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FDA issues rule on direct-to-consumer drug ads
Posted
8-16-99 Washington. Final rules from the Food and Drug Administration on direct-to-consumer (DTC) marketing give specific directions to manufacturers about disclosing risks. The rules are similar to a draft guidance released in August 1997. Until then, the FDA had not given pharmaceutical companies a practical approach to broadcast advertising for prescription drugs, which meant that advertisements often didn't accurately represent the product, said Nancy Ostrove, branch chief of the FDA's division of drug marketing, advertising, and communication. The final rules help consumers because broadcast advertisements now "give the other side of the story; that is, the risks," Ostrove said. In addition to having to disclose the risks of the drug, pharmaceutical companies must provide at least four ways patients can get additional information about a product. They can refer people to a toll-free telephone number, a healthcare provider, an Internet address, a current print ad, or alternately, a product brochure. The approach ensures that DTC advertisements will meet the needs of a diverse audience, according to the FDA. DTC advertising has been controversial, said Jeff Trewhitt, spokesperson for Pharmaceutical Research and Manufacturers of America. Still, PhRMA is "pleased with the regulations," Trewhitt said. However, Marie-Eileen Onieal, NP, RN, president of the American Academy of Nurse Practitioners, said a major concern is that DTC advertisements do not clearly represent who has prescriptive authority. "It is a misrepresentation that only physicians prescribe," Onieal added, since there are nurse practitioners prescribing nationwide.
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