The American Urological Association (AUA) and the Urology Care Foundation endorse the following American Medical Association policy regarding Direct to Consumer Marketing:
H-105.988 Direct-to-Consumer Advertising (DTCA) of Prescription Drugs and Implantable Devices.
(1) Our AMA considers acceptable only those product-specific direct-to-consumer (DTC) advertisements that satisfy the following guidelines:
(a) The advertisement should be indication-specific and enhance consumer education about both the drug or implantable medical device, and the disease, disorder, or condition for which the drug or device is used; (b) In addition to creating awareness about a drug or implantable medical device for the treatment or prevention of a disease, disorder, or condition, the advertisement should convey a clear, accurate and responsible health education message (i.e., information on the prevention or treatment of a disease, disorder, or condition) by providing objective information about the benefits and risks of the drug or implantable medical device for a given indication. Information about benefits should reflect the true efficacy of the drug or implantable medical device as determined by clinical trial that resulted in the drugâ€™s or deviceâ€™s approval for marketing; (c) The advertisement should clearly indicate the product is a prescription drug or implantable medical device to distinguish such advertising from other advertising for nonprescription products; (d) The ad should not encourage self-diagnosis and self-treatment, but should refer patients to their physicians for more information; (e) Discussion of the use of the drug product for the disease, disorder, or condition should exhibit fair balance between benefit and risk information; (f) Warnings, precautions, and potential adverse reactions associated with the drug or implantable medical device should be clearly explained in a manner such that it will be understood by a majority of consumers, without distraction on content, and will help facilitate communication between physician and patient; (g) No comparative claims should be made for the product; however the ad should include information about the availability of alternative non-drug or non-operative management options such as diet and lifestyle changes, where appropriate for the disease, disorder, or condition; (h) The product-specific DTC advertisements should not use an actor to portray a health care professional who promotes the drug or implantable medical device product, because this portrayal may be misleading and deceptive. If actors portray health care professionals in DTC ads, a disclaimer should be prominently displayed; (i) The use of actual health care professionals, either practicing or retired, in DTC to endorse a specific drug or implantable medical device product is discouraged but if utilized, the ad must include a clearly visible disclaimer that the health care professional is compensated for the endorsement; (j). The ad should be targeted for placement in print, broadcast, or other electronic media so as to avoid audiences that are not age appropriate for the messages involved.; and (k) The advertisement must comply with applicable FDA rules, regulations, policies and guidelines.
(2) Our AMA opposes product-specific DTC advertisements, regardless of medium, that do not follow the above AMA guidelines.
(3) The FDA review and pre-approve all DTC advertisements for prescription drug or implantable medical device products before pharmaceutical and medical device manufacturers (sponsors) run the ads, both to ensure compliance with federal regulations and consistency with FDA-approved labeling for the drug or implantable medical device product.
(4) Congress provide sufficient funding to the FDA, either through direct appropriations or through prescription drug or medical device user fees, to ensure effective regulation of DTC.
(5) DTC advertisements for newly approved prescription drug or implantable medical device products not be run until physicians have been appropriately educated about the drug or implantable medical device.
(6) Our AMA opposes any manufacturer (drug or device sponsor) incentive programs for physician prescribing and pharmacist dispensing that are run concurrently with DTC ads.
(7) Our AMA encourages the FDA, other appropriate federal agencies, and the pharmaceutical industry to conduct or fund research on the effect of DTC, 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.
(8) Our AMA supports the concept that when companies engage in DTC, 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.
(9) Our AMA encourages physicians to be familiar with the above AMA guidelines for product-specific DTC 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.
(10) Congress should request the Agency for Healthcare Research and Quality to perform periodic evidence-based reviews of DTC in the United States to determine the impact of DTC on health outcomes and the public health.
(11) Our AMA continues to monitor DTC, including new research findings, and work with the FDA and the pharmaceutical and medical device industries to make policy changes regarding DTC, as necessary.
(12) Our AMA supports "help seeking" or "disease awareness" advertisements (i.e., ads that discuss a disease, disorder, or condition and advice consumers to see their physicians, but do not mention a drug or implantable medical device or other medical product and are not regulated by the FDA).
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; Reaffirmed A-04; Reaffirmed A-05; Modified: BOT Rep. 9, A-06; Reaffirmed in lieu of Res. 514, A-07))
Board of Directors, May 2004
Board of Directors, October 2008 (Revised)
Board of Directors, October 2013 (Revised)
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