FDA's Bulk Advertising Citations Continue: CSL Behring And Talecris Get Letters For Their Alpha1 Proteinase Inhibitors

Firms were making similar claims that their products can reduce "lung function decline."

FDA has cited two competing companies for making similar misleading efficacy claims about their alpha1 proteinase inhibitor products.

Two "untitled" letters, both dated March 5, went to Zemaira maker CSL Behring LLC, and Prolastin maker Talecris Biotherapeutics Inc., indicating material inaccurately described the effects of the drugs on lung function, as well as other problems.

Both companies were told to stop using the disputed items: a Zemaira sales aid and a Prolastin patient brochure. A CSL Behring spokesman said in an e-mailed statement the company is working with the FDA to address the problem. Talecris spokeswoman Becky Levine said in an e-mailed statement the company pulled the disputed material and revised it, along with others making similar claims. She said updated promotional material then was submitted to FDA.

Common Problem, Common Solution

The letters contained similar language throughout, including the descriptions of violations and reasoning for them. Both also were signed by Robert Sausville, director of the division of case management for the Office of Compliance and Biologics Quality at the FDA Center for Biologics Evaluation and Research.

FDA's latest move also continues its emerging trend to use bulk mailings to address advertising problems. Similar letters targeting several drug-makers went out address problems with ADHD drug ads in 2008 as well as company-sponsored search engine results ads last year (Also see "Internet Searching May Get ‘Riskier’ For Patients After FDA Citations" - Pink Sheet, 6 Apr, 2009.).

But while the ADHD and sponsored search letters cited nearly every prominent company working in the area, the alpha1 proteinase inhibitor letters targeted only two of the three producers. Baxter Healthcare Corp. also makes two approved Alpha1 Proteinase Inhibitors: Aralast and Aralast NP . No FDA letters related to the product have been posted.

Lung Function Dysfunction

The promotional materials for both Zemaira and Prolastin used nearly identical phrasings in some cases. Zemarira's sales aid said that it "significantly reduced lung function decline," while Prolastin's patient brochure states that "the goal of treatment is to slow 'lung function decline.'"

FDA argues that those phrases and others imply a great benefit than has been shown for the products, which are "indicated for chronic augmentation and maintenance therapy in individuals with alpha1-proteinase inhibitor (A1-PI) deficiency and clinical evidence of emphysema." Also, labeling notes that "the hypothesis that maintaining a serum level of antigenic A1-PI will restore protease-antiprotease balance and prevent further lung damage has never been tested in an adequately-powered controlled clinical trial."

Superiority Claims Denied

King of Prussia, Pa.-based CSL Behring cited data in its sales aid indicating a drop in the decline of lung function using Alpha1 augmentation therapy. Sausville said the data not only incorrectly implied Zemaira could protect the lungs or improve lung function, but also was based on a non-randomized registry study, which did not provide "substantial evidence to support the claim."

The company also took an additional step in the sales aid by including a table comparing A1-PI protein levels in Prolastin and Zemaira, suggesting Zemaira has a higher protein concentration and therefore is better and more effective than Prolastin. Sausville said there is no evidence to support the claim.

Talecris also was cited for using a flawed brochure design. While information about Prolastin's benefits was printed in large letters and stretched over multiple pages, the safety information was difficult to read and printed in a small font. Sausville also said in the Prolastin letter the risk information was in a blocked format on a portion of the second to last page of the 12-page item.

-Derrick Gingery ([email protected])