One is a sales aid, and one is a consumer brochure, but both ads -- for CSL Behring's Zemaira and for Talecris' Prolastin -- are false or misleading, FDA said in a pair of untitled letters.
The brochure for Prolastin minimized risks by featuring "multiple pages of easy to read benefit information...presented with large lettering and white spacing," in contrast to small font and blocked-format safety information "on the second to last page of a 12-page brochure," FDA's Office of Compliance and Biologics Quality (OCBQ) said in the letter.
Additionally, the brochure made several claims related to improved lung function, which imply "a greater benefit for Prolastin-treated patients than is suggested by the PI, or by substantial evidence or substantial clinical experience," according to the letter.
The Zemaira sales aid made similar unsubstantiated claims related to lung condition, and also used a comparative table — Prolastin vs. Zemaira — that wrongly positioned Zemaira as the "superior or more effective" treatment. The OCBQ letter pointed to a headline on the sales aid — "Unmatched purity. And peace of mind" — as a reinforcement of the misleading comparative claim.
Both drugs, made from human plasma, are indicated for chronic augmentation and maintenance therapy in people with alpha1-proteinase inhibitor (A1-PI) deficiency, a hereditary disorder that can cause severe tissue damage and death. Emphysema and other pulmonary diseases are one of the main results of A1-PI, and patients treated with Zemaira or Prolastin are required to exhibit clinical evidence of emphysema.
Greg Healy, a spokesman for CSL Behring, told Bloomberg that the company is "working with the FDA to address its concerns," and is no longer using the sales aid. Both CSL Behring and Talecris were asked to "immediately cease the dissemination" of their respective materials, and to respond within 10 business days regarding plans to comply with the request.