FDA’s Not Dead Yet: The Agency’s OPDP Issues First Untitled Letter for 2023

Before Comedy Central, TikTok videos, and other social media inventions, Monty Python entertained us (admittedly, an acquired taste). Many of us remember the classic scene from the 1975 movie Monty Python and the Holy Grail, where John Cleese brings a sickly man to the plague cart, which is touring the village for dead people, and the elderly man says, “I’m not dead yet.” This line came to mind when we saw that the Food and Drug Administration’s Office of Prescription Drug Promotion (“OPDP”) recently issued its first Untitled Letter/Notice of Violation for unlawful drug promotion in 2023. This letter reminds industry that OPDP is not dead yet; it will continue to issue letters and require corrective action when it believes a drug promotion is unlawful.

In this Bulletin, we will summarize OPDP’s concerns and offer our own observations.

• OPDP objected to false and misleading claims about the prescription drug’s efficacy on product webpages found on a consumer website.
  • Statistics to support a promotional claim overstated the product’s efficacy (while the statistic was in the FDA-approved prescribing information (“PI”), the agency questioned the claim’s verbiage).
  • The presentation did not include material information necessary to properly interpret the study results. The PI stated, “These results should be interpreted with caution.”
  • Failure to provide the material information on the webpage did not allow the reader to fully “understand and evaluate the study results presented and thereby creates a misleading impression about the drug’s efficacy.”
• Another webpage claim implied that the study results represented the general experience of patients. However, the results were “based on a small, select subset of patients enrolled in the study who had already demonstrated that they were able to tolerate and respond to the drug.”
• OPDP expressed concern about the presentation of risk information.
  • The company noted “[s]ide effects can occur with the [product], including some that are serious,” without providing information about its boxed warnings or specific (and some potentially fatal) side effects associated with the drug.
  • References to “avoiding” side effects were misleading. FDA said the webpage’s presentation was concerning, because a number of patients who took the product in clinical studies experienced these potentially life-threatening side effects.
• FDA recognized that the company presented risk information separately in the “INDICATION AND IMPORTANT SAFETY INFORMATION” section of the webpage. However,

it did not mitigate the misleading impression created by the “Monitoring and side effects” presentation because the boxed warnings are relegated to the middle of this consolidated risk section, after the contraindications and indication and use statement, and without any significant signal to alert the reviewer to therm. The overall effect of this webpage’s presentation of risk information undermines the communication of the significant and potentially fatal risks associated with [product] and thereby misleadingly minimizes the risks associated with the use of [product].

AGG Observations

• Boxed warning product. Consumer webpage. Minimization of risk. Overstatement of efficacy. If we were playing the $25,000 Pyramid game (or the successor), we might answer, “Product promotion deficiencies likely to risk an Untitled Letter or Warning Letter.” Candidly, we’re a little surprised OPDP issued “only” an Untitled Letter and not a Warning Letter based on how OPDP has responded in the past with similar concerns regarding unlawful promotion for Boxed Warning products (incidentally, the same company received an Untitled Letter for a different product a few years earlier).¹
• Always tell a complete story. In this case, OPDP took exception to the description of the clinical data, noting that it was misleading as presented.
• A company should put risk information in the text or body of the ad if the indication or claims are there. It is not sufficient to include it in the Important Safety Information if the positive messaging is more prominently included.
• Relying on a PI is a good idea to support a promotional claim, but omitting or overstating certain information can get a company into trouble. Similarly, not including proper context for the data, which may help tell a more accurate story, can make a claim misleading.
• OPDP is not dead. And we don’t think it’s going away anytime soon.

[1] We are not suggesting that the company deserved a Warning Letter in this case.