WASHINGTON – Scientific tests have turned up possible irregularities in some samples of a blood thinner linked to several deaths and hundreds of life-threatening reactions, a spokeswoman for the manufacturer said Thursday, as questions mounted about FDA oversight of drug production overseas.
Baxter Healthcare Corp.’s advanced testing found “trace differences” in some lots of the blood thinner heparin, including quantities in which the active ingredient was produced at a supplier’s plant in China, spokeswoman Erin Gardiner said.
Baxter and the Food and Drug Administration said it was too early to say whether the problems were caused by the ingredient made in China. But the disclosure is likely to add to consumer worries about goods from China after product safety scares in the past year involving Chinese-made pet food ingredients and toys. The disclosure also raised questions about FDA oversight, since the agency has never inspected the plant in China.
Several lawmakers in Congress said the case underscored a gaping hole in the FDA’s inspection program: Although most of the bulk drug ingredients used by U.S. manufacturers are imported, the FDA inspects only about 7 percent of foreign establishments in a given year. According to a recent congressional report, the chronically underfunded agency does not even have an accurate count of foreign drug plants under its jurisdiction. Many have never been inspected.
“How do you allow these drugs into this country when you don’t even inspect?” asked Rep. Bart Stupak, D-Mich., a leading FDA critic. “Where is the enforcement to make sure you are doing things right?”
Baxter emphasized that its investigation was continuing and that no conclusions had been reached.
“Baxter has detected differences between lots (of the active ingredient) but it’s unclear what the impact of these differences is,” Gardiner said. “They are not necessarily the root cause of the increase in adverse reactions, but they are certainly a central part of our investigation.”
Some of the samples that were found to have differences “are definitely from China,” she added. Earlier testing before the drug was shipped to hospitals and dialysis centers fully complied with industry and regulatory requirements, Gardiner said, but the previous tests were not as sophisticated and failed to detect any possible problems.
Baxter identified the supplier of the heparin as Scientific Protein Laboratories of Waunakee, Wis. The company’s Web site says it maintains manufacturing facilities in Waunakee and Changzhou, China, about two hours’ drive west of Shanghai. It said that both plants adhere to the same industry and FDA safeguards, adding that SPL provides bulk heparin to Baxter, which further processes and packages the product at a facility in Cherry Hill, N.J.
Baxter said Monday that it had suspended manufacturing of multiple-dose vials of heparin after receiving reports of four deaths and 350 bad reactions. The drug helps prevent the formation of dangerous blood clots during surgical procedures, and the FDA said doctors continuing to use the Baxter product should carefully monitor patients for signs of allergic reactions.
Heparin is a naturally occurring substance extracted from pig intestines and cow lungs. Some independent experts said contamination could have occurred at any point in the production process, from a problem with raw materials to the wrong kind of solvent being used to clean equipment.