Biodefense and food supply safetyAvalanche of drugs, scarcely any oversight, II
About $72 billion in drugs and active ingredients were imported into the U.S. in 2006; the FDA that year spent a mere $12.75 million inspecting foreign production plants; between 3,250 and 6,800 non-U.S. plants export drugs and drug ingredients to the U.S.(the FDA’s two main databases each gives a different figure), and are thus subject to FDA inspection; in the last five years the agency has conducted only 1,445 foreign inspections; main reason: In the face of growing drug and food imports, the Bush administration steadily cut the agency’s budget and resources since 2001
Yesterday we wrote about the growing discrepancy — a yawning gap —between the sheer amount of drug and food imported into the United States, and the resources available to the Food and Drug Administration (FDA) to inspect these imports and the companies which manufacture them to make sure they meet U.S. safety and health standards. Instead, U.S. drug companies, battling mightily to protect public health and their corporate reputations — and congressional pressures — often step in where FDA inspections have not. The Chicago Tribune’s David Greising and Bruce Japsen write that Baxter, for example, attempted to do so: In September 2007 a Baxter team visited the Chinese plant from which it was buying herapin. By that time, though, timelines produced by Baxter, the FDA, and the Centers for Disease Control and Prevention (CDC) show the suspect heparin already was making its way through the Baxter supply chain. The production line stretches from Baxter’s Deerfield, Illinois headquarters, to Scientific Protein’s offices in Waunakee, Wisconsin, to Changzhou, China, and back to Cherry Hill, New Jersey, where the heparin produced by Scientific Protein is processed, poured into bottles, and shipped to hospitals around the country.
Greising and Japsen write that the lure of inexpensive and plentiful supplies prompted Baxter three years ago to give the go-ahead to longtime supplier Scientific Protein when the company said it was converting a Chinese pharmaceutical plant to U.S. standards. After the Baxter inspection team visited the plant in September and delivered a positive report, all seemed to be in order. Then, in late December, the troubles started. Reports from hospitals showed a spike in allergic reactions to one dosage strength of multidose vials of the clear liquid drug. The reactions were particularly aggressive: More than 40 percent of the patients with ill effects were classified as serious — meaning death was a possibility. At first, the reports were confounding. Besides the on-site inspection, Baxter also routinely tested heparin that traveled from China to its Cherry Hill processing plant. Those tests showed no difference between vials connected to the allergic reactions and the rest of Baxter’s production of some 100,000 injection vials a day — roughly half of the U.S. supply of that dosage. By the time the St. Louis Children’s Hospital alerted the CDC in early January, though, investigators at Baxter and the FDA had zeroed in on nine suspect lots of the product. Adverse reactions
