Congress queries ICE over 2008 heparin contamination

Rekindling its investigation into the 2008 incident of heparin contamination that killed dozens of Americans and sickened many more, the House Committee on Energy and Commerce has fired off a letter to U.S. Immigration and Customs Enforcement requesting all of the documentation it has on the matter. Republicans on the committee remain dissatisfied with the results of investigations by the FDA.

"Neither the Chinese government nor the FDA has identified those responsible for the contamination or described how the heparin actually came to be contaminated," says the letter to ICE director John Morton. Those responsible may still be "actively engaged in the Chinese pharmaceutical supply chain." The letter is signed by chairman Fred Upton and four other committee members. They request by mid-June all documents relating to the adulteration of the U.S. heparin supply, beginning January 1, 2008.  

The request to ICE follows by about a year a warning letter of sorts the committee sent to FDA Commissioner Margaret Hamburg. The FDA in 2008 was able to link contaminated heparin marketed by Baxter to the active ingredient supplied by Chinese exporter, Chongqing Imperial.

In the 10-page missive, Reps. Joe Barton and Michael Burgess, both also signers of the letter to ICE, note Chongqing's involvement, but they say "available information does not indicate that FDA has adequately followed up on these leads. We are very troubled by how FDA has handled the investigation."

- see the story
- here's the letter

Suggested Articles

In a first, the FDA and Indian oversight agencies worked together to block illegal drugs from entering the U.S. 

After months of delay for ultra-pricey gene therapy Zynteglo, Bluebird Bio is hoping to dose its first German patients in the first half of the year.

North Carolina is providing some financial assistance for the construction of Audentes gene therapy facility in Sanford, North Carolina. (Astellas)