美国面向消费者处方药广告的监管机制研究

打开文本图片集

中图分类号R95 文献标志码A 文章编号 1001-0408（2025）22-2760-06

DOI 10.6039/j.issn.1001-0408.2025.22.02

ABSTRACTOBJECTIVEToexplore theregulatoryframework fordirect-to-consumer（DTC）prescriptiondrugadvertising in the UnitedStates，inordertoprovidereferencefortheimprovementofChina’spharmaceuticaladvertisingregulatorysystem. METHODSByutilizingthe literatureresearchapproach，thisstudysystematicallyanalyzedtheFederalFood，Drug，and Cosmetic Act，along withrelevantregulatoryguidelines.Itsregulatory framework andenforcement mechanisms grounded inthe principleofrisk-benefitbalancewereelucidated.RESULTSTheFDAhadestablishedadual-trackregulatoryapproachthat combinedcategorizedsupervisionwithstringentpost-marketaccountability.Inthepre-marketphase，DTCprescriptiodrug advertisementswereclasifiedintothreecategories，ie.productclaimadvertisements，reminderadvertisements，andhelp-seeking advertisements，basedontheextentofinformationdisclosure.Diferentiatedstandardswereimplementedtobalanceinformation diseminationandiskcontrol.Inthepost-marketphase，amulti-facetedliabilitysystem wasestablished，combiningsubstantial civilfines，administrativecorectivemeasures，andriminalprosecutiontoeffectivelydeterillgaladvertisingpractices. CONCLUSIONSTheregulatory mechanismfor DTCprescriptiondrugadvertisinginthe United StatesofersValuableexperience inbalancingcommercialfreedomandpublichealth.Chinacandrawonitsrisk-balancerationalebyintegratingtheflexibilityof categorizedsuperisionwiththerigidityofamulti-facetedliablitysysteminitslegislationaimingtosafeguardpublicedication safetywhile promoting the healthy development of the pharmaceutical market.

KEYWORDS prescription drug advertising;regulatory mechanism； direct-to-consumer advertising

面向消费者（direct-to-consumer，DTC）的处方药广告是指制药企业绕过医疗专业人员，通过电视、网络、社交媒体及报刊等媒介向普通消费者推销处方药的广告形式。（剩余12488字）