Regulatory news| August 11, 2022 | from
Providing benefit and risk information within space-limited (CSL) drug promotions on social media platforms such as Twitter improved recognition of risks but made consumers less likely to click on links for additional drug information, according to a series of experiments. studies led by the US Food and Drug Administration (FDA).
“While it can be challenging to add risk information to CSL communications, this research supports the FDA’s guidance on this topic and suggests that the 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 diary Research in Social and Administrative Pharmacy.
CSL drug promotion
Under current rules for promoting prescription drugs, drugmakers must present a fair balance of risk and benefit information when promoting products, but the agency has struggled with how to apply that standard to social media and online platforms that limit the number of characters in a communication.
In 2014, the FDA issued a draft guidance advising drug manufacturers to include risk information in the body of the CSL communication, rather than just providing a link to the risk information. The draft guidance further recommended that CSL communications include a link to a risk-only information landing page (RELATED: FDA Guidance: How Can Pharmaceutical and Device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 tweets and Google-sponsored links. (CONNECTED: Drug marketing on Twitter: FDA to study space-limited communicationsRegulatory focus November 7, 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 CSLs versus just providing a link to the risk information, and including risk and benefits on the associated landing page versus just providing risk information on the landing page.
The research was divided into four experimental studies involving either participants who reported severe headache/migraine and who were exposed to a search page for a fictional drug on Google or Twitter, or participants who reported trying to lose weight in the past year and were similarly exposed to fictional drug information on a mock Google or Twitter search page. Each of the four studies included 469 participants.
discovery
Overall, the inclusion of essential risk information within the CSL communication significantly increased the likelihood that participants recognized 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 essential risk information, participants were significantly less likely to click the link on the landing page. In three studies, having essential risk information in the CSL communication also significantly reduced the number of risks that were recognized only on the landing page. “The inclusion of some risk information in CSL communication may lead individuals to assume that they do not need to shift their attention to the relationship,” the researchers wrote.
Adding drug benefit information to the landing page made it much more likely that participants would recognize the drug benefit after a second viewing (shown in all four studies). However, one study found that including landing benefits significantly reduced risk perceptions, as well as the number of landing page-only risks that participants recognized after a second viewing.
“In three of the four studies, including benefits information on the landing page did not negatively affect participants’ knowledge or perception of risk. This suggests that the landing page may not need to focus exclusively on risk,” the researchers write. “However, it is notable that the risk information on the landing page in this study was presented with the same importance as the benefit information; reductions that emphasize benefits over risks may lead to different outcomes.”
One of the study’s limitations, the researchers noted, was that they used fictional study drugs, which meant they could create risk information that could be summarized in a CSL communication, unlike many real-world drugs.
The research was funded by the FDA’s Office of Prescription Drug Promotion.
Research in Social and Administrative Pharmacy survey
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