House Committee Targets FDA In Heparin Probe
3 CommentsBy Ed Silverman // February 23rd, 2011 // 4:41 pm
Three years after the FDA linked the Heparin scandal to contaminated supplies from China, a Congressional committee has lashed out at the agency for failing to find the culprits behind the episode and has now written FDA commish Margaret Hamburg to release all documents related to the agency investigation.
You may recall that contaminated heparin made in China was linked to 81 deaths in 2007 and 2008 (back story), and the episode sparked a firestorm of criticism at the FDA for its failure to monitor medicines made there (background).
“There is reason to believe all or some of the individuals responsible for the adulteration are still actively engaged in the Chinese pharmaceutical supply chain and pose a continuing threat to pharmaceutical products imported to the (United States),” Fred Upton, a Michigan Republican who chairs the House Energy and Commerce Committee, and two colleagues wrote in their letter. “We believe there is substantial public interest in solving this case.”
They noted that about 80 percent of the US heparin supply comes from China, and about 16 percent of all pharmaceutical ingredients are also imported from China. An FDA task force had identified the substance that contaminated the heparin, which made the treatment more valuable, and that the move was economically motivated. But the FDA has not disclosed any additional info.
Last summer, the FDA was chastised by Republicans on the same committee, where they were a minority at the time, for not moving faster to complete its probe (look here). In their defense, FDA officials told Congress they repeatedly asked the Chinese government for help in pursuing an investigation, but were “severely hampered” by a lack of cooperation.
RReviewer
Goodbye Dr. Woodcock…
David Lagunoff
What I don’t understand is why heparin quality is not monitored in the US. Relatively straight forward established chemical tests are available to assess the extent of heparin sulfation. Why weren’t these tests used routinely by the US company and or the FDA in addition to measuring anticoagulation, particularly since heparin is an animal product prepared from pig intestine not a synthesized molecule. Protein content of the preparations which could have contributed to the toxicity should also have been measured.
John English
As I recall the history of the event, David, the issue was that the “heparin api” shipped in had been modified in a way that beat the identity tests that were commonly is use. The tests have subsequently been changed to address this issue.