FDA-led study highlights tradeoffs in drug promotion on social media

Regulatory NewsRegulatory News
| 11 August 2022 | By Mary Ellen Schneider 

Providing both benefit and risk information within character-space-limited (CSL) drug promotions on social media platforms like Twitter improved recognition of risks but made it less likely that consumers would click links for additional information on the drug, according to a series of experimental studies led by the US Food and Drug Administration (FDA).
“Although it can be challenging to add risk information to CSL communications, this research supports FDA guidance on this topic and suggests that industry may want to continue innovating to find ways to include risk information in CSL communications,” Helen Sullivan, of the FDA, and colleagues wrote in the journal Research in Social and Administrative Pharmacy.
CSL drug promotion
Under current rules for prescription drug promotion, drugmakers must present a fair balance of risk and benefit information when promoting products but the agency has been wrestling with how to apply that standard to social media and Internet platforms that limit the number of characters in a communication.
In 2014, FDA issued draft guidance that advises drugmakers to include risk information in the body of the CSL communication, rather than just providing a link to the risk information. Further, the draft guidance recommended that CSL communications include a link to a landing page with risk information only (RELATED: FDA Guidance: How Can Pharma and Device Companies Use Twitter? Not Easily. Regulatory Focus 17 June 2014). However, the agency has yet to finalize the guidance and in 2016 announced plans to study the issue in four experimental studies simulating Twitter posts and Google sponsored links. (RELATED: Drug Marketing on Twitter: FDA to Study Space-Limited Communications, Regulatory Focus 7 November 2016)
Four experimental studies
The research, published online in August, includes results from four experimental studies looking at the impact of including substantive risk information in the CSL versus only providing a link to the risk information, and including both risk and benefits on the linked landing page versus only providing risk information on the landing page.
The research was divided into four experimental studies that included either participants who reported severe headache/migraine and who were exposed to a mock search page for a fictional drug on either Google or Twitter, or participants who reported trying to lose weight in the past year and were similarly exposed to fictional drug information on either a Google or Twitter mock search page. Each of the four studies included 469 participants.
Overall, including the substantive risk information within the CSL communication significantly increased the chance that participants would recognize the risks after the first viewing (shown in three studies) and after the second viewing (shown in all four studies).
At the same time, after a second viewing of the CSL communication that included substantive risk information, participants were significantly less likely to click the link to the landing page. In three studies, having substantive risk information in the CSL communication also significantly decreased the number of landing-page-only risks that were recognized. “Including some risk information in the CSL communication may lead individuals to assume they do not need to switch their attention to the link,” the researchers wrote.
Adding drug benefit information to the landing page made it significantly more likely that participants would recognize the drug’s benefit after a second viewing (shown in all four studies). However, one study found that including benefits on the landing significantly decreased risk perceptions, as well as the number of landing-page-only risks that were recognized by participants after the second viewing.
“In three of the four studies, including benefit information on the landing page did not negatively affect participants’ recognition or perceptions of the risk. This suggest that the landing page may not need to focus exclusively on risk,” the researchers wrote. “However, it is noted that the risk information on the landing page in this study was presented with equal prominence as the benefit information; landing pages that emphasize benefits over risks may lead to different outcomes.”
One of the limitations of the study, the researchers noted, was that they used fictional drugs for the studies, which meant they could create risk information that could be summarized in a CSL communication, unlike with many real-world drugs.
The research was funded by the FDA Office of Prescription Drug Promotion.
Research in Social and Administrative Pharmacy study


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