U.S. health regulators have failed to identify those responsible for the widespread contamination of the blood thinner heparin, three years after the drug made by Baxter International Inc. was recalled, a House of Representatives panel said on Wednesday.
In a letter to the Food and Drug Administration, the House Energy and Commerce Committee, led by Republican Fred Upton, called on the agency to release all documents related to its investigation into the drug and ingredients from China.
The tainted drug, recalled in 2008, led to deaths of at least 149 people. FDA investigators tracked the problem to tainted raw ingredients sourced from China, where small, mostly unregulated farms supply the pig intestines used to help make the drug.
"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)," Upton and his colleagues wrote.
"We believe there is substantial interest in solving this case," they said in the letter, posted on the committee's web site.
FDA representatives did not immediately respond to a request for comment.
Heparin is widely used to reduce blood clotting with open heart surgery. It also treats many other heart and circulatory conditions and is used in kidney dialysis.
The agency has found evidence that batches of heparin sold by Baxter had been tainted with a chemical made to mimic the drug but cost less. Baxter's CEO told Congress at a 2008 hearing that the contamination must have been deliberate.
The FDA has since moved to expand its operations and inspections in China following the heparin recall in addition to other scandals involving the chemical melamine in pet food and other products from the Asian nation.
Baxter had been the leading U.S. supplier of the blood thinner, which is also made by other companies, such as APP Pharmaceuticals.