Don’t You Forget About Me: FDA Kicks off 2018 with Letters on Promotional Activities

FDA’s Office of Prescription Drug Promotion (OPDP) issued only five letters in 2017 (compared to eleven in 2016 and nine in 2015). This relatively slow year left some prescription drug manufacturers wondering if, to quote the classic Simple Minds 1980s song, FDA would “call their names, or walk on by” promotional activities that might have previously drawn a Warning Letter or Untitled Letter. In February, the agency reassured industry that it hasn’t forgotten about promotional activities, issuing one letter from OPDP, and one from the Center for Biologics Evaluation and Research (CBER).

OPDP Warning Letter


    • The OPDP Warning Letter addressed a company’s exhibit booth at a 2017 pharmacy conference. The product at issue was an extended-release opioid with an abuse-deterrent formulation. The product has a Boxed Warning and limitations of use, but none of this information was provided on the exhibit booth’s principal display panel.


    • FDA pointed out that omitting information can make the otherwise truthful presentation of information misleading. Here, the exhibit failed to display material facts about potential consequences of using the product.


    • The agency also noted that a side panel of the exhibit did include information on the limitations of use, contraindication, and Boxed Warning, but this side panel was located several feet away from the principal display panel. The principal display panel used a blue background and large font, but the side panel used a much smaller font size and plain white background, lacking “any visual elements linking it to the principal display panel.”


    • The principal display panel presented benefits claims regarding the product’s abuse-deterrent formulation at eye level, in an easy-to-read format. However, the limitation of this formulation to prevent abuse was presented at the bottom of the panel, near the floor, with less prominence than the benefit claims. An OPDP representative at the convention also observed that the limitation information was obscured by a table and chair, making the material “not visible to viewers as a practical matter.”


  • Additionally, OPDP had provided advisory comments on draft presentations for the product, which were similar to the exhibit booth at issue. OPDP had both recommended that the company revise the presentations so as not to misrepresent the indication, and cautioned the company to present risk information with prominence and readability comparable to the presentation of benefits.


CBER Untitled Letter


    • CBER issued its first letter concerning promotional activities since 2015 for various promotional materials that made misleading claims about the effectiveness of product approved to treat hemophilia. The product’s promotional materials (a website, patient brochure, exhibit panel, and sales aid) featured an image of a man about to engage in heading or kicking a soccer ball while jumping in the air—an activity CBER considered to be a moderate to dangerous high-risk activity for hemophilic patients.


  • The letter described the immediate and secondary risks of injury and trauma for a hemophilic patient engaging in this activity, noting that even a patient whose hemophilia is well controlled and being treated through a routine prophylaxis regimen, such as the product at issue, will still have a serious risk for bleeding while engaging in this activity. The materials imply that patients using the product can engage in this activity without consequences.


AGG Observations 


    • The way information is presented matters, and merely including safety information may not constitute fair balance, if that safety information is buried in a promotional display. Every promotional piece is different, but consider the prominence, visual appeal, and frequency of promotional claims when evaluating pieces for fair balance. If the safety information is in small font and presented only at the very end of the presentation, a viewer may not be able to easily read and understand it.


    • A company’s internal promotional review committee should evaluate all pieces as a whole, with context on how these pieces will be utilized. When reviewing an exhibit booth, for example, it is useful for team members to see a mockup of where each panel in a display will be positioned, to ensure that safety information is presented to viewers in a balanced and prominent manner.


    • Do not truncate a product’s indication. When a product’s prescribing information contains limitations of use, those limitations should be provided in close proximity to the indication. Omitting or downplaying this information is misleading.


    • When FDA provides product-specific comments, companies should be mindful of these comments when developing future iterations of promotional materials, not only launch materials. If the agency has spoken to a particular concept or claim, a company has guidance on the risk associated with that concept or claim, and should proceed accordingly.


    • Visuals are important. A company can make implied quality of life claims without words. Companies should review materials featuring patients to ensure that the activities, ages, and patient types featured appropriately match the population for which the product is indicated.


  • We have previously written about the developments and uncertainty around FDA’s approach to off-label promotion. However, FDA is not abdicating its authority to take action against what the agency considers to be unlawful promotion, particularly when omission or minimization of risk information creates a potential safety issue.