October 16, 2018
“We’re committed to ensuring that prescription drug promotional materials, including direct-to-consumer promotion, is truthful and non-misleading; and that important information about benefits and risks is presented in a way that’s clear, concise, useful and informative,” said FDA Commissioner Scott Gottlieb, M.D. “The draft guidance we’re issuing today provides advice on how quantitative effectiveness and risk information in consumer ads, such as the results of clinical trials, can be presented in a way that’s more easily understood by consumers. Our aim is to make sure consumers have clear information about the benefits and risks of a product.”
Today, the U.S. Food and Drug Administration issued a draft guidance to provide the agency’s recommendations for presenting quantitative efficacy and risk information in direct-to-consumer (DTC) promotional labeling and advertisements for prescription human drugs and biological products and prescription animal drugs and in DTC promotional labeling for over-the-counter animal drugs.
The draft guidance, Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements, describes the FDA’s recommendations for how manufacturers that choose to include quantitative efficacy or risk information about their drugs in DTC promotional materials can make the language and presentation more consumer-friendly. For example, when manufacturers choose to present information about clinical trial results, the agency recommends that the data be presented as absolute frequencies or percentages. As the FDA’s own research has suggested, formatting the numbers in this manner can help consumers more easily understand and remember the information. An illustrative example in the guidance of an appropriate presentation of figures is: “In a clinical trial, 78 out of 100 patients experienced a response after 12 weeks of treatment with Drug X.”
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.