DTC Voluntary 'Guiding Principles' Receive Preliminary Approval by PhRMA Board of Directors

DTC Voluntary ‘Guiding Principles’ Receive Preliminary Approval by PhRMA Board of Directors

July 21, 2005

 

Washington, D.C. — Listening to the concerns of consumers, physicians and other healthcare professionals, the Pharmaceutical Research and Manufacturers of America’s Board of Directors today gave preliminary approval to a set of comprehensive “Guiding Principles” on direct-to-consumer advertising of prescription medicines. 

 

“Direct-to-consumer advertising can be vitally important to patient education, increasing awareness of diseases and motivating patients to contact their physicians.  By approving these Principles, the industry is demonstrating its commitment to direct-to-consumer advertising as a way to encourage doctor-patient discussions and provide patients and consumers with accurate, accessible and timely health information,” said Billy Tauzin, president and CEO of PhRMA.

 

“With these Principles, we recognize our responsibility to make sure that direct-to-consumer advertisements live up to their potential,” said William C. Weldon, chairman and CEO of Johnson & Johnson and PhRMA board chairman.  “We want to make patients more aware of the benefits and risks of medicines and of the importance of talking to their health care providers, not only about medicines, but also about other treatment options that might help them.”

 

PhRMA and its member companies have been working for the last several months to create the Principles to ensure that direct-to-consumer advertising in the future is even more informational and educational to patients and consumers.

 

“For many Americans, advertisements can be a good source of information on prescription medicines.  Patients should have access to a wide range of health information which is especially important at a time when under-diagnosis and under-treatment of serious diseases and medical conditions afflict millions of Americans,” said Karen Katen, Pfizer vice chairman and president of Human Health, who also chairs PhRMA’s Group on Access and Affordability (GAA).

  

Some of the areas addressed by the Guiding Principles, which go beyond current FDA regulations, include:

• Conversations with physicians prior to the launch of a new direct-to-consumer campaign.  
• TV advertisements should be targeted for audience and age appropriateness.
• Companies should promote health and disease awareness as part of their advertising.
• Companies are encouraged to include information about assistance programs for the uninsured and low-income.

 

Additionally, to help achieve better consumer education, the Principles say all direct-to-consumer advertising “should be accurate and not misleading; make claims only when supported by substantial evidence; reflect balance between risks and benefits; and be consistent with FDA-approved labeling.”

 

According to Tauzin, the PhRMA Board has approved the substance of the Principles and PhRMA is working out the final details regarding some of the specific language.

 

The Principles will then go before each PhRMA member company for its consideration, voluntary adoption and implementation.

 

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 new medicines.  PhRMA companies are leading the way in the search for new cures.