FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

CBER Faults Drugmaker for Implying Hemophilia Drug Allows Patients to Engage in High-Risk Activity

March 8, 2018

CBER’s advertising and promotional labeling branch sent an untitled letter to a drugmaker in Pennsylvania saying the company overpromised the impact of its hemophilia treatment.

In the Feb. 27 letter to CSL Behring in King of Prussia, CBER said the company’s promotional materials for its Idelvion — including websites, patient brochures, sales aids and exhibit panels — were misleading.

The promotional materials featured an image of a man playing soccer, a high-risk activity for hemophilia patients that can result in intracranial bleeding, contusions, concussions or injury of the face. The risk remains even for patients being treated with a routine prophylaxis regimen like that of Idelvion, recombinant human blood coagulation factor, or whose hemophilia is otherwise well-controlled, CBER said.

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