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

August 02, 2005


In a major policy speech before the American Legislative Exchange Council’s 32nd Annual Meeting this evening, PhRMA President and CEO Billy Tauzin will announce the pharmaceutical industry’s “Guiding Principles” on direct-to-consumer advertising.

“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,” said Tauzin.

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.

“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,” said William C. Weldon, Chairman and CEO of Johnson & Johnson and PhRMA’s board chairman.  “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.”

“These principles will help us do a better job in working with patients,” said Karen Katen, Pfizer vice chairman and president of Pfizer Human Health, who also chairs PhRMA’s Group on Affordability and Access.  “Through the principles, we can improve communications about pharmaceutical risks and benefits, educate the public about prescription medicines and treatment options, enhance health awareness and motivate patients to talk with their health care providers about their health.”

As part of the new Guiding Principles, which exceed current FDA regulations in many ways, PhRMA will establish an “Office of Accountability.” It will be responsible for receiving comments from the general public and health care professionals regarding direct-to-consumer advertising done by companies that adopt these principles.

“The PhRMA Office of Accountability will issue periodic reports to the public regarding the nature of the comments and the signatory companies’ responses, and it will provide a copy of each report to the FDA,” said Tauzin.

One year after the principles go into effect, Tauzin added, the Office of Accountability will select an independent panel to review reports for that year, track the overall trends as they relate to the principles, and make recommendations in accordance with the principles. The panel’s report will be made public.

"We believe this latest action is another step forward in developing healthcare communications that are appropriate in a very fast-changing and complex environment," said Fred Hassan, chairman and chief executive officer, Schering-Plough Corporation. "We believe that by doing what is right for the patient, we will continue to build common ground in this important area."

“We applaud the development of guiding principles by the industry," said Peter R. Dolan, chief executive officer, Bristol-Myers Squibb Company, and PhRMA chairman-elect.  "This is a significant step in the right direction.  I am pleased that we have joined together to reaffirm our commitment to appropriately and accurately communicate important information about prescription medicines."

“We believe in the value of DTC advertising in improving consumer awareness of diseases, conditions, and the availability of treatment options that may improve health and the quality of lives,” said Richard T. Clark, chief executive officer and president, Merck & Co., Inc.   “We support the Principles and believe they can further enhance the ability of DTC advertising to help consumers achieve better health outcomes.”

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

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.