FDA Sets New Rules For Radio/TV Pharma Ads

Responding to criticism that advertising of medicines on television andradio is misleading, the US Food and Drug Administration has issued a proposed guidance that will clarify the requirements for prescription drug advertisements, making them more understandable to consumers.

The new rules would allow drugmakers to say what a drug does in an ad, so long as they also describe its major risks and make adequate provisions for patients to get the rest of the information, according to the FDA's Robert Temple. Adequate provisions would include offering a toll-free telephone number for consumers to access detailed product information in a timely fashion - by mail, fax or phone.

According to a statement from the Department of Health and Human Services, this new approach presumes that the broadcast ad is truthful, not misleading and contains information about the major health risks associated with the drug. Under the current federal Food, Drug and Cosmetics Act, advertisements for prescription drugs must contain a "brief summary" of all important information about the advertised drug, including side effects, contraindications and effectiveness.