The advertising and promotional labeling branch (APLB) at the US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research on Tuesday released an untitled letter sent last week to Pennsylvania-based CSL Behring for claims and presentations that “misleadingly overpromise the effect that the drug will have on a hemophilic patient’s activities and overall quality-of-life.”
The letter, the first for the APLB since 2015, takes issue with the company’s website, patient brochure, exhibit panel and sales aid for the treatment Idelvion, which is a recombinant DNA-derived coagulation Factor IX concentrate indicated in children and adults with hemophilia B.
“Specifically, your promotional materials contain an image of a man playing soccer, which is considered a moderate to dangerous high-risk activity for hemophilic patients because of the bleeding risk associated with the cuts, scrapes, contusions, and similar injuries that occur when people engage in such activity,” FDA said.
“The soccer player depicted in your materials appears ready to engage in heading or kicking the ball while he is jumping high in the air. The initial impact of heading a ball could result in various injuries, including, but not limited to, intracranial bleeding from injury or trauma, a contusion, injury of the face, or concussion.”
FDA added that a patient being treated through a routine prophylaxis regimen with Idelvion, and whose hemophilia is well-controlled, “will nevertheless still have a serious risk for bleeding while engaging in such activities.”
Therefore, FDA said the company’s claims and presentations “misleadingly imply that hemophiliacs taking your product can engage in moderate to dangerous high-risk activity without consequences and that such activities are appropriate for typical patients with hemophilia using this product.”
FDA called on CSL to immediately cease the dissemination of these promotional materials and respond within 10 days.
CSL told Focus
via email: "Our campaign for Idelvion was aimed at empowering patients with hemophilia B to take control of their condition, and to encourage them to lead active and healthy lives. However, we acknowledge the FDA’s authority in this matter and have already begun to update our imagery to reflect activities that are lower impact."
Editor's note: Updated with CSL comment.