he Chinese plant at the center of a controversy over the safety of half the nation's supply of the blood thinning drug heparin had problems involving impurities, the quality and use of its equipment, and overall quality control, a preliminary inspection by the Food and Drug Administration found.
In a heavily redacted report made public yesterday, the FDA inspectors also described at least one instance of the company using active ingredients -- which are made from pig intestines -- supplied by a "workshop" deemed to be "unacceptable." Heparin made from that source, the report said, was marketed to the United States.
Also yesterday, the maker of the drug, Baxter International, recalled virtually all of its remaining heparin products. Earlier this month, the firm stopped production, but the FDA wanted to keep the existing Baxter heparin in doctors' hands because it did not want to cause a shortage of the life-saving drug. Agency officials said increased production by the other heparin manufacturer can now satisfy the demand.
Sandra Kweder, deputy director of the FDA's Office of New Drugs, Center for Drug Evaluation and Research, said in a teleconference that the agency had not found the "root cause" of the problems linked to Baxter's heparin. Since December, the drug, used as a blood thinner during surgery and dialysis, has been associated with almost 450 "adverse event reports" of allergic reactions and at least four deaths.
The problems with Baxter's heparin, and FDA's oversight of its production in China, have become emblematic of the changing nature of the nation's drug supply -- with growing amounts made abroad, especially in India and China. While imports from nations without strong regulatory agencies of their own have skyrocketed, FDA's budget for inspections has not.
The plant that made heparin for Baxter -- Changzhou SPL, located near Shanghai -- was supposed to be inspected before it began supplying the American market. FDA officials have acknowledged, however, that they had approved a different plant with a similar name and never reviewed Changzhou's application.
Michael Rogers, FDA's director of field investigations, said yesterday that the inspection of the heparin refining plant was complete, but a full analysis of what the inspectors found is continuing.
He also said the inspectors are still in China looking at "consolidators" that buy and begin processing the pig intestines, which often come from pigs raised and slaughtered in village farms, then sell their product to companies such as Changzhou SPL. The plant is majority-owned by an American company, Scientific Protein Laboratories of Waunakee, Wis.
SPL President David Strunce said in a statement that the FDA has not determined the Chinese plant was the source of the heparin problem. He also said, "The facility was specifically designed to comply with all of the standards set forth in FDA's current Good Manufacturing Practices (cGMP) regulations."
The issue of inspecting foreign suppliers has become increasingly important on Capitol Hill, with several efforts underway to assure that the FDA gets more money to conduct inspections. Sen. Robert Menendez (D-N.J.) yesterday sent a letter to President Bush arguing that the agency's budget must grow.
"As we've seen recently, the FDA can't even keep track of which company they should be inspecting," he wrote. "This lack of oversight by both the country of origin and the U.S. FDA puts American consumers at risk."
Rep. Bart Stupak (D-Mich.), who chaired hearings on the issue for the House Committee on Energy and Commerce, said, "The sad reality is that Americans can expect more episodes similar to what we are now seeing with heparin unless FDA implements wholesale changes."
source: washingtonpost.com
2/29/08
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