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AMA LAUNCHES NEW POLICY ON DTC ADVERTISING FOR DEVICES AND DRUGS

June 16, 2006

The American Medical Association (AMA) has announced a new policy on direct-to-consumer (DTC) advertising of implantable medical devices and prescription drugs. The new policy includes imposing a temporary moratorium on the advertising of newly approved devices and drugs, and guidelines for pharmaceutical companies to follow when preparing DTC advertising.

In addition to the moratorium on newly approved devices and drugs -- the time interval for which will be determined by FDA -- the AMA adopted additional guidelines for DTC ads. The ads should: provide objective information about device and drug benefits that reflect the true efficacy of the device or drug, as determined by clinical trials; show fair balance between the benefits and risks of the advertised devices or drugs by providing comparable time or space and cognitive accessibility, and by presenting warnings, precautions and potential adverse reactions in a clear and understandable way without distraction of content; clearly indicate that the ad is for a prescription drug and refer patients to their physicians for more information and appropriate treatment; be targeted for age-appropriate audiences; and receive pre-approval from the FDA.

The AMA also calls for additional research into the effects of DTC advertising on the patient-physician relationship, overall health outcomes and healthcare costs.