Resolution: 507 (A-05)

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Resolution: 507

Introduced by: Wisconsin Delegation
Subject: Prohibit Direct-to-Consumer Prescription Drug Advertising
Referred to: Reference Committee E

(Daniel W. van Heeckeren, MD, Chair)

Whereas, Direct-to-consumer advertising of prescription drugs promotes drugs to consumers that are potentially dangerous enough to require medical prescription; and
Whereas, Direct-to-consumer advertising of prescription drugs is designed to undermine doctors’ independent professional judgment; and
Whereas, Prescription drugs promoted to the public have in some cases subsequently been determined to pose substantial risk to health; and
Whereas, Direct-to-consumer advertising of prescription drugs is inherently misleading in that it promotes products considered inherently risky enough that state law does not permit direct sale to consumers; and
Whereas, Direct-to-consumer advertising of prescription drugs significantly increases the overall cost of drug therapy by specifically promoting expensive, patented high-profit drugs, thereby unnecessarily driving up costs of medical care in Wisconsin; therefore be it
RESOLVED, That our American Medical Association recognize and support efforts to control direct-to-consumer advertising of prescription drugs and work to strengthen federal efforts to more effectively regulate such advertising. (New HOD Policy)

Fiscal Note: Staff cost estimated at less than $500 to implement.

Received: 5/5/05
H-105.988 Direct-to-Consumer Advertising (DTCA) of Prescription Drugs

(1) Our AMA considers acceptable those product-specific direct-to-consumer advertisements (DTCA) that follow the guidelines for such advertisements that were developed by the AMA, in consultation with the FDA, in 1993. These guidelines also apply to DTC A of FDA approved medical devices, and are as follows: (a) The advertisement should be disease-specific and enhance consumer education; (b) The ad should convey a clear, accurate and responsible health education message (i.e., information on the prevention or treatment of a disease, disorder, or condition); (c) In all cases, the ad should refer patients to their physicians for more information; (d) The ad should not encourage self-diagnosis and self-treatment, but should identify the consumer population at risk; (e). Discussion of the use of the drug product for the disease, disorder, or condition should exhibit fair balance; (f) Warnings, precautions, and potential adverse reactions associated with the drug product should be clearly explained so as to facilitate communication between physician and patient; (g) No comparative claims can be made for the product. In the interest of fair balance, alternative non-drug management options for the disease, disorder, or condition can be included; (h) The brief summary information should be presented in language that can be understood by the consumer; (i) The advertisement must comply with applicable FDA rules, regulations, policies and guidelines as provided by their Division of Drug Marketing, Advertising and Communications; (j). The ad should be part of a manufacturer’s education program that would include collateral materials to educate both physician and consumer; and (k) The manufacturer should not run concurrent incentive programs for physician prescribing and pharmacist dispensing. (2) Our AMA opposes product-specific DTC advertisements, regardless of medium, that do not follow the above AMA guidelines. (3) Our AMA encourages the FDA, other appropriate federal agencies, and the pharmaceutical industry to conduct or fund research on the effect of DTCA, focusing on its impact on the patient-physician relationship as well as overall health outcomes and cost benefit analyses; research results should be available to the public. (4) Our AMA supports the concept that when companies engage in DTCA, they assume an increased responsibility for the informational content, an increased duty to warn consumers, and they may lose an element of protection normally accorded under the learned intermediary doctrine. (5) Our AMA encourages physicians to be familiar with the above AMA guidelines for product-specific DTCA and with the Council on Ethical and Judicial Affairs (CEJA) Ethical Opinion E-5.015 and to adhere to the ethical guidance provided in that Opinion. (6) Our AMA continues to monitor DTCA, including new research findings, and work with the FDA and the pharmaceutical industry to make policy changes regarding DTCA, as necessary. (7) Our AMA advocates that direct-to-consumer prescription drug and medical device advertisements contain the disclaimer "Your physician may recommend other, appropriate treatments." (BOT Rep. 38 and Sub. Res. 513, A-99; Reaffirmed: CMS Rep. 9, Amended: Res. 509, and Reaffirmation I-99; Appended & Reaffirmed: Sub. Res. 503, A-01; Reaffirmed: Res. 522, A-02; Reaffirmed: Res. 914, I-02; Reaffirmed: Sub. Res. 504, A-03; Reaffirmation A-04)
H-105.992 Pharmaceutical Advertising

Our AMA supports calling upon the pharmaceutical industry to work with the AMA to promote print and electronic advertising that will educate the American public not only as to the beneficial effects of their over-the-counter products but also to the potential adverse effects of indiscriminate use of those same products. (Res. 92, I-89; Reaffirmed: Sunset Report, A-00)

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