Four people have died after receiving the popular blood-thinning medication heparin, while others have suffered severe and life-threatening allergic reactions. But when drug maker Baxter International Inc. announced that it suspects a Chinese manufacturing plant of being the source of contamination that led to the reactions, the FDA admitted that it has never inspected that particular factory.
Baxter stopped manufacturing certain varieties of heparin after receiving reports of allergic reactions that included nausea, breathing trouble, and rapid, life-threatening drops in blood pressure. All the reports were associated with the high initial doses given to patients about to undergo procedures such as dialysis or heart surgery.
In addition, four people taking the medicine have also died this year, out of a total of 350 adverse reactions to the drug. According to the FDA, the deaths do not appear related to the recent allergic reactions, because they did not happen after high initial doses.
Heparin is already known to have dangerous side effects including blood clotting and bleeding, and long-term use can even lead to hair loss and osteoporosis. In 2006, three premature infants were killed when a hospital accidentally gave them a lethal dose of the drug.
The Chinese manufacturing plant that makes heparin's active ingredient, an enzyme found in pig intestines, is being investigated as a possible source of the allergies, although Baxter was careful to note that it is still unclear whether the plant or even the active ingredient are responsible for the reactions. The company said that it had inspected the Chinese plant less than six months ago, and that it always tests the active ingredients of its drugs as part of the manufacturing process.
"We are aggressively investigating the cause of the increase in adverse reactions," a company spokesperson said.
But while Baxter has inspected the plant, which has been shipping the drug to the United States since 2004, the FDA admits that it has never done so.
"While no inspection of the facility has been conducted to date, preparations are being made to perform an inspection as soon as possible," the agency said. "We have already requested expedited access to the facility, facilitated through a recently assigned agreement with the Chinese State Food and Drug Administration."
The FDA noted that it would be investigating why it had failed to inspect the Chinese plant before this. It said that one factor appeared to be the fact that the plant's name, Changzhou SPL, was similar to the name of a different drug manufacturer that the agency had already inspected.
China is the world's largest manufacturer of active drug ingredients, and a major exporter to the United States of all kinds of products. But recent safety recalls of Chinese toy and food imports have drawn attention to the need for tighter inspections.
The FDA has come under increasing fire recently for its failure to regularly inspect foreign drug manufacturing plants. According to a report by the Government Accountability Office, the FDA only inspects about 7 percent of foreign drug factories each year. In 2007, the agency inspected only 11 Chinese facilities out of a total of 170 foreign inspects conducted.
In a letter to the FDA, Rep. John D. Dingell of Michigan blasted the agency for the "disastrous state of your agency's foreign inspection program related to pharmaceuticals." Sen. Charles Grassley of Iowa also wrote to the agency, noting that the 2007 inspection of 11 Chinese plants was actually a drop from the 2004 high of 18 inspections.