Baxter Heparin Problems Spark More FDA CriticismFeb 15, 2008 | Parker Waichman LLP
Samples of Baxter heparin have turned up “irregularities” in the blood thinner that might be responsible for hundreds of allergic reactions in the US. Some of the irregularities found in the Baxter heparin where found in batches in which the active ingredient came from a supplier's plant in China. Yesterday, it was learned that the Food & Drug Administration (FDA) had never inspected the overseas plant that supplied active ingredients for Baxter heparin. However, Baxter Healthcare has said that it conducted its own inspection of the facility just six months ago.
Baxter recalled 9 lots of its tainted heparin vials last month, after they were linked to dozens of serious and potentially life-threatening reactions at hospitals and dialysis clinics around the country. Then, earlier this week, Baxter announced its decision to suspend heparin production until it can resolve the safety issue. The same day, the FDA warned doctors not to use Baxter heparin. According to the FDA, it has received 350 reports in 2008 of side effects linked to Baxter heparin. Four people died while taking the drug, though the agency said it wasn’t clear if the drug was to blame. In all of 2007, the agency received 100 reports of problems with the drug.
A Baxter spokesperson told the LA Times that testing had revealed ”differences between lots [of the active ingredient] but it's unclear what the impact of these differences is”. Some of the heparin samples where irregularities were found contained active ingredients supplied by Scientific Protein Laboratories of Waunakee, Wis. The firm's website says it maintains manufacturing facilities for the drug in Waunakee and Changzhou, China. Baxter maintains that the defective heparin was tested before it was shipped to hospitals and dialysis centers, and that those test fully complied with industry and regulatory requirements. But the previous tests were not as sophisticated as the tests Baxter is running now and failed to detect any possible problems with the heparin.
Yesterday’s revelation that the FDA had never inspected Baxter’s Chinese supplier has renewed criticism over the agency’s oversight of overseas manufacturers that import products to the US. According to a report released last month by the Government Accountability Office (GAO), the FDA has not been able to keep up with its inspections of overseas plants that produce foods, drugs and medical devices sold in the US. The GAO said that the FDA is so understaffed, it would take the agency at least 27 years to inspect every foreign medical device plant that exports to the US, 13 years to check every foreign drug plant and 1,900 years to examine every foreign food plant.
Several members of Congress are again criticizing the FDA, asserting that its inability to police foreign drug makers is to blame for the Baxter heparin problems. "How do you allow these drugs into this country when you don't even inspect?" asked Rep. Bart Stupak (D-Mich.), a leading FDA critic. "Where is the enforcement to make sure you are doing things right?"