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Advertising complaints department

A new office to deal with complaints from doctors and the public about direct-to-consumer advertising will be set up in the US

Pharmaceutical companies in the US are establishing an office to review complaints from the medical profession and consumers about the marketing of prescription drugs.

The Pharmaceutical Research and Manufacturers of America (PhRMA) is setting up the Office of Accountability to 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.

One point in 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.

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.

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.

Pharma companies and regulators had hoped that the Guiding Principles, one of which asks that the FDA approves all new DTC campaigns for broadcast and print media before they are released to the public, would appease critics and stem the growing consumer backlash. Yet, many still believe that regulators are not exerting enough pressure on companies to responsibly communicate product information to the public.

Sidney Wolfe, director of Public Citizen's Health Research Group, has dismissed PhRMA's move, describing the voluntary code as a ìmeaningless attempt to fool people into believing the guidelines are stronger than they really areî.

Wolfe has urged regulators to enforce guidelines pertaining to the accuracy and balance of DTC campaigns more stringently and said they should have the power to fine a pharmaceutical company that violated the new guidelines.

2nd September 2008

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