "I think that there is a growing need at this time for a separate policy statement or...some sort of expression of policy on how the agency views or regulates written materials that are scientific or educational in nature, such as journals, journal supplements, articles, medical textbooks, other sorts of published materials that companies are involved in producing or disseminating," Adams said. He noted that "this is an area of considerable controversy, and the agency has to be careful not to [unduly] restrict the flow of information out from companies." Bristol-Myers Squibb ran into trouble with FDA in 1991 over its controlled-circulation publication, "Oncology Commentary '90", which the agency claimed promoted cancer drugs for unapproved uses. In 1992, FDA told BMS that it would not okay the firm's plan to distribute excerpts from an oncology textbook that contain discussions of unapproved uses of BMS' cancer products. FDA determined that the entire textbook could be distributed as a service of BMS, but only through a third party. ("The Pink Sheet" July 13, 1992, T&G-14). McGraw-Hill's Jim Dougherty commented on Adams' discussion of enduring educational materials, saying: "As a publisher [of a peer-reviewed medical journal], I am particularly concerned by FDA moves to restrict distribution by drug companies of independent textbooks based on the fact that [they] contain off-label references." These moves, Dougherty said, "ultimately limit educational communication [and] options and...are ultimately counterproductive for patients." He pointed out that "in most cases, the FDA-approved package insert is not considered state-of-the-art therapy." Dougherty stated: "It's very difficult for me to believe that a gross extension of regulation over printed materials could possibly make the [continuing medical education] system more effective or more efficient." The agency "contends that they're enforcing the law. In fact, they are enforcing their interpretation of the law. The interpretation as it relates to publishing may have to go to the courts for further interpretation," he concluded. As an alternative to FDA regulation, the publisher suggested that "there are a variety of organizations such as the Council of Biology Editors, the Society of Magazine Editors and the Association of Medical Publishers, and perhaps even [the Accreditation Council for Continuing Medical Education] that represent the kind of bodies that are appropriate to develop and monitor standards for publications." Another area that FDA is interested in looking into is company-sponsored educational programs to consumers. Adams said that "we may also be facing new and [different] issues involving educational programs that are directed [more to consumers] than healthcare professionals." He added: "We're seeing a little more of this than we used to, and I think there will be a number of interesting issues that we may need to address in that context." Some industry attorneys are understood to have floated to FDA the idea of companies funding independent, educational activities for consumers about drug products. In response to FDA's request for comments on its draft policy statement on CME, "the agency now has 140 comments," Adams said. "We are starting to look at those comments" (see preceding T&G). He noted that the comments "have generally been favorable and complimentary within the healthcare community, complimenting the process by which the agency arrived at this new document and complimenting the manner in which the agency addressed many of the concerns." R. Van Harrison, PhD, the director of the CME office at the University of Michigan Medical School, called organized medicine's reaction to FDA's CME policy "very positive." To help clarify FDA's policy statement, Van Harrison said ACCME is "developing a number of other detailed documents, one of which is a set of questions and answers of hypothetical issues." ACCME is "working out pilot studies of its new auditing process of CME providers, which I should add, is being funded fairly generously by grants from pharmaceutical companies to help get that process in place." Toward the end of March, ACCME will hold a meeting to review "a number of draft operational documents, including a proposed model for a written agreement that will be officially endorsed by the ACCME as a working model," he noted.
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