News & Events

FDA In Brief: FDA unveils research plan to inform policy, enforcement work related to prescription drug promotion

For Immediate Release: Mar. 12, 2018

Media Inquiries

  Stephanie Caccomo

"The FDA has prioritized a robust social and behavioral science research program to help us understand how people make decisions about the products we regulate. This includes research surrounding how patients and health care providers understand prescription drug benefit and risk information in promotional materials. This research has provided key information to inform our policies related to the proper regulation of prescription drug advertising,” said FDA Commissioner Scott Gottlieb, M.D. “Most recently, our research on how drug risks are presented in TV ads suggested that a more targeted presentation of risks may lead to better retention of the potential side effects that consumers should weigh as they consider their treatment decisions. As a result, we’ve been exploring new guidelines that would recommend more focused disclosure of risk information in TV ads, to better emphasize potential side effects that are severe, serious and actionable. I’m committed to continuing to invest in this critical research to help ensure we’re making informed, science-based decisions. To achieve these goals, we recently announced several additional research projects that can help us understand other important aspects of promotional communications. This includes the effectiveness of disclosures, communications aimed at health care providers and consumer understanding of the accelerated drug approval process."

The U.S. Food and Drug Administration is announcing upcoming proposed research studies under the Office of Prescription Drug Promotion’s social science research program, which provides scientific evidence to help ensure that the agency’s policies related to prescription drug promotion will have the greatest benefit to public health.

Additionally, the FDA provided an overview about the purpose and role of social science in prescription drug promotion policy in a Federal Register notice related to a new, proposed study on the Utilization of Adequate Provision among Low to Non-Internet Users. This study will evaluate methods for how certain consumers can gain access to the full approved drug package labeling to help ensure that they are well-informed about a drug’s risks and benefits.

The FDA has consistently conducted research to evaluate the aspects of prescription drug promotion that are most central to the agency’s mission. This research has focused on three main topic areas. They include advertising features, including content and format; target populations; and research quality. For example, through the evaluation of advertising features, the FDA assesses how elements such as graphics, format and disease and product characteristics impact the communication and understanding of prescription drug risks and benefits.

Because the agency recognizes that the strength of data and the confidence in the robust nature of the findings is improved through multiple converging studies, the FDA continues to develop evidence to inform its thinking. The agency evaluates the results from studies within the broader context of research and findings from other sources. This larger body of knowledge collectively informs FDA policies as well as research programs.

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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.

Page Last Updated: 03/12/2018
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