The head of one of the nation's most powerful pharmaceutical associations announced tighter internal controls, highlighted by a program called "Guiding Principles" regarding consumer advertising would avoid the need for government intervention in this increasingly contentious area.
Pharmaceutical Research Manufacturers of America (PhRMA) President and CEO Billy Tauzin announced the program in an August 2 speech in Washington, D.C. Among its requirements are:
Companies should submit all new direct-to-consumer television advertisements to the FDA before releasing them for broadcast.
- 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.
Other provisions, such as educating healthcare workers, were also included in the guidelines,which were enthusiastically endorsed by major pharmaceutical companies.
“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.
His comments were echoed by other leaders such as Karen Katen, Pfizer vice chairman and president of Pfizer Human Health, who said, "“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.”
The plan Tauzin announced also calls for an "Office of Accountability" that will issue reports to the public and make annual recommendations.
Some consumer advocates have singled out Tauzin's rhetoric on this issue. Within days, advocates such as Gary Ruskin of Commercial Alert had criticized the lobbyist, calling his comments on the topic "ironic".
Politicians are taking notice. The Washington Post announced that Senate Majority Leader Bill Frist (R-Tenn.) has called for a government study of the issue by the U.S. Government Accountabiity Office while the United States Food and Drug Administration reaffirmed that consumer advertising was one of its key initiatives. The government agency went far beyond the industry's own pledge of self-policing by stating that it would:
- Develop draft guidance on a scientific evidence-based rating system for qualified health claims for conventional foods and supplements.
- Expand efforts, in conjunction with the Federal Trade Commission (FTC), to take action against unsubstantiated claims on dietary supplements through warning letters, seizures, and/or injunctions against misbranded products.
- Develop guidance for industry on the content of the "brief summary" for direct-to-consumer advertising.
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