Life Science Compliance Update

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February 12, 2018

FDA Announces Study on Consumer and HCP Deception Perception

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In December 2017, the United States Food and Drug Administration (FDA) announced plans to study whether consumers and healthcare professionals have the ability to “spot and report” deceptive prescription drug promotion practices.

Reports of deceptive promotion are useful to FDA because they allow investigators to focus their efforts in an era where the amount of promotion far exceeds the resources available to review everything. The FDA Bad Ad program, for example, encourages HCPs to report deceptive prescription drug promotion, a goal which requires that HCPs successfully identify such promotion when it appears in the course of their duties. Likewise, similar programs could be implemented for consumers to report deceptive prescription drug promotion to FDA.

The FDA’s Office of Prescription Drug Promotion (OPDP) seems to be looking to the public to help it monitor deceptive drug promotion. This study would assess whether consumers and healthcare professionals (HCPs) are able to “identify claims as false or misleading, and whether they would be willing to report deceptive drug promotion to the FDA.”

The proposed project involves two studies examining volunteer participants’ ability to detect and report deceptive presentations in prescription drug promotion. The studies will be conducted concurrently and will focus on different health conditions. HCPs will view mock pharmaceutical websites targeted toward physicians while consumers will view mock consumer-targeted pharmaceutical websites. The goal will be to keep the HCP and consumer-targeted websites as similar as possible, but to include content that is appropriate for the target audience. For example, HCP websites may contain medical terminology, whereas the consumer websites would utilize consumer friendly language.

The FDA believes the ability of consumers and HCPs to identify deceptive prescription drug promotion “has important public health implications,” as consumers who are unable to spot deceptive promotions may “ask their HCPs to prescribe specific drugs that they would not otherwise request.” Additionally, if HCPs are unable to identify deceptive promotion, they “may prescribe specific drugs that they would not otherwise prescribe.”

However, OPDP notes that, “on the other hand, if consumers and HCPs are able to identify deceptive promotion, they may appropriately discount or disregard such information in their medication decisions, and perhaps even report deceptive promotion to appropriate government regulators who can take corrective action.”

Once completed, the proposed studies will provide data on whether consumers and health care professionals can identify claims as false or misleading, and whether they would be willing to report deceptive drug promotion to the FDA. Although both studies will assess consumers and health care professionals, one study will focus on the degree of deception in an ad while the second study will focus on implied versus explicitly deceptive claims.

“Promotional material that drug makers share with patients and providers can be a helpful tool for encouraging patients to seek medical care and raising awareness about new and different treatment options,” said FDA Commissioner Scott Gottlieb, M.D., in an “FDA In Brief” release. “The FDA plays an important role in helping to make sure these presentations are truthful, balanced, and nonmisleading, and we need to study promotional material to constantly improve our oversight over these activities. A key to our oversight is recognizing claims in prescription drug promotion that have the potential to deceive or mislead consumers and health care professionals.”

This most recent study is reminiscent of the aforementioned Bad Ad program that was launched in 2010 – a program that did not yield significant enforcement activity.

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