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Reference Committee K Reference Committee K BOT Report(s) 09 Product-Specific Direct-to-Consumer Advertising of Prescription Drugs CSAPH Report(s) 01 Urine Drug Testing 03 Genome Editing and its Potential Clinical Use 04 Hormone Therapies: Off-Label Uses and Unapproved Formulations Resolution(s) 901 Disclosure of Screening Test Risks and Benefits, Performed Without a Doctor's Order 902 Removing Restrictions on Federal Public Health Crisis Research 903 Prevention of Newborn Falls in Hospitals 904 Improving Mental Health at Colleges and Universities for Undergraduates 905 Chronic Traumatic Encephalopathy (CTE) Awareness 906 Universal Color Scheme for Respiratory Inhalers 907 Clinical Implications and Policy Considerations of Cannabis Use 908 Faith and Mental Health 909 Promoting Retrospective and Cohort Studies on Pregnant Women and Their Children 910 Disparities in Public Education as a Crisis in Public Health and Civil Rights 911 Importance of Oral Health in Medical Practice 912 Neuropathic Pain Recognized as a Disease 913 Improving Genetic Testing and Counseling Services in Hospitals and Healthcare Systems 914 Needle / Syringe Disposal 915 Women and Alzheimer's Disease 916 Women and Pre-Exposure Prophylaxis (PrEP) 917 Youth Incarceration in Adult Prisons 918 Ensuring Cancer Patient Access to Pain Medication 919 Coal-Tar Based Sealcoat Threat to Human Health and the Environment 920 Haptenation and Hypersensitivity Disorders Communication 921 Raise the Minimum Age of Legal Access to Tobacco to 21 Years 922 Responsible Parenting and Access to Family Planning 923 Reverse Onus in the Manufacture and Use of Chemicals 924 AMA Advocacy for Environmental Sustainability and Climate 925* Graphic Warning Label on all Cigarette Packages * contained in Handbook Addendum REPORT OF THE BOARD OF TRUSTEES B of T Report 9-I-16 Subject: Product-Specific Direct-to-Consumer Advertising of Prescription Drugs (Second Resolve, Resolution 927-I-15; Resolution 514-A-16) Presented by: Patrice A. Harris, MD, MA, Chair Referred to: Reference Committee K (Paul A. Friedrichs, MD, Chair) 1 INTRODUCTION 2 3 The second resolve of Substitute Resolution 927-I-15, “Ban Direct-To-Consumer Advertisements 4 of Prescription Drugs and Implantable Medical Devices,” referred for decision by the House of 5 Delegates (HOD), and then directed for a report back1 by the Board of Trustees asked: 6 7 That Policy H-105.988, “Direct-to-Consumer Advertising of Prescription Drugs and 8 Implantable Medical Devices,” be rescinded. 9 10 Resolution 514-A-16, “Opposing Tax Deductions for Direct-to-Consumer Advertising,” introduced 11 by the California Delegation and referred by the HOD asked: 12 13 That our American Medical Association oppose allowing costs for direct-to-consumer 14 advertising of prescription medications, medical devices, and controlled drugs to be considered 15 deductible business expenses for tax purposes. 16 17 AMA Policy H-105.986, “Ban Direct-to-Consumer Advertisements of Prescription Drugs and 18 Implantable Devices,” supports a ban on direct-to-consumer advertising for prescription drugs and 19 implantable medical devices. Policy H-105.988 contains a detailed set of guidelines for 20 establishing what the AMA considers to be acceptable product-specific direct-to-consumer 21 advertisements (DTCA) for prescription drugs and implantable medical devices. Although AMA 22 policy supports a ban on DTCA, it may be reasonable and prudent to maintain a policy that 23 provides a framework to evaluate the appropriateness and/or usefulness of DTCA, based 24 principally on the fact that the Supreme Court has ruled that DTCA is protected commercial free 25 speech and therefore, this practice will likely continue in the future. This report summarizes 26 concerns and findings on the impact of DTCA and whether the AMA should maintain a 27 comprehensive policy on what constitutes acceptable product-specific DTCA. Additionally, this 28 report briefly considers whether establishing policy opposing industry tax credits for DTCA is 29 advisable. 30 31 BACKGROUND 32 33 Food and Drug Administration Regulation of DTCA 34 35 Pharmaceutical companies began marketing prescription drugs directly to consumers in the early 36 1980s. In 1983, the Food and Drug Administration (FDA) imposed a moratorium on DTCA, to © 2016 American Medical Association. All rights reserved. B of T Rep. 9-I-16 -- page 2 of 9 1 which the industry agreed. Two years later, based on the legal view that DTCA is constitutionally 2 protected free speech, the FDA concluded that it lacked the legal authority to prevent this type of 3 advertising and agreed to allow it as long as DTCAs: (1) were not false or misleading; (2) 4 presented a fair balance between benefit and risk information; and (3) revealed all material facts 5 about risks in the form of a so-called “brief summary.” The latter required that ads provide 6 sufficient information about warnings, precautions, and side effects associated with prescription 7 drug products. Based on these substantial informational requirements, most product-specific 8 DTCAs in the 1980s and 1990s were largely restricted to print media. 