BY OUR PHARMA CORRESPONDENT
12th August 2005: The Pharmaceutical Research and Manufacturers of America (PhRMA) is setting up an office to review complaints from the medical profession and consumers about marketing of prescription drugs.
The new establishment named the Office of Accountability will receive comments and complaints about direct-to-consumer (DTC) activities. The move comes under the larger umbrella of its new Guiding Principles for pharma advertising, a 15-point voluntary code aimed at tightening the promotional activities of DTC campaigns and improving the educational value of consumer ads appearing on US network television and in print publications.
The guidelines urges companies to `spend an appropriate amount of time' to educate health professionals about new medicines and new therapeutic indications before beginning the first DTC advertising campaign. However, as with a number of the remaining 14 points, the guidance stops short of enforcing a time limit for such achieving such activities.
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.
PhRMA says that being prescriptive about what constitutes an `appropriate amount of time' could lead to an unnecessary delay in patients receiving much-needed treatments.
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 a PhRMA release.
Comments made to the Office of Accountability will be issued to the public along with responses from the pharmaceutical companies responsible for the ads in question. The Office will also file a copy of each report to the Food and Drug Administration (FDA).
As part of its remit, one year on from the date the Guiding Principles come into effect (January 2006), the Office of Accountability will select an independent panel to review reports submitted in the preceding 12 months, track the overall trends and make recommendations.
PhRMA represents the country’s leading pharmaceutical research and biotechnology companies. PhRMA members alone invested an estimated $38.8 billion in discovering and developing new medicines in the year 2004.
BY OUR PHARMA CORRESPONDENT