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FDA CME POLICY PREVENTS DISSEMINATION OF "VITAL" OFF-LABEL USE DATA

Executive Summary

FDA CME POLICY PREVENTS DISSEMINATION OF "VITAL" OFF-LABEL USE DATA, the Washington Legal Foundation charges in an Oct. 22 citizen petition on FDA's continuing medical education draft policy, which will be made final in December. The agency is "interfering with the delivery of effective health care" by disrupting the "free flow of information regarding off-label uses of FDA-approved drugs and medical devices" which is vital in certain medical areas, such as oncology, WLF claims. If WLF asserts that FDA's recent conduct has suggested that its "principal motivation is to eliminate all off-label use of approved drugs and medical devices, or at least the dissemination of information about off-label use." Off-label use "is not an evil to be tolerated," WLF objects, "but rather is an important ingredient in the delivery of quality health care." A "public interest law and policy center," WLF filed the petition "on behalf of doctors and medical patients who wish to receive information about off-label uses of FDA-approved drugs and medical devices." The non-profit group says it does not represent any drug or device firms and that a major thrust of its work is "defending the rights of individuals and businesses to go about their affairs without undue interference from government regulators." WLF maintains that FDA's recent regulatory activity and the agency's draft CME policy published in November 1992 ("The Pink Sheet" Nov. 30, 1992, p. 13) exceed the agency's statutory authority and violate the First Amendment rights of both the providers and recipients of off-label use information. In light of this, WLF asks that FDA "formally withdraw its draft policy and refrain from taking any enforcement action based on the policy or the concepts embodied in the policy." The group also asks that FDA "formally adopt a policy that recognizes the important role played by off-label uses of approved drugs and medical devices in the proper administration of health care in this country." The new policy should "declare that FDA will not interfere in non-labeling activities of drug and medical device manufacturers whose effect is to promote -- through the dissemination of truthful medical information -- off-label uses of approved drugs and medical devices," the petition explains. FDA's statutory authority to regulate drug and device labeling does not expand the definition of "labeling" to include the CME activities that FDA is trying to regulate, WLF argues. The petition cites FDA's opposition to "efforts by a major pharmaceutical company to distribute to physicians (free of charge) a standard medical textbook" and notes: "Petitioners are at a loss to understand recent efforts by FDA to brand as unauthorized 'labeling' certain manufacturer activity that does not fit within any commonly understood definition of that term." FDA cited Bristol Oncology for distribution textbooks discussing unapproved uses in May 1991 ("The Pink Sheet" June 3, 1991, p. 6). FDA's draft CME policy "does further violence to the statutory definition of 'labeling,'" WLF charges, by treating "all corporate-sponsored scientific and education programs as 'labeling' and then establishing 'safe harbors' within which a company is not likely to face enforcement action." This treatment is "totally at odds with" the statutory definition of labeling, WLF argues. In addition, given that "FDA certainly cannot claim" discussions among scientists regarding their findings relating to unapproved uses "intrinsically constitute 'labeling' for the product in question," WLF notes that "we fail to see how such discussions are converted to 'labeling' the moment that a manufacturer supplies financial support for the forum at which such discussions take place." WLF also contends that the agency is "violating the First Amendment rights of manufacturers and doctors to disseminate truthful information, and the First Amendment rights of doctors and patients to receive such information." Much of the speech "that FDA is attempting to regulate" is noncommercial, WLF argues, "because it is not uttered for the purpose of 'proposing a commercial transaction.'" The "very limited circumstances" under which the regulation of noncommercial speech is permissible do not apply in this case, WLF claims. If the speech were considered commercial, WLF notes, "FDA's actions still violate First Amendment norms." WLF argues that the CME case does not meet the three conditions necessary to permit the government to regulate commercial speech that is neither false nor related to an unlawful activity: the demonstration that "the government has a 'substantial' interest that it seeks to achieve; the regulation directly advances the asserted interest; and the regulation is no more extensive than necessary to serve that interest." The petition contends that FDA's action is not based on the claim that the off-label use is illegal or that information is inaccurate; that FDA's regulatory activities do not directly advance the interest the agency does have in the labeling of drugs and devices; and that "even if there were valid public health reasons for attempting to control the activities that FDA has been targeting, FDA's attempts at regulation have been far more extensive than necessary to achieve its purposes."
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