Heparin Scandal Leads to More Questions on Overseas Drug MakersApr 2, 2008 | Parker Waichman LLP
Heparin is a blood thinner is administered in surgery and other critical care areas to prevent blood clots, is crucial in dialysis and heart surgery, and is used for the bedridden. Other drugs thin blood, but their effects are as quick or as easily reversed. Heparin, which has been manufactured since 1930, is administered to millions of patients yearly and although heparin has been used safely by millions of Americans, a bad batch of the drug recently sickened hundreds and killed 19 because it contained a contaminated ingredient that's still under investigation. The batch was made in China at a plant never inspected by the US Food & Drug Administration."
Washington, DC pharmacist Harold Kramm was not surprised saying, "The FDA is supposed to check these things, but they can't check them all," adding that more and more of the drugs sitting on store shelves are manufactured in other countries like India, Europe, and the Carribbean. News4 reviewed the five most commonly prescribed drugs—cholesterol lowering Lipitor, narcotic pain reliever acetominiphin with hydrocodone, antibiotic amoxicillin, and high blood pressure fighters Toprol-XL and Norvasc—and found that three were manufactured overseas. The "FDA simply does not have the people to go to these foreign countries and inspect these facilities," said former Food and Drug Administration Associate Commissioner William Hubbard. Hubbard said contamination issues are not over because the FDA does not have the resources to inspect the thousands of manufacturing facilities worldwide.
Meanwhile, according to a recent federal audit, a November 2007 Government Accountability Office report indicated that the FDA doesn't know how many of plants are importing drugs and drug ingredients into the US. As a matter-of-fact, agency officials were unable to give an exact number of foreign manufacturers, saying there were somewhere between 3,000 and 6,800. These companies make 80 percent of the raw material used to manufacture drugs sold in the US So if a drug is made in the US, its ingredients could be made overseas. Worse, the reports states that such facilities are inspected, on average, once every 13 years.
"US manufacturers are being inspected every two years, but the foreign manufacturers are not being inspected and that's a real disconnect. We're inspecting where the drugs aren't being made and not where the drugs are being made," Hubbard said. "This is everybody's nightmare come to life," said Public Citizen's Peter Lurie. Lurie said consumers should be concerned since most people don't have access to manufacturer information, and even if they did, couldn't skip their medication. "Unfortunately, there isn't very much the consumer can do about it. You really are at the hands of the FDA, because you can't distinguish between those drugs that might be risky and those that are not."
Last week, agency officials announced plans to open eight new offices around the world, the first in China. A spokesman for heparin's Manufacturer, Baxter Healthcare, said the company is forced to manufacture the drug's active ingredient in China because US manufacturers are unable to meet the huge demand for the drugs.
Two weeks ago, New York Senator Charles Schumer announced legislation to force the FDA to inspect overseas facilities more often.