Cowden A L, Katz K A
Department of Dermatology, University of Pennsylvania School of Medicine, 3600 Spruce Street, 2 Maloney, Philadelphia, PA 19104, USA.
Br J Dermatol. 2006 May;154(5):950-8. doi: 10.1111/j.1365-2133.2006.07168.x.
Spending on advertising of prescription medicines in the U.S.A. is increasing by nearly a billion dollars yearly. The Food and Drug Administration (FDA) is legally mandated to regulate pharmaceutical advertising in the U.S.A. Prior studies have documented inaccuracies in pharmaceutical advertisements, in the U.S.A. and the rest of the world.
To assess trends in FDA surveillance of dermatology-related prescription drug advertising, and to investigate pharmaceutical companies' responses to FDA regulatory actions.
We analysed all FDA citations of prescription drug advertisements issued during 2000-2003, and responses from cited companies to our mailed requests for follow-up information.
Twenty-four dermatology-related drugs from 21 companies accounted for 30 (15.2%) of the 198 letters sent by the FDA; of these, 18 letters cited advertisements or promotions of these medications for dermatology-related uses. The most common violation cited overall was insufficient communication of risk (32.4% overall, 33.9% dermatology-related). Most FDA letters cited physician-targeted advertising (71.6% overall, 62.1% dermatology-related). The number of dermatology-related letters sent declined by 69.2% from 2000 (n=13) to 2003 (n=4), paralleling the 69.6% decline in the total number of letters sent (n=79 in 2000, n=24 in 2003). Compared with 2000, the FDA took longer to issue citation letters in 2003 for advertisements overall [hazard ratio (HR) 0.47, 95% confidence interval (CI) 0.27-0.72, P=0.001], although this trend was not present for dermatology-related advertisements (HR 1.12, 95% CI 0.39-3.29, P=0.83). Eight of the 16 companies (50%) that received requests from the authors for information replied. Seven of the eight (87.5%) reported complying with FDA requests to discontinue the cited advertisements, while one (12.5%) reported disagreeing with the citation and successfully clarifying the issue with the FDA.
Dermatology-related advertisements accounted for 15.2% of FDA citations of pharmaceutical advertisements between 2000 and 2003. Recent controversy over pharmaceutical advertising may lead to changes in pharmaceutical advertising practices and surveillance of pharmaceutical advertising in the U.S.A.
美国处方药广告支出每年增长近十亿美元。美国食品药品监督管理局（FDA）依法负责监管美国的药品广告。此前的研究已记录了美国及世界其他地区药品广告存在的不准确之处。
评估FDA对皮肤科相关处方药广告监管的趋势，并调查制药公司对FDA监管行动的反应。
我们分析了2000 - 2003年期间FDA发布的所有处方药广告引用文件，以及被引用公司对我们邮寄的后续信息请求的回复。
来自21家公司的24种皮肤科相关药物占FDA发出的198封信函中的30封（15.2%）；其中，18封信函引用了这些药物用于皮肤科相关用途的广告或促销活动。总体上最常见的违规行为是风险信息传达不足（总体为32.4%，皮肤科相关为33.9%）。大多数FDA信函引用了针对医生的广告（总体为71.6%，皮肤科相关为62.1%）。从2000年（n = 13）到2003年（n = 4），发出的皮肤科相关信函数量下降了69.2%，与发出信函总数下降69.6%（2000年n = 79，2003年n = 24）相平行。与2000年相比，2003年FDA发布广告引用信函的时间更长[风险比（HR）0.47，95%置信区间（CI）0.27 - 0.72，P = 0.001]，尽管这种趋势在皮肤科相关广告中不存在（HR 1.12，95% CI 0.39 - 3.29，P = 0.83）。收到作者信息请求的16家公司中有8家（50%）回复。这8家公司中有7家（87.5%）报告遵守了FDA停止所引用广告的要求，而1家（12.5%）报告不同意引用，并与FDA成功澄清了问题。
2000年至2003年期间，皮肤科相关广告占FDA药品广告引用的15.2%。近期关于药品广告的争议可能会导致美国药品广告做法及药品广告监管的变化。
