A Chinese plant never inspected by the FDA turned out an active ingredient in the heparin vials recalled last month. The Baxter-made blood thinner has been implicated in hundreds of adverse reactions and four deaths. Now the FDA is investigating, planning an expedited examination of that plant and its records.
Baxter last year inspected the plant and a U.S. finishing facility that also handled the ingredient. As part of its internal investigation into the heparin problems, the company will re-inspect both facilities soon. The plant should have been checked out by the FDA before products made there were sold in the U.S.
Earlier this week, Baxter said it was suspending production of the injectable heparin, and the FDA told doctors to switch to other meds. The drug's active ingredient may or may not have triggered the intense side effects, but it's one avenue that has to be investigated, a Baxter spokeswoman said.
Even if the Chinese facility isn't fingered, the scenario is emblematic of the FDA's current shortcomings. As government reports and Congressional hearings have made clear recently, the agency's foreign oversight is worse than bad. As the Wall Street Journal notes, China is now the world's largest producer of active pharmaceutical ingredients. How many food and drug problems have to arise before FDA gets the funding it needs--and makes the internal changes required--to ensure product safety?
Baxter stops making multidose heparin. Report
Baxter recalls heparin on adverse events. Report
GAO assails FDA's foreign inspections. Report
FDA can't guarantee drug safety. Report
Overseas drugmaking goes unsupervised. Report