9 10 In 1999, the FDA acted to facilitate DTCA via broadcast media by finalizing the Agency’s 11 “Guidance for Industry: Consumer-Directed Broadcast Advertisements.”2 This Guidance relaxed 12 the responsibilities for the industry with respect to providing risk information in DTCA. The key 13 new provision was that the FDA now required pharmaceutical manufacturers to provide only risk 14 information related to the major side effects and contraindications of the advertised drugs in the 15 audio or visual portion of the broadcast (referred to as the “major statement”) and make “adequate 16 provision” for obtaining the full prescribing information in connection with the advertisement.3 The 17 latter could be accomplished by referral to a company-designated toll free phone number or web 18 page, a print advertisement for the product or referral to the patient’s physician or pharmacist for 19 additional information. 20 21 With these changes, the appearance of DTCA in broadcast media increased substantially. By 2006, 22 the industry was spending $5.4 billion annually on DTCA. The 2007 Food and Drug 23 Administration Amendments Act gave the FDA the authority to require submission of any television 24 drug advertisement for advisory review not later than 45 days before the ad is publicly 25 disseminated. Although the FDA can make certain recommendations for the DTCA based on 26 information included in the drug’s package insert (including addressing efficacy of the drug in 27 specific populations), it has no authority to require changes except for specific disclosure about 28 serious risks, or the date of approval, if the ad would otherwise be deemed false or misleading. In 29 2012, the FDA issued draft guidance for industry on how it planned to implement the requirement 30 for the pre-dissemination review of DTCA.3 This guidance establishes several categories of 31 television ads subject to pre-dissemination review (e.g., initial ads for a new drug, any drug with a 32 Risk Evaluation and Mitigation Strategy, controlled substances, and any drug with a black box 33 warning). The FDA’s Office of Prescription Drug Promotion (OPDP) is responsible for reviewing 34 prescription drug advertising and promotional labeling to ensure the information contained in the 35 promotional materials is not false or misleading. OPDP also encourages health care providers to 36 report misleading ads through the Bad Ad program. 37 38 The regulatory structure around certain aspects of DTCA may change as the FDA moves to enact 39 new regulations regarding risk communication. In 2015, the FDA sought public comments on new 40 guidance for pharmaceutical marketers on communicating risks to consumers in print 41 advertisements. The Agency’s proposal is based on accumulated research showing that reprinting 42 highly technical language in print advertisements does very little to communicate risks to 43 consumers. Rather, the FDA is proposing that companies use a new “consumer brief summary” 44 focused on the most important risk information in a way most likely to be understood by 45 consumers. This would move the requirements for risk communication in print advertisements in 46 the same direction as previously made for broadcast advertisements. 47 48 DTCA-Pro or Con? 49 50 The United States is one of only two countries in the world that allows DTCA in broadcast, print, 51 and electronic media; the other is New Zealand. Last year the industry spent $5.4 billion on such B of T Rep. 9-I-16 -- page 3 of 9 1 advertising, a 58% increase from 2012, and equivalent to the peak spending last achieved in 2 2006.4 During the same time period, the proportion of total DTCA spending devoted to television 3 increased from 57% to 69%. Considerable debate has focused on whether DTCA is beneficial or 4 harmful to patients or the patient/physician relationship, and whether physician prescribing 5 behavior is significantly affected. 6 7 The following lists the major pro and con arguments that have been made regarding DTCA: 8 9 Arguments in Support of DTCA 10 11 • Educates patients and encourages patient responsibility for their health. 12 • Increases patient awareness of medical conditions and treatment options. 13 • Encourages patients to contact their physician, or otherwise engage the healthcare system. 14 • Results in cost savings; by seeking medical attention, patients have their conditions 15 managed in a more prompt fashion, avoiding unneeded hospital stays or more costly 16 interventions. 17 • Stimulates thoughtful dialogue and strengthens a patient’s relationship with their health 18 care provider. 19 • Encourages patient adherence, with drug ads serving as reminder aids. 20 • Reduces underdiagnoses and undertreatment of certain conditions or diseases. 21 • Removes the stigma associated with certain diseases. 22 23 Arguments Opposing DTCA 24 25 • Misinforms patients by omitting important information or using an inappropriate literacy 26 level.
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