Remember that contaminated-heparin snafu back in 2008? Well, a couple of congressmen have been investigating the FDA's handling of that crisis--and the agency has come up wanting. According to the Wall Street Journal, which reviewed the probe's findings, the FDA didn't follow up on several "specific and credible leads" as they tried to trace the heparin contamination to its source.
U.S. Reps. Joe Barton (R-Texas) ranking member on the House Energy and Commerce Committee, and Michael Burgess (R-Texas), ranking member of the Oversight and Investigations Subcommittee, say they have new information related to the heparin contamination investigation and have asked FDA Commissioner Margaret Hamburg to answer questions on the agency's handling of the investigation.
Hundreds of adverse events were reported in late 2007 and early 2008 related to the blood-thinner. As the news broke, the agency was scrambling to discover where the contaminant, chondroitin sulfate, came from, and who was responsible. Although the FDA eventually determined that the substance had been added to the drug in China, it said it couldn't check out all the possible sources. We still don't know the who, where or when.
"We are very troubled by how FDA has handled the investigation to find out who was responsible for the contamination of heparin," the members say in the letter. "The [minority] staff has learned that FDA has specific and credible information about certain Chinese heparin firms that warrants further investigation as suspect entities responsible for contaminating the heparing supply. However, the availabe information does not indicate that FDA has adequately followed up on these specific and credible leads."
The FDA declined to comment to the Journal that it's preparing a response to Barton and Burgess.