Don’t You Forget About Me: OPDP Untitled Letter Signals Continued Scrutiny of HCP-Directed Promotional Claims

Key Takeaways

• The Food and Drug Administration’s Office of Prescription Drug Promotion’s (“OPDP”) enforcement extends beyond direct-to-consumer (“DTC”) advertising: the agency issued an Untitled Letter to a drug company for misleading claims made on its healthcare professional (“HCP”)-directed website.
• The Letter identified significant limitations in the underlying data, including reliance on an open-label, single-arm trial and post hoc analyses, that could not support the efficacy, benefit on patient-reported outcome, and quality-of-life claims made in the promotional materials.
• Companies should ensure that internal review committees (e.g., Promotional Review Committees (“PRCs”)) rigorously test whether underlying data supports proposed claims, and that any qualifiers used to support a claim are prominent rather than buried in a footnote or on a back page.

Understandably, FDA renewed enforcement against unlawful DTC promotion for prescription drug products has received the headlines and AGG bulletin attention. However, OPDP seems to be singing Simple Minds’ 1985 song “Don’t You (Forget About Me)” as it continues to take enforcement action against misleading promotion targeting HCPs with its most recent Untitled Letter. This comes less than a month after OPDP issued a separate Untitled Letter to a company regarding HCP-directed emails, as outlined by AGG here.

What FDA’s OPDP Cited in Its Latest Untitled Letter

• The company presented efficacy and patient-reported outcomes (“PRO”) data based on an open-label, single-arm trial, a post hoc analysis of one trial, and a post hoc analysis of another trial in conjunction with “attention-grabbing, colorful, bold graphics and charts with large font” that OPDP found to create a misleading impression regarding the product.
• OPDP found “several significant limitations to the cited references that preclude the drawing of conclusory claims regarding the benefits of [the drug product].”
• The agency acknowledged that a qualifier “post hoc analysis” was included “as a less prominent footnote… this does not mitigate the misleading impression.”
• OPDP questioned claims relating to benefit on PRO and Health-Related Quality of Life for several reasons, including that the trial was an open-label, single-arm trial that “did not establish that any of the PRO outcomes seen were attributable to effect of the drug.” Because OPDP found that the PRO data from the trial had limitations and biases, the claims made based on these data were not supported and were, therefore, misleading.

What Pharmaceutical Companies Should Do Now

• While OPDP enforcement in the DTC space is certainly on the rise, companies must remember that HCP-facing promotion is also subject to OPDP review.
• Companies’ internal review committees, such as PRCs or Medical, Legal, and Regulatory committees, must carefully review the references and studies used to support claims to confirm that the studies actually support those claims.
• Qualifiers may make the presentation of data more accurate and transparent, but they must be prominent (e.g., close in space to the claim and not buried in a footnote or back page); if there are no qualifiers that can save the claim, or the underlying data is simply not substantial or clinically significant, companies must consider not making the claim at all.

Once again, OPDP is providing a reminder that its enforcement extends beyond DTC advertising to HCP-directed promotional materials. As Simple Minds urged in “Don’t You (Forget About Me),” companies should not forget that HCP promotion is on OPDP’s radar, not only DTC pieces.

For guidance on these issues, please contact a member of AGG’s Food & Drug team.