Congress issues 'warning letter' to FDA over 2008 heparin deaths

Labeling as inadequate the FDA's follow-up to "specific and credible information" linking Chinese drugmakers to the lethal 2007-2008 distribution of contaminated heparin, Congress has issued its own sort of warning letter to the regulator, outlining deficiencies and requiring a timely reply.

U.S. Representatives Joe Barton and Michael Burgess, both Texas Republicans, have posed pointed questions to FDA Commissioner Margaret Hamburg via a 10-page letter, following the discovery of information concerning exporter Chongqing Imperial's involvement in the contamination incident. Among them: What is the FDA's strategy for resolving who contaminated the heparin supply? Assuming the agency finds out, what will it do with the information? Does the FDA agree that the contamination of the heparin supply is an international issue? If so, why hasn't it sought international support from the World Health Organization and others?

The FDA's own documents show that Chongqing-produced heparin was involved in various supply chains that had contaminated lots, says a Congressional announcement. "Available information does not indicate that FDA has adequately followed up on these leads," the legislators write. "We are very troubled by how FDA has handled the investigation."

The lawmakers have asked Hamburg, whose appointment as commissioner followed the incident, for answers by end of May.

- see the release from Congress
- here's the letter

Suggested Articles

Popular logic says you never switch horses, or CDMOs, in the middle of the stream, but Acacia Pharma had to do that to win an FDA approval.

The FDA has found issues with the testing practices of a U.S. generics maker that had specific problems with ADHD and weight-loss drugs.

A warning letter says Chinese API maker Yibin Lihao Bio-technical was found lying to the FDA about manufacturing unapproved heparin.