Rep. Dingell asks government to review FDA’s handling of heparin cases

11/24/2008

WASHINGTON Rep. John Dingell, D-Mich., has requested that the Government Accountability Office review the Food and Drug Administration’s management of safety of supplies of the blood-thinning drug heparin in the United States, according to a letter he submitted to acting GAO comptroller general Gene Dodaro dated Nov. 19.

Dingell, who is chairman of the House Committee on Energy and Commerce, noted that the FDA had “conclusively linked” deaths of three patients given heparin to a foreign substance found in lots of the drug manufactured by Baxter Healthcare Corp.

“While I do have questions about the adequacy of FDA’s investigation and evaluation of recent heparin deaths, I emphasize that I still support FDA’s actions in imposing import alerts and requiring additional testing in dealing with the heparin safety problem,” Dingell included in the letter. “My hope is that the GAO?s review will determine the strengths and weaknesses in FDA’s response to the heparin drug safety problem, and will make recommendations on what FDA could do better in dealing real-time with an emerging drug safety problem in the future.”

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