Avalanche of drugs, scarcely any oversight, II

to heparin injections were being reported at more than twenty times normal rates. Ten more days passed, though, before Baxter recalled the lots in question and FDA inspectors descended on Baxter’s U.S. manufacturing facilities. A Baxter spokeswoman declined to explain the 10-day delay.

Inside Baxter’s Deerfield headquarters, it was code red. Robert Parkinson, the company’s CEO, began holding early morning meetings with a team of key leaders: people responsible for Baxter’s drug surveillance, drug quality, legal, manufacturing, research, and regulatory affairs. After the morning meetings, Parkinson made a point of popping in on his key executives. This kept him up to speed on developments and gave people a chance to share what they had learned. One surprise: Parkinson soon learned the FDA never had inspected the China manufacturing plant. Recalling the finding in a recent Chicago Tribune interview, Parkinson sought to minimize the oversight. “It’s not unusual for us not to know that the FDA has not inspected a supplier to a supplier,” he said.

Dozens of Baxter scientists began searching for a cause of the outbreak. They deployed nuclear magnetic resonance imaging and atomic emission spectroscopy tests on the heparin itself. More mundane tests were conducted, too, on everything from water systems to processes for mixing drugs, to sterilization of equipment, to supplies such as rubber stoppers. The FDA’s study of Baxter’s domestic operation was coming up empty. FDA tests at Scientific Protein’s production plant outside Madison, Wis., also found no connection. Baxter’s scientific research kept pointing to one place: Scientific Protein’s China production plant, and the nine suspect lots it produced. By the time the FDA sent a team of inspectors to China on 20 February, Parkinson was beginning to turn his attention to Baxter’s next big challenge: getting Baxter’s version of heparin back on the market. That effort ran aground last week, though, after the initial FDA inspection results forced Baxter to recall virtually all its heparin in the United States. Baxter’s one major competitor in the heparin market, APP Pharmaceuticals of Schaumburg, Illinois, announced in mid-February it was boosting production. APP’s China supplier has passed inspections by both the FDA and China’s State Food and Drug Administration. Parkinson prefers not to emphasize the competitive dynamic, though. Instead, he focuses on the key role heparin plays as a blood thinner in kidney dialysis and heart operations. “We have, as a company, an obligation to the medical and the patient