Note: The following is a summary of a letter dated Feb. 27, 2018, from the US Food and Drug Administration (FDA) to CSL Behring. You can read the original letter here.
The FDA has advised CSL Behring that the company’s promotional materials make misleading claims about the effectiveness of its Idelvion (Factor IX) product. “Such claims cause a drug to be misbranded within the meaning of the Federal Food, Drug, and Cosmetic Act . . . and make its distribution violative under” the statute and implementing regulations.
FDA points to illustrations used by CSL that show a man playing soccer. FDA states that CSL’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 requests that CSL immediately cease the dissemination of these promotional materials for Idelvion.