House Investigates Heparin Crisis

Publication: The Wall Street Journal

Author: Alicia Mundy


02/23/2011 - The House Energy and Commerce Committee is conducting a formal investigation into the contaminated-heparin crisis of 2008, saying it wants regulators to figure out who was responsible for adulteration linked to 81 U.S. deaths.

The panel's chairman, Rep. Fred Upton (R., Mich.), and two colleagues sent a letter Wednesday to the Food and Drug Administration asking for documents on whether the agency pursued possible culprits in China and pushed the Chinese government for more information.

"The committee is investigating the unsolved case of who contaminated the U.S. supply of heparin," a blood thinner used by about 12 million Americans annually, said Mr. Upton, joined by Reps. Clifford Stearns (R., Fla.) and Michael Burgess (R., Texas).

"There is substantial public interest in solving this case" because more than 80% of the standard heparin supply in the U.S. today comes from China, the lawmakers wrote. About 16% of all pharmaceutical ingredients in the country are imported from China, they wrote.

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"The number of drug products made at non-U.S. sites has doubled in the past decade. The FDA's ability to ensure the quality at these sites has not," said Allan Coukell of the Pew Charitable Trusts, who has been researching the safety of the U.S. drug-supply chain.

Read the full article House Investigates Heparin Crisis on the Wall Street Journal's Web site.

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