The Pharmaceutical Research and Manufacturers of America (PhRMA) announced in August a new set of guidelines for direct-to-consumer advertising in the pharmaceutical industry.
“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 PhRMA President and CEO Billy Tauzin, who announced the new “Guiding Principles” at the American Legislative Exchange Council’s annual meeting in Grapevine, Texas.
The guidelines were approved by the PhRMA board of directors and 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, in a PhRMA statement announcing the rules.
Accountability Office Established
As part of the new Guiding Principles, PhRMA will establish an “Office of Accountability” responsible for receiving comments from the general public and health care professionals regarding direct-to-consumer advertising done by companies that adopt the 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 overall trends as they relate to the principles, and make recommendations in accordance with the principles. The panel’s report will be made public.
Emphasize Clarity, Completeness
Some of the key elements of the Guiding Principles are:
- 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 medicine.
- Companies should spend an appropriate amount of time educating health professionals about new medicines or new therapeutic indications before beginning the direct-to-consumer advertising campaign.
In determining what is an appropriate amount of time for educating health professionals about new medicines or therapies, the principles say 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 say.
Industry Reaction Positive
“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,” said Fred Hassan, chairman and chief executive officer of Schering-Plough Corporation, in the PhRMA statement. “We believe that by doing what is right for the patient, we will continue to build common ground in this important area.”
Pfizer announced in a news release that its future ads would be consistent with the principles.
“DTC advertising is demonstrably helpful to patients, but it should be refined to be even more helpful,” said Karen Katen, vice chairman and president of Pfizer Human Health.
“DTC ads have encouraged millions of patients to get earlier medical attention and to talk with their health care providers,” Katen said. “The problem it addresses is real: Too many Americans who need medical help postpone action, suffer unnecessarily, delay treatment until their health deteriorates, and end up suffering higher medical costs and more-acute interventions than necessary.”
Numerous Firms Signed on
In addition to Johnson & Johnson, Schering Plough, and Pfizer, 20 other firms agreed to follow the guidelines.
“Our advertising is meant to do two things. We want people to be aware of serious medical conditions and our medicines that treat those conditions, and we want to motivate them to talk to their doctors,” said Pfizer U.S. Pharmaceuticals President Pat Kelly in the company’s statement. “We believe it’s our responsibility to communicate this information effectively so patients can work with their health care providers to make informed decisions about their health and get appropriately diagnosed and treated.”
Susan Konig ([email protected]) is managing editor of Health Care News.
For more information …
The Guiding Principles can be downloaded from the PhRMA Web site at http://www.phrma.org/publications/policy/admin/2005-08-02.1194.pdf.