Public release date: 29-Apr-2008
Contaminated heparin, a blood thinner used in dialysis and other treatments, has been connected to 81 deaths and 785 severe allergic reactions, said Rep. Bart Stupak, D-Mich., chairman of the House Energy and Commerce subcommittee on oversight and investigations.
The heparin, made from ingredients imported from China, has been recalled by Baxter International and the Food and Drug Administration has blocked imports from the Chinese company.
The FDA found the drug was contaminated with oversulfated condroitin sulfate, which mimics heparin and thus was not detected in routine testing, Stupak noted.
When it was introduced into the product has not yet been determined.
Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, told the subcommittee that in recent years major changes have occurred in where drugs are made.
For example, in 2007 the agency received only about 150 applications for approval to make generic drugs in the United States compared to nearly 500 from China and more than 400 from India, she said.
“Great vigilance is required to maintain” drug safety, she said.
Baxter president Robert L. Parkinson Jr., said in testimony prepared for the subcommittee that his company is “greatly concerned that our heparin product appears to be the target of a deliberate adulteration scheme.”
“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,” Parkinson said