Drugs

FDA Keeping Close Eye on Social Media Promotion

CDER’s Office of Prescription Drug Promotion (OPDP) says it is monitoring very closely the increasing use of social media platforms that promote prescription drugs. “The FDA takes its responsibilities seriously and will continue to monitor promotion and communications regarding prescription drugs through its surveillance operations, which include online platforms,” a CDER spokesman told FDA Webview 3/23 in response to our inquiry into recent research calling for regulators like FDA and the Federal Trade Commission to do more to keep up with social media patient influencers (see earlier story).

Study authors conclude that social media patient influencers “act as a form of interactive direct-to-consumer advertising, sharing their knowledge and experiences on pharmaceutical drugs with communities of followers in which they wield great influence. This raises ethical questions that need more investigation.” Health and digital literacy are “both concerningly low in this country,” the study author says, noting that consumers often fail to recognize the difference between a sponsored ad and an altruistic personal post. “The fact that patients with no medical training are broadly sharing drug information should alarm us,” she concludes.

“The FDA understands that today, various social media platforms increasingly enable prescription drug manufacturers, packers, distributors, and their representatives to more actively engage with consumers and healthcare professionals about the products they manufacture and market,” the CDER spokesman says. “As with promotional labeling and advertising generally, when manufacturers, packers, distributors, or their representatives promote their prescription drugs to consumers and health care providers using social media platforms, FDA’s statute and regulations require that such communication be truthful, non-misleading and balanced. We note that FDA’s draft guidances for social media recommend that, regardless of the platform, manufacturers, packers, distributors, or their representatives that choose to present benefit information should present both benefit and risk information to best serve the public health.”

OPDP also encourages anyone who has concerns about potentially false or misleading prescription drug promotion to report it for further investigation through The Bad Ad Program.

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome