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AMA OVERTURNS LONG-STANDING DIRECT-TO-CONSUMER Rx AD BAN, PROVIDING ADS HAVE "EDUCATION" VALUE AND PHYSICIAN EDUCATION MATERIALS ARE MADE AVAILABLE

Executive Summary

The American Medical Association will revoke its long-held categorical opposition to direct-to-consumer prescription drug advertising, AMA's House of Delegates agreed during their annual policy-setting meeting June 21-25 in Chicago. In previous years, AMA consistently voted to express general opposition to product-specific consumer advertising. The group currently will not accept such ads in its own consumer-oriented materials. But the AMA delegates voted June 23 to modify that stance, although they couched their support in terms of focusing on "health education" ads and attached a number of stipulations. The resolution states that AMA will "amend the current blanket ban on product-specific, direct-to-consumer advertising to allow that the American Medical Association on a case-by-case basis [may] accept disease-specific health education consumer ads, which may include mention of brandname prescription drugs." The resolution adds that "acceptance of such ads, including placement in AMA consumer communications, will occur only in those instances in which the ads are in the patient's interest, [and] conform to new standards and guidelines to be jointly developed by the FDA and AMA." The final statement was developed by a delegates' Committee on Science, Technology and Public Health, which held a hearing on several drug-related items on June 22. The easing of the ad ban was proposed by AMA's Board of Trustees. The science review committee reported that it heard "testimony from the Board of Trustees requesting this limited exception to existing policy, which opposes any advertising of prescription drugs to the public. It was asserted that these recommendations afford the AMA an opportunity to assume a proactive leadership role in the expansion and dissemination of medication information, an area of increasing physician, patient, and regulatory body interest." The approved resolution states that acceptable ads must contain a "clear, accurate and responsible healthe ducation or disease prevention message and include referring patients to their physicians for more information when appropriate." The delegates also agreed to a proposal by AMA's Board of Trustees that ads carried in AMA publications must contain a disclaimer that AMA is not endorsing any product mentioned. * After the delegates' session, AMA Exec VP James Todd, MD, was asked if it might be "self-serving" for AMA to revise its policy on ads, given the association's expansion into consumer publications and television. The "average cynic would say that," Todd agreed, but added that when the association develops a new policy on an issue such as this and includes "checks and balances" in it, "we are serious about it." Todd said AMA already rejects advertisement submissions "all the time," and, although the association receives "a lot" of ad revenue, direct-to-consumer ads probably will provide a "very small amount" of income. Emphasizing the public education potential of consumer ads, Todd cited pneumococcal vaccines, nonsedating antihistamines and "single dose heart drugs" as the types of products consumers might benefit from learning about through advertisements. The criteria included in AMA's resolution stipulate that ads may not make comparative claims; the manufacturer of the product named in the ad must make physician education materials available; and the manufacturer "agrees that there will be no incentive programs for physician presciibing and pharmacists." AMA has not detailed how it plans to work with FDA on developing ad guidelines. A separate AMA report on health care financing reform expresses concern about the effect of "aggressive marketing" of medical technologies on health expenditures. AMA plans to analyze this issue, including the impact of marketing "before adequate clinical trials" are completed. In other actions June 23, the AMA policymaking body agreed to "support the use of patient controlled analgesia, when not contraindicated, as one of several effective analgesic methods," noting that such technologies are recommended in pain management guidelines recently issued by HHS' Agency for Health Care Policy and Research; to "craft and disseminate to state medical societies model state legislation standardizing 'dispense as written' language" for physicians to specify dispensing of a brandname drug only; to urge AMA constitutent groups to "encourage doctors to improve the legibility of handwritten orders for medications" in order to reduce dispensing errors; and to "continue to monitor and evaluate proposed changes in the FDA and respond as appropriate." The last resolution is aimed at monitoring implementation of any recommendations made by the "Edwards Committee" blue ribbon panel on FDA. A proposed resolution supporting increased subpoena powers for FDA ("The Pink Sheet" June 16, T&G-9) was withdrawn by its sponsors because the Bush Administration currently does not support pending FDA "enforcement" legislation that includes those powers. * The House of Delegates also voted to "disseminate the guidelines for the treatment of Lyme disease developed by the American Academy of Pediatrics and as published in the AMA publication, Drug Evaluations." The science review committee reported that it "heard testimony that decried the chronic use of intravenous antibiotics in the treatment of Lyme disease. The use of intravenous antibiotics in the treatment of Lyme disease is not recommended for more than 14- 21 days" in both the AAP guidelines and AMA's compendium. One physician addressing the committee said Lyme disease treatment "mills" have sprung up, and he indicated that they treat patients with unnecessarily high doses of antibiotic therapies. AMA "should enlist the aid of the Pharmaceutical Manufacturers Association in encouraging manufacturers to develop new drugs and vaccines for tuberculosis," another adopted recommendation states. It also calls for increased federal funding for research related to tuberculosis drug therapies and vaccines. The recommendation is part of a larger report on the spread of multi-drug resistant tuberculosis that spotlights the link between the tuberculosis- and HIV-infected populations. Drug prices were tangentially noted in the health care reform report, which was approved June 24. The report states that AMA will "seek discussions" with national organizations including PMA "regarding development of guidelines for the release of price information on hospital charges, drugs and medical devices to physicians and the public." But delegates also supported a separate resolution that "AMA shall not endorse price fixing in any form; or budget predictability achieved by expenditure targets, budget caps or global budget limits." John Clowe, MD, was installed as AMA's 147th president during the Chicago meeting. He is a family practitioner and attending physician at several Schenectady, N.Y.-area hospitals. AMA's president-elect is Joseph Painter, MD, VP of the M. D. Anderson Cancer Center in Texas.
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