The New York Times reports that the FDA is now working under the assumption that the deadly contamination of heparin was intentional. In her prepared testimony before a congressional subcommittee, Janet Woodcock, director of the FDA’s Center for Drug Evaluation said,
FDA’s working hypothesis is that this was intentional contamination, but this has not been proven.
More details, inside…
The FDA discovered that the drug was contaminated with oversulfated condrotin sulfate, which mimics heparin, thus eluding routine tests. Baxter President Robert L. Parkinson Jr. said in his testimony that his company is “greatly concerned that our heparin product appears to be the target of a deliberate adulteration scheme.” Additionally he said,
“The complexity of the global drug supply chain creates new and emerging risks that call for new ways of thinking about, identifying and addressing vulnerabilities, and that resting on old standards – even ones that have worked for decades – is no longer enough.
It should be interesting in the coming months to see whether this turns out to be another case of Chinese factories trying to save money or actually a case of malicious intent.
Heparin Contamination May Have Been Deliberate, F.D.A. Says [New York Times]
FDA Official: Heparin Contamination May Have Been Intentional [Fox News]