It's a Heartache: FDA's OPDP Issues an Untitled Letter for Unlawful Promotion of a Cholesterol-Lowering Drug Product

Footnotes for this article are available at the end of this page.

“It’s a Heartache, Nothing But a Heartache.” Yes, the opening lyrics to Bonnie Tyler’s 1977 hit, but also what might have been felt in FDA’s Office of Prescription Drug Promotion when it issued an Untitled Letter to a drug company for unlawfully promoting its cholesterol-lowering prescription product.1

Summary of OPDP Concerns

  • The drug company promoted that its product reduced low-density lipoprotein cholesterol (LDL-C), but they were “not the findings of any study” of the promoted drug; the analysis combined the results of two separate and unrelated studies described in the prescribing information.
    • Further, the company misrepresented the conclusions from one of the studies. The first six weeks of this study was a monotherapy, followed by six additional weeks with the combination therapy. The promotion implied that the study supported twelve weeks of efficacy with the product, which FDA found to be misleading as only the second half of the study tested the therapy.
    • OPDP acknowledged there was an asterisk near the claim to try to explain it more clearly, but it “does not mitigate the misleading claims given that they based it on scientifically unsound analysis.”
  • There were many other problems with the promotional efficacy claims’ reliance on the studies that purportedly supported the statement (e.g., studies differed in patient population, type and dose of statin, duration of the study, and multiple limitations of design and analytic strategy of the studies).
  • The indication was not properly described in the promotional text, omitting material information from the full indication. While the full indication was included in the Important Safety Information section, it was much smaller in font size and space.
  • OPDP objected to the presentation of contraindications, warnings and precautions, which lacked a prominence and readability “reasonably comparable” to the promoted benefits.
    • Specifically, the agency wrote:
      Benefit claims for [drug] are presented in conjunction with colorful graphics and large bolded headlines, with significant white space. However, risk information regarding some of the contraindications is relegated to the bottom of the first page and the remaining contraindications and warnings and precautions are presented on a subsequent page. This risk information is also presented in small font and in paragraph format. We note that some of the most common adverse reactions are presented in the body of the promotional communication in table format under the header “Safety and Tolerability” (emphasis original). However, only presenting common adverse reactions associated with [drug] under this header and relegating the serious risks (i.e., contraindications and warnings and precautions) to the bottom of the page and subsequent page in small font and paragraph format creates a misleading impression regarding the risk profile of [drug] … The overall effect of disclosing risk information in this manner undermines the communication of risk information and thereby misleadingly minimizes the risks associated with the use of [drug].

AGG Observations

  • Don’t bury the risk information. It must be presented clearly in a prominent, conspicuous manner.
  • Any supporting data for claims should be straightforward, and not contorted to fit a square peg in a round hole. To quote another lyric from the aforementioned song: “it’s a fool’s game, nothing but a fool’s game” to get too clever or cute with trying to promote something that simply lacks substantiating data.
  • Companies should consider whether they can use studies to support promotional claims if there are multiple limitations; while qualifiers and disclaimers may help minimize risk, they do not eliminate risk.
  • As we often note in the Promotional Review Committees where we sit, a company might not be able to make a particular claim, because it lacks adequate support. It may be better to break marketing’s heart than to deal with the heartache of receiving an Untitled Letter or Warning Letter from OPDP.


1 The Untitled Letter can be accessed at