CBER’s APLB Issues First Enforcement Letter Since 2015 for Misleading Efficacy Claims

March 7, 2018 – The Center for Biologics Evaluation and Research’s (CBER’s) Advertising and Promotional Labeling Branch (APLB) may not exactly be an enforcement powerhouse, issuing just three Untitled Letters since 2013, but it found fault with CSL Behring LLC’s Website, patient brochure, exhibit panel and sales aid for IDELVION® because these promotional materials allegedly make misleading claims about the effectiveness of the Hemophilia B product.

“There has not been much enforcement from CBER in recent years on ad promo issues, and as a consequence some companies may feel they can deviate from the FDA rules and policies,” said Wayne Pines, senior director, APCO Worldwide. “Letters like this reinforce that FDA will take action when it deems necessary to enforce its rules.”

Idelvion (Coagulation Factor IX (Recombinant), Albumin Fusion Protein) is indicated in children and adults with Hemophilia B for: (1) on-demand treatment and control of bleeding episodes; (2) perioperative management of bleeding; and (3) routine prophylaxis to reduce the frequency of bleeding episodes. Its prescribing information states multiple risks of the product in its “Warning and Precautions” section.

However, the promotional materials for Idelvion contain claims and presentations, according to APLB, that “misleadingly overpromise the effect that the drug will have on a hemophiliac patient’s activities and overall quality of life.”

APLB states in the Feb. 27 letter that the Idelvion promotional materials depict a man playing soccer, “which is considered a moderate to dangerous high-risk activity for hemophiliac patients because of the bleeding risk associated with the cuts, scrapes, contusions and similar injuries that occur when people engage in such activity.”

The materials’ depiction of a man ready to kick or head a ball while jumping high in the air is misleading because “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,” APLB asserts. Also, the impact of landing after a high jump “could cause injury to the joints or bones.”

The Untitled Letter also states that CSL Behring’s claims and presentations in these promotional materials “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.”

This Untitled Letter is the first enforcement letter issued by APLB since 2015; the letter prior to that one was issued in 2013. APLB’s last Warning Letter was issued in 2010.