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Rep. Barton Presses FDA For Information About Tainted Heparin

By Jared A. Favole, Of DOW JONES NEWSWIRES

WASHINGTON -(Dow Jones)- Rep. Joe Barton, R.-Texas, is pressuring the U.S. Food and Drug Administration for more information about contaminated heparin from China amid concerns that the agency doesn't know what caused U.S. patients to get sick or die while taking the blood thinner last year.

Barton, the ranking member on the House Energy and Commerce Committee, wants the FDA to turn over any databases that show heparin was contaminated, according to a letter sent to Acting FDA Commissioner Joshua Sharfstein.

In early 2008, the FDA began investigating heparin, essential for procedures such as cardiac surgery, after receiving hundreds of reports of allergic reactions and dozens of deaths in patients who had taken the blood thinner.

The FDA has said the raw heparin came from factories in China and was purposefully contaminated, for economic reasons, with a man-made chemical called over-sulfated chondroitin sulfate, or OSCS. Chinese drug officials have disagreed with the FDA, saying OSCS may not be responsible.

The FDA's handling of the issue has drawn scrutiny, especially from Barton. He has asked the investigative arm of Congress, the Government Accountability Office, to investigate the FDA's response to the heparin affair. The GAO said it recently began its investigation but couldn't provide a time frame for when it would be finished.

Barton wants to know if the FDA tracked the origins of the contamination and whether the agency has sought assistance from the Chinese government. He also wants to know what actions, if any, the Chinese government has taken related to the contamination.

A Republican staffer for the Energy and Commerce Committee said Barton is trying to determine whether anyone in China has been held responsible for contaminating heparin that ultimately sickened and killed U.S. citizens.

"We don't seem to be any further along a year later from understanding" this issue, said the staffer, who asked not to be named. "What are they doing about it? Is this an acceptable practice in China?"

The heparin issue doesn't seem to be going away. Last month, the FDA publicized documents showing two Chinese-based companies shipped contaminated heparin to the U.S. between 2007 and 2008 and one lied to federal health regulators about their role in the matter. It was the first public disclosure of the firms involvement in the heparin matter.

On Friday, the agency held a public hearing to better understand how to prevent people from contaminating products for economic reasons.

Imported food and drugs from China have received intense public and congressional scrutiny over the last year, as tainted medicine and toys with lead have reached U.S. shores and sickened people. The FDA has responded to congressional and public concerns by opening offices in China to help it better oversee products imported to the U.S.

Barton wants the FDA to respond to his letter within two weeks.

-By Jared A. Favole, Dow Jones Newswires; 202-862-9207; jared.favole@ dowjones.com

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