The Tip of the Iceberg of Misleading Online Advertising; Comment on “Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: A Content Analysis of FDA Warning Letters”

Mintzes, Barbara

doi:10.15171/ijhpm.2016.19

The Tip of the Iceberg of Misleading Online Advertising; Comment on “Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: A Content Analysis of FDA Warning Letters”

Document Type : Commentary

Author

Barbara Mintzes

Charles Perkins Centre and Faculty of Pharmacy, The University of Sydney, Sydney, NSW, Australia

10.15171/ijhpm.2016.19

Abstract

Kim’s overview of Food and Drug Administration (FDA) regulatory actions from 2005 to 2014 is a comprehensive analysis of the US regulatory experience with online direct-to-consumer advertising (DTCA) of prescription medicines. This experience is of relevance internationally as online DTCA reaches the English-speaking public globally, despite the illegality of DTCA in most countries. The most common violations were omissions or minimizations of risk information, overstatements of efficacy, unsubstantiated claims, and promotion of unapproved (“off-label”) use. Nearly one fourth of violations involved cancer drugs, raising additional concerns about patient vulnerability, limited treatment advance, and high costs. Based on content analyses of online DTCA, these cases likely reflect a small proportion of unbalanced and misleading promotional information available on the web. The FDA is only able to review a small proportion of promotional materials submitted to them, due to limited staffing, and the delay between first posting and regulatory action means that many people may be exposed to messages that are found to be inaccurate and misleading. The sheer volume of online DTCA, combined with the ability for content to shift continually,
poses unique regulatory challenges.

Keywords

Direct-to-Consumer Advertising (DTCA)

Online Promotion of Prescription Drugs

Food and Drug Administration (FDA)

Medication Safety

Subjects

Health Policy Analysis

Mintzes B. Advertising of prescription-only medicines to the public: does evidence of benefit counterbalance harm? Annu Rev Public Health. 2012;33:259-277. doi:10.1146/annurev-publhealth-031811-124540
Topol EJ. Failing the public health--rofecoxib, Merck, and the FDA. N Engl J Med. 2004;351(17):1707-1709.
American Medical Association (AMA). AMA calls for a ban on Direct to Consumer Advertising of Prescription Drugs and Medical Devices. http://www.ama-assn.org/ama/pub/news/news/2015/2015-11-17-ban-consumer-prescription-drug-advertising.page. Accessed December 20, 2015. Published November 17, 2015.
Kim H. Trouble spots in online direct-to-consumer prescription drug promotion: a content analysis of FDA warning letters. Int J Health Policy Manag. 2015;4(12):813-821. doi:10.15171/ijhpm.2015.157
Hoy MG, Park JS. Principles in action: an examination of Food and Drug Administration letters involving violative internet promotions from 1997 to 2012. J Public Policy Market 2014;33(2):127-142.
Liang BA, Mackey TK. Prevalence and Global Health implications of social media in direct-to-consumer drug advertising. J Med Internet Res 2011;13(3):e64. doi:10.2196/jmir.1775
Egilman D, Druar NM. Spin your science into gold: direct to consumer marketing within social media platforms. Work. 2012;41:4494-4502. doi:10.3233/WOR-2012-0751-4494
Light DW, Lexchin J. Why do cancer drugs get such an easy ride? Rushed approvals result in a poor deal both for patients and cancer research. BMJ. 2015;350:h2068.
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM166244.pdf. Accessed December 20, 2015.
FDA News Release. FDA Adds Boxed Warning for Heart-related Risks to Anti-Diabetes Drug Avandia. Agency says drug to remain on market, while safety assessment continues. FDA News Release. November 14, 2007. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm109026.htm.Accessed December 20, 2015.
Cohen D. Rosiglitazone: what went wrong? BMJ. 2010;341:c4848. doi:10.1136/bmj.c4848
Ventola CL. Direct-to-consumer advertising: therapeutic or toxic? P T. 2011;36(10):669-684.
Blackburn W. Google shakes up Pharma Advertising – say goodbye to black box ads, vanity urls and Flash. PM360. The Essential resource for pharma marketing. Panorama. https://www.pm360online.com/google-shakes-up-pharma-advertising-say-goodbye-to-black-box-ads-vanity-urls-and-flash/. Published July 22, 2015.
US Food and Drug Administration (FDA). Keeping Drug Information Honest and Balanced. FDA Consumer Health Information. http://www.fda.gov/downloads/ForConsumers/ConsumerUpdates/UCM355368.pdf. Accessed December 2015. Published June 2013.
Crosse M. Prescription Drugs. Trends in FDA’s oversight of direct-to-consumer advertising. US General Accounting Office. http://www.gao.gov/new.items/d08758t.pdf. Published May 8, 2008.
http://www.fda.gov/downloads/Drugs/.../Guidances/UCM295554.pdf. Accessed December 20, 2015.
Huh J, Cude BJ. Is the information ‘fair and balanced’ in direct-to-consumer prescription web sites? J Health Commun. 2004;9(6):529-540
Sheehan KB. Direct-to-consumer (DTC) branded drug web sites risk presentations and implications for public policy. J Advert. 2007;36:123-135.
Fox S, Jones S. The social life of health information. Pew Research Center. http://www.pewinternet.org/2009/06/11/prescription-or-over-the-counter-drugs/. Published June 11, 2009.
Law MR, Mintzes B, Morgan SG. The sources and popularity of online drug information: an analysis of top search engine results and web page views. Ann Pharmacother. 2011;45(3):350-356. doi:10.1345/aph.1P572
Ricketts C. Google search adds medication info. Venturebeat website. http://venturebeat.com/2010/06/22/google-health-search-adds-drug-info-upping-pharma-ad-spend/. Published June 22, 2010.
US Department of Health and Human Services. Food and Drug Administration. DDMAC. Guidance for Industry: Consumer-Directed Broadcast Advertisements. http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm125064.pdf. Published August 1999.
Institute of Medicine. The future of drug safety: promoting and protecting the health of the public. National Academies Press; 2007.
Morris L, Banks D. New issues in drug advertising and labeling: the five advertising end-runs. Drug Information Journal. 1990;24:639-646.