Since Baxter International announced recently that it was suspending sales of its multidose vials of heparin after four patients died and 350 suffered complications including allergic reactions, many of them serious and potentially life-threatening, significant concerns have arisen as to the effectiveness of the U.S. Food and Drug Administration’s oversight of imported drugs. Baxter bought the active ingredient for heparin, which is derived from an enzyme in pig intestines, from Scientific Protein Laboratories, which produces heparin’s active ingredient in its factory in Changzhou, China.
Scientific Protein moved production to China three years ago because the country is the world’s largest supplier of pigs. Baxter processes, sterilizes and packages the finished product for distribution in the USA. The Scientific Protein Laboratories in Changzhou was never checked by drug regulators in China because the plant has no certification from the government to manufacture pharmaceuticals.
The Food and Drug Administration (“FDA”) violated its own policies when it approved heparin for sale without first inspecting the Changzhou plant. As far as Baxter and Scientific Protien are concerned, this would appear to be a products liability case relating to defective manufacturer, rather than a defective design or failure to warn. According to the FDA, as of mid-February 2008 it had received 350 of side effects linked to Baxter heparin. Four people died while taking the drug, though the agency said it wasn’t clear if the drug was to blame. In all of 2007, the agency received 100 reports of problems with the drug. Nearly all of the 450,000 people in the United States on dialysis need copious doses of heparin.
Heparin is also used in cardiac surgery and among chronic care patients. Dr. Ajay Singh, director of dialysis at the Brigham and Women’s Hospital in Boston, referred to the situation as “a national security issue.” The FDA had not ordered a total recall of the shipped drug as it was feared this might provoke a serious national shortage. Baxter supplies half of the total U.S. demand for heparin. The FDA has suggested that health care professionals give their patients steroids or antihistamines in combination with heparin to prevent allergic reactions.
According to Representative Bart Stupak, Democrat of Michigan and chairman of a House investigative subcommittee, the FDA has been unable to provide basic information about the Chinese manufacturing plant weeks after concerns were first raised was deeply troubling. “They can’t tell us if they’ve inspected this plant, what other problems might have been identified at this plant, or what other U.S. firms might be getting supplies from this plant,” he said.
Over the past year, a wave of tainted goods from China, including deadly pet food ingredients, children’s toys with paint containing dangerous levels of lead, and tainted fish, has prompted concern about whether regulators are adequately monitoring imports’ safety.
The Government Accountability Office (“GAO”) released three reports in recent months that found that the drug agency provided little oversight of the increasing number of foreign plants that export food, drugs and devices to the United States. Although the agency must inspect domestic drug plants once every two years, the investigators found that it inspected foreign drug plants at best once every 13 years.
The agency’s record in China is even worse. Of the 700 approved Chinese drug plants, the agency has been able to inspect only 10 to 20 each year and would need 40 to 50 years to inspect them all. The GAO said that the FDA is so understaffed, it would take the agency at least 27 years to inspect every foreign medical device plant that exports to the U.S. and 1,900 years to examine every foreign food plant.
China has become the world’s number one supplier of pharmaceutical active ingredients. China has also entered a market, the production of generic drugs, which to date has been India’s domain.
The FDA and Chinese authorities (SFDA) have, since December, 2007, been working towards achieving better quality control procedures for drugs produced in China for the U.S. market. The FDA would like to be able to make unannounced inspections of Chinese plants that supply the US market – surprise inspections. At present a plant in China knows well in advance of an FDA inspection.
In 2007 the head of China’s SFDA was executed for corruption – taking bribes to approve drugs. Scientific Protein was founded by the meat-processing giant Oscar Meyer Foods in 1976 to make products from animal byproducts, including heparin, derived from animal organs.
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