Heparin Debacle Highlights Weak FDA Oversight of Foreign DrugsMar 3, 2008 | Parker Waichman LLP
On January 4, Dr. Alexis Elward, an infectious-disease specialist at St. Louis Children's Hospital, was the first doctor to alert the Centers for Disease Control and Prevention (CDC) regarding a rise in allergic reactions to Baxter Heparin in kidney dialysis patients. The patients’ lips and eyelids swelled, their blood pressure dropped, and their heartbeats raced dangerously after treatment with Baxter Heparin. Late February, Elward and others learned that no US or Chinese government inspectors visited the Chinese plant that produced the drug linked to over 400 illnesses and over 20 deaths in the US. By the time the St. Louis Children's Hospital alerted the CDC, investigators at Baxter and the Food & Drug Administration (FDA) had located nine suspect lots. Although adverse reactions to Heparin injections were being reported at over 20 times normal rates, it took Baxter ten days to recall the questionable lots.
Last week, FDA inspectors visited the Chinese plant owned by Baxter supplier Scientific Protein Laboratories (SPL) of Waunakee, Wisconsin where they discovered lax hygiene and safety standards; testing procedures at the plant were inadequate and—in some cases—testing records were missing and some batches were untraceable. Worse, when heparin produced at the plant did not pass quality tests, workers failed to diagnose what caused the failures and dismissed the results in some cases. A congressional committee is now wondering if the FDA's lapses are part of a larger problem.
Although drug imports increased in the past five years, inspection funds dropped. While 3,250 non-US plants were subject to FDA inspections last year, it only conducted 1,445 foreign inspections in the last five years, according to a Government Accountability Office study, significantly less than the requirement to inspect each plant every two years. It’s worse in China where the FDA averages just 15 inspections in China in each of the last five years, despite that there are 714 plants shipping drug products to the US. If China's flourishing 17 percent annual growth rate for drug exports continues, they will produce about 25 percent of the world's pharmaceutical ingredients by 2010, according to the investment firm Credit Suisse.
The FDA claims it inspects every foreign plant sending medical products to the US, but its own data contradicts this. An FDA-appointed commission that studied the agency's inspection record last fall found the FDA is short of financial resources, has cut personnel, has outdated data management systems, and is struggling to meet 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, in an interview, 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."