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The agency announced proposed research studies on how healthcare providers and patients understand drug promotional materials.
On March 12, 2018, FDA announced it was proposing research studies to be conducted by the Office of Prescription Drug Promotion to gain information on how risk and benefit information is understood by healthcare providers and patients. This research will be used to help the agency develop guidelines on disclosure of risk information in advertising.
FDA also published a notice in the Federal Registerabout the purpose and role of social science in prescription drug promotion policy. A proposed study on the Utilization of Adequate Provision among Low to Non-Internet Users 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,” according to the agency.
"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, MD, in a press release. “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."