Lawmaker asks for heparin review

Internal Medicine News, Jan 1, 2009 by Jane Anderson

U.S. Rep. Joe Barton (R-Tex.), ranking minority member of the House Energy and Commerce Committee, has asked the Government Accountability Office for a thorough review of the Food and Drug Administration's handling of the recent problems with tainted heparin coming from China. In February 2008, Baxter Healthcare Corp.

recalled several heparin products and the FDA identified a previously unknown contaminant in the heparin. According to the FDA, 246 people died after heparin administration between Jan. 1, 2007, and May 31, 2008, and 149 of those deaths involved allergic symptoms or the appearance of hypotension, the group of symptoms that prompted the drug recalls. Rep. Barton's letter to the FDA challenges the agency's attribution of several deaths to heparin and questions whether the FDA used "all of the tools available" to investigate the deaths. "My hope is that the GAO's review will de-termine the strengths and weaknesses in the FDA's response to the heparin drug safety problem, and will make recommendations on what the FDA could do better in dealing real-time with an emerging drug safety problem in the future," Rep. Barton wrote.