Two Chinese companies implicated in supplying contaminated ingredients three years ago to Baxter International Inc. for its blood thinner heparin are still supplying product to the U.S., Republican lawmakers said.
Baxter recalled the blood thinner in 2008 amid reports of deaths and allergic reactions. The Republicans, led by Representative Fred Upton of Michigan, chairman of the House Energy and Commerce Committee, wrote Food and Drug Administration Commissioner Margaret Hamburg, asking why the agency hasn’t warned drug manufacturers to avoid product from the Chinese companies. Today’s letter didn’t name the companies.
“We have reason to believe that these two Chinese firms are still supplying crude heparin that is being imported into the United States,” the lawmakers wrote Hamburg. “We have seen no indication that the FDA has issued warning letters and/or import alerts to these firms even though FDA has issued warning letters and import alerts to other Chinese heparin firms.”
Heparin is given to about 12 million people in the U.S. each year, according to the lawmakers’ letter. Committee Republicans again began investigating contaminated heparin in February. The committee expanded its investigation in May to seek information from U.S. Immigration and Customs Enforcement and from industry leaders in June.
“We have very serious public health concerns arising from our investigation,” Upton and four colleagues wrote.
Deborah Spak, a spokeswoman for Baxter, didn’t immediately respond to a request for comment on the letter. Spokeswomen for the FDA also couldn’t be immediately reached.