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BY OUR PHARMA CORRESPONDENT
July 30, 2005: The Pharmaceutical Researchers and Manufacturers of America (PhRMA) has responded to the growing backlash against direct-to-consumer (DTC) advertising by developing comprehensive voluntary guidelines that would ensure that ads are more educational and balanced.
The Guiding Principles, which go beyond current Food and Drug Administration (FDA) regulations, encourage companies to discuss new medicines with doctors before launching an advertising campaign aimed at consumers, to promote health and disease awareness within the campaign, and to tailor their advertising to appropriate audiences and age groups.
Pharmaceutical and healthcare ads aimed at consumers 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 labelling, the Guiding Principles state.
DTC has come under fierce attack in recent weeks with continued criticism from patients, doctors and policy makers, including influential Tennessee Republican Bill Frist, for its role in fuelling the skyrocketing costs of prescription drugs.
Earlier this month, Frist recommended to Congress that pharmaceutical companies should restrict DTC advertising during the first two years of a product's launch and called for an investigation into the way in which the FDA oversees DTC ads, the pharma industry's spending on such advertising activity, and the effect advertising has on healthcare costs and patient education levels.
However, PhRMA president and CEO, Billy Tauzin said that he believed DTC has a very important place in educating the American public about healthcare and diseases.
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, Tauzin said.
Yet, despite the moves by the PhRMA and its member companies, consumer groups are not satisfied that the Guiding Principles will make any real difference to the way pharma companies approach DTC.
Rob Schneider, director of Consumers' Union prescription drug reform initiative, www.prescriptionforchange.org, commented: It appears the pharmaceutical industry has produced a placebo rather than supporting real reform of drug advertising.
Much of what the industry is proposing is already law, such as producing ads that aren't misleading. What we clearly need is more authority and resources to ensure that all marketing, not just the amount spent on direct-to-consumer advertising, is honest and accurate, he added.
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