As FDA considers new guidelines on pharmaceutical product marketing, a new study found that pharma makers may not be following current FDA ad regulations.
As FDA considers new guidelines on pharmaceutical marketing, a recent study found that pharma makers may not be following current FDA ad regulations.
None of the television drug ads included in the study, published in the February 26 issue of the General Journal of Internal Medicine, described the drugs’ risks quantitatively. In addition, 13% of the ads-all for diabetes medications-suggested off-label uses for weight loss and blood pressure reductions, according to the authors.
“Few broadcast DTC [direct-to-consumer] ads were fully compliant with FDA guidelines,” the authors wrote. “The overall quality of information provided in ads was low, and suggestions of off-label promotion were common for diabetes medications.”
Meanwhile, FDA prioritized a “robust social and behavioral science research program to help us understand how people make decisions about the products we regulate,” said FDA Commissioner Scott Gottlieb, MD, in a statement.
“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,” Gottlieb said. “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.”
Several research projects from FDA will help the agency understand the effectiveness of disclosures, “communications aimed at health care providers and consumer understanding of the accelerated drug approval process,” Gottlieb said.
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