FDA WARNING_LETTER - Baxter International Inc.

The FDA's Center for Biologics Evaluation and Research (CBER) issued a Warning Letter to Baxter Healthcare Corporation regarding their Aralast NP Physician Brochure (HYL 4084A/HYL4084B). The brochure misbrands Aralast NP [Alpha 1-Proteinase Inhibitor (Human)] by making misleading efficacy claims, violating the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 352(a) & (n); 321(n)) and FDA regulations (21 CFR 202.1(e)(6)(i), and (x)).

The FDA noted a pattern of similar violations, citing Baxter for overstating efficacy and making unsubstantiated superiority claims in previous Warning Letters (April 14, 2009) and Untitled Letters (July 7, 2008). The approved product labeling for Aralast NP explicitly states that long-term effects, impact on pulmonary exacerbation, and progression of emphysema have not been demonstrated in randomized, controlled clinical trials. It also states that the clinical benefit of increased blood levels of Alpha 1-Proteinase Inhibitor at the recommended dose has not been established, and the "protective threshold" has not been proven.

The brochure's misleading statements include claims like "ARALAST NP exceeds ATSIERS standards for [alpha1-proteinase inhibitor]