We pay tribute in this Bulletin to the late Robbie Robertson of The Band, who penned the 1968 classic, “The Weight,” and the harmonic lyric, “You put the load right on me.”

The Food and Drug Administration’s Office of Prescription Drug Promotion issued its first Warning Letter in 2023 for unlawful promotion (following a Notice of Violation issued in June, which we summarized here).¹ Below, we summarize the OPDP’s concerns and provide our observations.

Highlights

• OPDP objected to a professional sales aid that it believed made false or misleading efficacy claims:
  • It questioned the comparative claims and the cited references that analyzed a specific trial used to support the claims.
  • OPDP said the trial “did not allow for any conclusions to be drawn” from the all-cause mortality data.
  • OPDP acknowledged a qualifier, “[t]hese results are observational in nature, and any comparisons between treatment arms should be interpreted with caution,” but said “this does not mitigate the misleading impression.”
• The agency said, “These claims and presentation are concerning from a public health perspective because they overstate the efficacy of the drug.”
• OPDP objected to the sales aid’s presentation of claims with associated p-value that implied misleading efficacy. The trial data analyzed in the cited reference did not support the claim.
  • It noted a qualifying footnote, but said this did not mitigate the misleading impression.

AGG Observations

• OPDP raised concerns from a public health perspective a few times in the Warning Letter; all bets are off if OPDP has public health concerns.
• While not likely the most egregious concern, the comparative claim, without sufficient support, did not help.
• Having studies or medical references as claim support may help minimize false or misleading allegations, but it does not mean the claim is per se acceptable. A company must carefully review the supporting data to evaluate whether it can withstand a challenge. Remember, FDA is the ultimate decisionmaker.
  • As we have written and counseled in the past, qualifiers minimize, but do not eliminate, risk. If the impression is misleading, there is a problem.
• While OPDP did not specifically refer to its guidance document, “Medical Product Communications That Are Consistent With the FDA-Required Labeling,” (the CFL guidance) it clearly did not believe the references presented in the sales aid supported the claims.² It is too soon to say whether the agency will start analyzing CFL issues more carefully, but is does seem like a potential area of concern.³
• Internal company review of promotional materials, careful analysis of supporting data, and consideration of concerns will, to paraphrase Mr. Robertson’s classic song, help take a load off of potential noncompliance and minimize the weight of government enforcement.

[1] The Warning Letter can be accessed at: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/astrazeneca-pharmaceuticals-lp-664789-08042023.

[2] The CFL (meaning, “consistent with the FDA-required labeling”) guidance is available here: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-product-communications-are-consistent-fda-required-labeling-questions-and-answers.

[3] We prepared a Bulletin on the CFL guidance: https://www.agg.com/news-insights/publications/talk-this-way-fda-provides-guidelines-on-medical-product-communications-consistent-with-the-fda-required-labeling-02-02-2017/.