+ Site Statistics
+ Search Articles
+ PDF Full Text Service
How our service works
Request PDF Full Text
+ Follow Us
Follow on Facebook
Follow on Twitter
Follow on LinkedIn
+ Subscribe to Site Feeds
Most Shared
PDF Full Text
+ Translate
+ Recently Requested

Regulation of prescription drug promotion: direct-to-consumer advertising



Regulation of prescription drug promotion: direct-to-consumer advertising



Clinical Therapeutics 20 Suppl C: C86-C95



The US Food and Drug Administration (FDA) is responsible for regulating the information on prescription drugs disseminated by sponsors to health care providers and consumers to ensure that it is truthful and not misleading, and that it presents a fair balance of benefit and risk information. Thus the public health is both protected and promoted by the dissemination of honest, accurate information about regulated products. This paper discusses the regulatory requirements for promotional materials for prescription drugs and the standards used by the FDA to evaluate these materials. It also discusses the agency's views on direct-to-consumer advertising, the enforcement actions that are available to the FDA, the process used by the FDA to determine what action should be taken and when, and what remedies are available.

Please choose payment method:






(PDF emailed within 1 workday: $29.90)

Accession: 047214595

Download citation: RISBibTeXText

PMID: 9915094


Related references

The development of direct-to-consumer prescription drug advertising regulation. Food and Drug Law Journal 57(3): 423-443, 2002

Direct-to-consumer prescription drug advertising: history, regulation, and issues. Minnesota Medicine 93(3): 50-52, 2010

Prescription drug coupons: evolution and need for regulation in direct-to-consumer advertising. Research in Social and Administrative Pharmacy 10(3): 588-594, 2014

The association of consumer cost-sharing and direct-to-consumer advertising with prescription drug use. Research in Social and Administrative Pharmacy 1(2): 139-157, 2005

Consumer reaction to a direct-to-consumer prescription drug advertising campaign. Journal of Health Care Marketing 8(2): 66-69, 1988

The rise and fall of celebrity promotion of prescription products in direct-to-consumer advertising. Pharmacy in History 52(1): 13-23, 2010

Effects of comparative claims in prescription drug direct-to-consumer advertising on consumer perceptions and recall. Social Science and Medicine 120: 1-11, 2014

Consumer tradeoff of advertising claim versus efficacy information in direct-to-consumer prescription drug ads. Research in Social and Administrative Pharmacy 15(12): 1484-1488, 2019

Direct-to-consumer ads can influence behavior. Advertising increases consumer knowledge and prescription drug requests. Marketing Health Services 18(2): 26-32, 1998

Direct-to-consumer prescription drug advertising. AmericanJournalofHealth-SystemPharmacy54(19):2181, 1997

Direct-to-consumer prescription drug advertising. Medical Care 35(1): 86-92, 1997

Direct-to-consumer prescription drug advertising and the public. Journal of General Internal Medicine 14(11): 651-657, 1999

An Rx for direct-to-consumer advertising of prescription drug products. Journal of Hospital Marketing 4(1): 143-152, 1990

Does direct-to-consumer prescription drug advertising do more harm than good?. Annals of Internal Medicine 151(11): 823, 2009

The educational potential of direct-to-consumer prescription drug advertising. Health Affairs 23(4): 143-150, 2004