Findlay S D
National Institute for Health Care Management Foundation, Washington, DC, USA.
Pharmacoeconomics. 2001;19(2):109-19. doi: 10.2165/00019053-200119020-00001.
Spending on outpatient prescription drugs in the US is accelerating rapidly. Although numerous factors are driving this trend, attention has recently focused on the role played by the marketing, promotion and advertising of pharmaceuticals, in particular direct-to-consumer (DTC) advertising. In 1997, the US Food and Drug Administration (FDA) issued a 'guidance' on such mass media promotion. The guidance altered existing FDA rules and effectively permitted pharmaceutical companies to promote prescription drugs on television and radio without giving detailed or even summary information on indications, efficacy or potential adverse effects. Since then, television commercials, in particular, and print advertisements in consumer magazines and newspapers have proliferated rapidly. Pharmaceutical companies spent $US1.8 billion on DTC advertising in 1999, a 40% increase over 1998. This spending in 1999 was heavily concentrated on about 50 drugs. Evidence is growing that DTC promotion of prescription drugs is: (i) alerting consumers to the existence of new drugs and the conditions they treat; (ii) increasing consumer demand for many drugs; (iii) contributing increasingly to the recent sharp increase in the number of prescriptions being dispensed; (iv) raising sales revenues; and, thus, (v) contributing to the higher pharmaceutical costs of health insurers, government and consumers. The public policy issues surrounding DTC advertisements centre on the following questions: (i) are the advertisements leading to the inappropriate clinical use of some drugs? (ii) are the advertisements inducing both consumers and physicians to choose more costly new brand-name drugs over less expensive, but equally effective, older brand or generic drugs? (iii) do television advertisements for prescription drugs contain a balanced amount of information on benefits versus potential adverse effects? and (iv) will the revenue benefits generated by DTC advertising cause pharmaceutical companies to focus more on developing products to treat prevalent but not life-threatening conditions, such as baldness, sexual dysfunction or memory loss? These questions are just beginning to be probed despite prescription drug spending, insurance coverage and payment policies having become major political issues in the US.
美国门诊处方药支出正在迅速加速增长。尽管有众多因素推动这一趋势，但最近人们的注意力集中在药品营销、推广和广告所起的作用上，特别是直接面向消费者（DTC）的广告。1997年，美国食品药品监督管理局（FDA）发布了一份关于此类大众媒体推广的“指南”。该指南改变了FDA的现有规定，并实际上允许制药公司在电视和广播上推广处方药，而无需提供有关适应症、疗效或潜在不良反应的详细甚至概要信息。从那时起，特别是电视广告以及消费杂志和报纸上的印刷广告迅速激增。制药公司在1999年在DTC广告上花费了18亿美元，比1998年增长了40%。1999年的这笔支出主要集中在大约50种药物上。越来越多的证据表明，处方药的DTC推广正在：（i）提醒消费者注意新药的存在及其所治疗的病症；（ii）增加消费者对许多药物的需求；（iii）越来越多地导致最近配药处方数量的急剧增加；（iv）提高销售收入；因此，（v）导致健康保险公司、政府和消费者的药品成本上升。围绕DTC广告的公共政策问题集中在以下问题上：（i）广告是否导致某些药物的不当临床使用？（ii）广告是否诱使消费者和医生选择更昂贵的新品牌药物，而不是更便宜但同样有效的旧品牌或仿制药？（iii）处方药的电视广告是否包含关于益处与潜在不良反应的平衡信息量？以及（iv）DTC广告产生的收入效益是否会导致制药公司更专注于开发治疗常见但不危及生命的病症的产品，如脱发、性功能障碍或记忆力减退？尽管处方药支出、保险覆盖范围和支付政策已成为美国的主要政治问题，但这些问题才刚刚开始被探讨。
