karnellKNOWLEDGE: America’s Pharmaceutical Industry Announces Guidelines on Direct-to-Consumer Advertising

December 2005

October 10, 2005

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America’s Pharmaceutical Industry Announces Guidelines on Direct-to-Consumer Advertising

Last night, in a major policy speech before the American Legislative Exchange Council’s 32nd Annual Meeting, PhRMA President and CEO Billy Tauzin announced the pharmaceutical industry’s “Guiding Principles” on direct-to-consumer advertising. The announcement comes in response to increasing criticism from congress regarding the way pharmaceutical companies are using advertising to market their drugs to consumers.

The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading pharmaceutical research and biotechnology companies, which are devoted to inventing medicines that allow patients to live longer, healthier, and more productive lives. PhRMA members alone invested an estimated $38.8 billion in 2004 in discovering and developing newmedicines. PhRMA companies are leading the way in the search for new cures. PhRMA’s Board of Directors gave final approval to the Guiding Principles on Friday, July 29, and they will go into effect in January, 2006.

Tauzin stated in a press release issued by PhRMA yesterday that “With these principles, we commit ourselves to improving the inherent educational value of advertisements. Patients need accurate and timely information and should be encouraged to discuss diseases and treatment options with their physicians. These principles will help us reach that goal."

Furthermore, William C. Weldon, Chairman and CEO of Johnson & Johnson and PhRMA’s board chairman, stated that “by formally adopting these guidelines, we are committing to the American people and the medical community that we will use advertising not only to promote new medicines, but also to educate consumers about health and disease. We are saying that we will place a balanced emphasis on the risks as well as the benefits of medicines...Good DTC advertising empowers patients to speak with their doctors and it helps them make more informed choices about their health and the medicines they take.”

The following are some of the key elements of the Guiding Principles:

Companies should submit all new direct-to-consumer television advertisements to the FDA before releasing them for broadcast.
DTC television advertising that identifies a product by name should clearly state the health conditions for which the medicine is approved and the major risks associated with the medicine being advertised.
DTC television and print advertising should be designed to achieve a balanced presentation of the benefits and risks associated with the advertised prescription medicine. Specifically, risks and safety information in DTC television advertising should be presented in clear, understandable language, without distraction from the content, and in a manner that supports the responsible dialogue between patients and health care professionals.
Companies should spend an appropriate amount of time to educate health professionals about new medicines or new therapeutic indications before beginning the first direct-to-consumer advertising campaign. In determining “an appropriate time,” companies should consider the importance of informing patients of the new medicine, the complexity of its risk-benefit profile, and health care professionals’ knowledge of the condition being treated. Companies should continue to educate health care professionals as additional valid information about a new medicine is obtained from all reliable sources.

The principles in their entirety: PhRMA Guiding Principles

Of very special note, interactive marketing was specifically exempted from the guidelines. This could be HUGE for our industry as it leaves our channel as the last remaining option for the type of targeted communications that brands need/want to do as it relates to driving consumer awareness and preference.

One pundit points out: “The guidelines only apply to TV and print advertising and not to Internet advertising. Perhaps the industry puts the Internet into a different bucket that it considers "non-advertising." Online marketing experts have already seized upon this and hope that restrictions on TV and print will mean more work for them. This remains to be seen." (source: http://pharmamkting.blogspot.com/2005/08/phrma-finalizes-dtc-principles.html)

Posted by Ian Karnell on October 10, 2005 at 09:18 PM in News Clippings | Permalink

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