Direct to Consumer (DTC) Marketing and the Pharmaceutical Industry

1. Direct to Consumer (DTC) Marketing and the Pharmaceutical Industry Does the current state of DTC marketing cross ethical lines and boundaries?

2. Three main types of DTC Ads. • Product Claim Ads – these ads name the drug and the condition it treats, and talk briefly about its benefits and associated risks. • Reminder Ads – this type of advertisement provides the drug’s name, but doesn’t mention the drug’s uses. • Help-seeking Ads – describes a specific disease or condition, but stop short of recommending or suggesting a specific drug. Source: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm107170.htm

3. Quick Facts and Regulatory Agencies. • The United States is one of only two developed nations that currently allow DTC pharmaceutical advertising, with New Zealand being the second. • The FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC) is responsible for ensuring that all prescription drug promotion provided by drug firms is truthful, balanced, and accurately communicated. Source: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm107170.htm

4. Requirements placed upon DTC advertisers. • Product claim ads are required to provide full disclosure of a drug’s known risk information. • In print ads this information can be found near the end in a font so small its difficult for the eye to read. • TV ads are allowed the liberty to highlight only the main points so long as the location on where to obtain the complete information is disclosed to the targeted consumer. Source: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm107170.htm

5. The Ethical Dimension

6. Targeting doctors Doctors are being influenced by the perks offered by major pharmaceutical manufacturers and reps. These representatives are offering doctors free samples when they visit them and when they are not, they are sending invitations to expensive and elegant “informational” events.

7. Pharmaceutical Companies Persuade Doctors • Pharmaceutical Companies treat Doctors to extravagant dinners and all expense paid junkets for the purpose of influencing their decisions in which drugs to prescribe. This has driven the patients cost up in some cases by as much as $160 per day when prescribed the newer more expensive drugs. • Pharmaceutical Companies give Doctors all expenses paid trips, the only requisite of the Doctors is to agree to listen to several lectures detailing new market offerings by the hosting company. In a research study conducted, this type of marketing influenced Doctors choice of prescription drugs prescribed by as much as 200% Source: http://www.scu.edu/ethics/publications/submitted/morreim/prescribing.html

8. The Legal Dimension

9. Existing Legislation • In 1969, FDA issued final regulations governing drug advertising at 21 C.F.R. § 202.1.47 • Under these regulations, advertisements must have four basic attributes: • (1) - they cannot be false or misleading • (2) - they must present a “fair balance” of information about the risks and benefits of using the drug • (3) - they must contain “facts” that are “material” to the product’s advertised uses • (4) - in general, the advertisement’s “brief summary” of the drug must include every risk from the product’s approved labeling. Source: http://www.law.umaryland.edu/marshall/crsreports/crsdocuments/RL3285303252005.pdf

10. Gray Area of Compliance • From 1969 to early 1997 advertisers and drug companies relentlessly championed against the disclosure regulations. • Given the short timeframe, often 60 seconds or less, it was considered too cumbersome to include all the required information within the ads. • In regards to print ads, the space limitations posed the same drawback and deterrent. Source: http://www.law.umaryland.edu/marshall/crsreports/crsdocuments/RL3285303252005.pdf

11. The Financial / Business Dimension

12. Money Matters • According to Jon Swallen, a research analyst at TNS Media Intelligence, pharmaceutical companies spent about $4.7 billion in magazine and television advertising in 2008. • This money could be diverted to research and development of new drugs, and assist in making existing drugs more effective • However, many peoples livelihoods depend on this ad revenue. • In a period of one year (2008), magazines as a group would have lost roughly $210 million, or 0.8% of the approximately $25 billion in total ad revenue it took in for the year, had there been a moratorium on DTC print media. • Similarly, television outlets would have lost some $423 million, or 0.7% of its $60 billion in total ad revenue for the year. Source: http://www.time.com/time/business/article/0,8599,1876679,00.html

13. A Time for Change Has Arrived

14. Solutions Emerge; Finally A Clearer Picture • In 1997, the FDA issued draft guidance to advertisers and pharmaceutical companies on how to best comply with the regulations in place since 1969. • The guidance was finalized in 1999, expanded in 2004 to include print media, and outlined the following key points. • Required DTC broadcast advertisements to include the advertised products most important risks (referred to as a “major statement” by the FDA. • For print ads, a “brief summary” was now required by law to be included. Source: http://www.law.umaryland.edu/marshall/crsreports/crsdocuments/RL3285303252005.pdf

15. New Legislation • In 2007, the President signed into law the Food and Drug Administration Amendments Act. • The FDAAA gives FDA the authority to “. . . require the submission of any television advertisement for a drug . . . not later than 45 days before dissemination of the television advertisement” Source: http://www.law.umaryland.edu/marshall/crsreports/crsdocuments/RL3285303252005.pdf

16. Positive Change • Sponsors have the option of submitting any proposed prescription drug television ad to FDA for advisory review before publicly disseminating the ads. • In this way, sponsors can benefit from FDA’s input on whether or not ads are accurate, balanced, and non-misleading before they disseminate the ads. Source: http://www.law.umaryland.edu/marshall/crsreports/crsdocuments/RL3285303252005.pdf

17. Going a step further Are the regulations in place enough? Do they do enough to ensure the safety and general well being of the intended audience? Tobacco is known to be a carcinogen, but the population was once bombarded with print and media ads for these products, also regulated by the FDA.

18. Beware of Side Effects: Time to Ban Pharmaceutical Advertising • In 1970 – congress passed law ending Tobacco advertising on radio and television. • Heavily medicated public = heavy profits • Less money spent on advertising means more available funding for R & D.

19. Bibliography • FDA. "Keeping Watch Over Direct-to-Consumer Ads." FDA.gov. Food and Drug Administration, 10 May 2010. Web. 05 Nov. 2012. • Gregory, Sean. "Are Direct- To-Consumer Drug Ads Doomed?" Time.com. Time Warner, 04 Feb. 2009. Web. 05 Nov. 2012. • Morreim, E. Haavi. "Prescribing Under the Influence." Drug Company Gifts to Doctors. Santa Clara University, 2012. Web. 06 Nov. 2012. • United States of America. Congressional Research Service, The Library of Congress. Domestic Social Policy Division. Direct-to-Consumer Advertising of Prescription Drugs. By Donna U. Vogt. Washington D.C.: Congressional Research Service, 2005. Www.law.umaryland.edu. University of Maryland, 03 Mar. 2005. Web. 05 Nov. 2012.