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Quality Digest

FDA Compliance

PhRMA Announces Advertising Guidelines

Published: Tuesday, August 23, 2005 - 22:00

The Pharmaceutical Research and Manufacturers of America (PhRMA) recently adopted a new set of guidelines for its members’ direct-to-consumer advertising activities. PhRMA’s board of directors gave final approval to the Guiding Principles in July, but they only become effective in January 2006. The purpose of the new rules is to ensure the appropriate and standard use of DTC pharmaceutical advertising.

“By formally adopting these guidelines, we’re 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,” says William C. Weldon, chairman and CEO of Johnson & Johnson and PhRMA board chairman. “We’re 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.”

PhRMA will establish an Office of Accountability that will field comments and complaints from the public and health care professionals about DTC advertising. The office will also select an independent panel that will review reports, track trends as they relate to the new rules and make recommendations. The report will be made public.

“We believe this latest action is another step forward in developing health care communications that are appropriate in a very fast-changing and complex environment,” says Fred Hassan, Schering-Plough Corp. chairman and CEO. “We believe that by doing what is right for the patient, we will continue to build common ground in this important area.”

Key elements of the Guiding Principles include:

  • Companies should submit all new DTC 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 it.
  • DTC television and print advertising should be designed to achieve a balanced presentation of the benefits and risks associated with the advertised prescription medicine. This should be done in clear, easy-to-understand language.
  • Companies should spend an appropriate amount of time to educate health professionals about new medicines or therapeutic conditions before starting DTC campaigns.

PhRMA represents the country’s leading pharmaceutical research and biotechnology companies. For more information, visit www.phrma.org.


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