直接面向消费者的药品广播广告：标签外推广和遵守 FDA 指南。
Direct-to-Consumer Broadcast Advertisements for Pharmaceuticals: Off-Label Promotion and Adherence to FDA Guidelines.
机构信息
Yale School of Medicine, New Haven, CT, USA.
Yale Law School, New Haven, CT, USA.
出版信息
J Gen Intern Med. 2018 May;33(5):651-658. doi: 10.1007/s11606-017-4274-9. Epub 2018 Feb 26.
BACKGROUND
Direct-to-consumer (DTC) advertisements for prescription drugs in the United States are regulated by the Food and Drug Administration (FDA). Off-label promotion, or the advertisement of a drug for an indication not approved by the FDA, is prohibited. Our objective was to examine the presence of off-label promotion in broadcast DTC ads and to assess their adherence to FDA guidelines mandating fair balance in presentation of risks and benefits and prohibiting misleading advertisement claims.
METHODS
All English-language broadcast DTC ads for prescription drugs that aired in the United States from January 2015 to July 2016 were obtained from AdPharm, an online collection of healthcare advertisements. Ad length was measured and adherence to FDA guidelines was assessed for several categories: key regulatory items, indicators of false or misleading ads, and indicators of fair balance in presentation of risks and benefits.
RESULTS
Our sample included 97 unique DTC ads, representing 60 unique drugs and 67 unique drug-indication combinations. No ads described drug risks quantitatively, whereas drug efficacy was presented quantitatively in 25 (26%) ads. Thirteen (13%) ads, all for diabetes medications, suggested off-label uses for weight loss and blood pressure reduction. The most commonly advertised drugs were indicated for the treatment of inflammatory conditions (n = 12; 18%), diabetes or diabetic neuropathy (n = 11; 16%), bowel or bladder dysfunction (n = 6; 9%), and infections or allergic reaction (n = 6; 9%). More than three-quarters (n = 51; 76%) advertised drugs to treat chronic conditions.
CONCLUSIONS
Few broadcast DTC ads were fully compliant with FDA guidelines. The overall quality of information provided in ads was low, and suggestions of off-label promotion were common for diabetes medications. The impact of current DTC ads and off-label marketing on patient and prescriber decisions merits further scrutiny.
背景
美国食品和药物管理局（FDA）监管直接面向消费者（DTC）的处方药广告。禁止标签外促销，即未经 FDA 批准的药物广告。我们的目的是检查广播 DTC 广告中是否存在标签外促销，并评估其是否符合 FDA 准则，即要求在风险和效益的呈现上保持公平平衡，禁止误导性广告声明。
方法
从 AdPharm 在线医疗广告集中获取了 2015 年 1 月至 2016 年 7 月在美国播出的所有英语广播 DTC 处方药广告。测量广告长度，并评估以下几类广告是否符合 FDA 准则：关键监管项目、虚假或误导性广告指标以及风险和效益呈现上的公平平衡指标。
结果
我们的样本包括 97 个独特的 DTC 广告，代表 60 个独特的药物和 67 个独特的药物-适应症组合。没有广告以定量方式描述药物风险，而 25 个（26%）广告以定量方式呈现了药物疗效。13 个（13%）广告均用于糖尿病药物，暗示了减肥和降低血压的标签外用途。广告中最常宣传的药物用于治疗炎症性疾病（n=12；18%）、糖尿病或糖尿病神经病变（n=11；16%）、肠道或膀胱功能障碍（n=6；9%）以及感染或过敏反应（n=6；9%）。超过四分之三（n=51；76%）的广告宣传药物用于治疗慢性疾病。
结论
很少有广播 DTC 广告完全符合 FDA 准则。广告中提供的信息总体质量较低，糖尿病药物的标签外促销建议很常见。当前 DTC 广告和标签外营销对患者和处方医生决策的影响值得进一步研究。
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