Biodefense and food supply safetyAvalanche of drugs, scarcely any oversight, I

Published 4 March 2008

More and more drugs are imported by U.S. drug makers from China, then re-labeled and sold in the United States; even when the drugs are made in the United States, more and U.S. drug makers purchase the drug ingredients in China; trouble is, the FDA does not have the resources to inspect these Chinese manufacturers to see whether they adhere to U.S. safety standards; the result: U.S. consumers become ill and die

By the time St. Louis Children’s Hospital called in its infectious-disease specialist on 4 January to diagnose a mysterious spike in allergic reactions to kidney dialysis, it was clear there was a major problem. Three patients had become ill after taking the blood-thinning drug heparin. One had developed the same reaction during a dialysis treatment in November. Minutes after dialysis needles punctured their veins, the boy’s lips and eyelids swelled. Their blood pressure dropped, and their heartbeats raced at dangerous levels.

The Chicago Tribune’s David Greising and Bruce Japsen write that when infectious-disease specialist Dr. Alexis Elward honed in on the problem — putting high on her list the drug made by Deerfield, Illinois-based Baxter International — she became the first doctor to alert the Centers for Disease Control and Prevention (CDC). It was not until late in February, though, that Elward and others learned that no U.S. or Chinese government inspectors had visited the Chinese plant which produced the drug now linked to more than 400 illnesses and as many as twenty-one deaths across the United States. Last week a team of Food and Drug Administration (FDA) inspectors visited the Chinese plant owned by Baxter supplier Scientific Protein Laboratories of Waunakee, Wisconsin. There they found evidence of lax hygiene and safety standards. According to the inspection report, testing procedures at the plant were inadequate. In some cases, records of testing were missing. For some batches of the product, there was no way to trace where the plant obtained its raw material, which is scraped from the mucous lining of pig intestines. One of the more worrisome findings: When heparin produced at the plant did not pass its quality testing, plant workers failed to diagnose what caused the failures. On two lots that failed tests, plant workers simply — but incorrectly — dismissed the results as “outliers.”

Now a congressional committee is asking whether the FDA’s lapse in allowing a plant it never inspected to export to the United States is part of a larger problem of poor oversight and a shortage of resources at the agency. And Baxter itself is scurrying to learn what went wrong. “My hope is, after this investigation, there will be additional checks and balances put in the system,” Elward said. “My hope is that this investigation will lead to changes in the process to be sure that inspections and checks can happen.” Greising and Japsen write that a close look at the FDA’s resources and inspection record paints a picture of an agency struggling to keep pace. Its officials insist the agency inspects every foreign plant sending medical products to the United States, but the agency’s own data make it appear unlikely. An FDA-appointed commission which studied the agency’s inspection record last fall found the FDA is short of financial resources, has cut personnel, has rickety data management systems and is struggling to meet its oversight obligations. “Millions of FDA-regulated products are imported into the country each year from foreign facilities that have never been inspected by FDA and, with current appropriations, never will be,” according to a report in November by the FDA Science Board’s subcommittee on science and technology. The head of the FDA study group held out little hope the FDA is coming to grips with its challenges. The heparin case is a warning signal, said Gail Cassell, vice president of scientific affairs at drug giant Eli Lilly & Co. “Unless the deficiencies can be addressed rather urgently, this is not the last such situation,” said Cassell. “We will have more of them.”

Where the FDA is not keeping up, private industry has become a de facto self-regulator.

Tomorrow: What private industry does, and does not do, to safeguard drugs and drug ingredients