Drug trafficking in the US is a major problem. How about the importation of tainted medications? Aren’t they equally concerning? Shouldn’t there be someone attempting to put a stop to each of these major problems?
According to recent reports, lawmakers are actually attempting to do something about the latter of the two. Apparently, two Chinese companies implicated in supplying contaminated ingredients three years ago to Baxter International Inc. (BAX) for its blood thinner Heparin are still supplying product to the U.S., Republican lawmakers said.
The tainted Baxter heparin caused serious, and in some cases fatal, allergic reactions in scores of patients. Therefore, Baxter International Inc. recalled nearly all its heparin injections in the U.S. in January 2008. The FDA eventually initiated 13 recalls of multiple contaminated medical products containing heparin from several companies. Eighty-one US deaths were ultimately tied to the contaminated heparin.
Then, in March 2008, the FDA confirmed that it had found oversulfated chondroitin sulfate that was molecularly changed to mimic heparin’s blood-clotting properties in samples of the active ingredient used in Baxter heparin. Chondroitin sulfate costs a fraction of the ingredient usually used in heparin, and producers may have used it in an attempt to cut costs.
The counterfeit ingredient was supplied to Baxter by Changzhou SPL, a Chinese plant partially owned by Wisconsin-based SPL. Changzhou used two companies to supply it with a raw ingredient made from pig intestines, as is chondroitin sulfate. Those consolidators obtained the ingredient from unregulated workshops.
And, now October 26, 2011 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, voicing their concerns and asking why the agency hasn’t warned drug manufacturers to avoid product from the Chinese companies. This 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.
A statement issued by the Committee also voices concern that tainted heparin could still pose a risk to the 12 million U.S. patients treated with the drug every year.
The Committee stated that they are trying to understand The FDA’s enforcement policy and what exactly they are planning to do or have done about this situation. They requested that Dr. Hamburg respond to the letter by November 9, 2011.