Officials Question Safety Of Overseas Drug Manufacturers
-NBC News
04/02/2008 - Heparin is a drug used - safely - by millions of Americans to prevent blood clots. It's been around for decades. But recently, a bad batch of Heparin made hundreds of people sick and killed 19 of them. The batch contained a contaminated ingredient that's still under investigation. It was made in China. And D.C. Pharmacist Harold Kramm said it was no surprise. "The FDA is supposed to check these things, but they can't check them all," Kramm said.
Kramm said in the 45 years that he's owned Center Pharmacy in Northwest Washington, more and more of the drugs sitting on store shelves are being manufactured in other countries. Places like India, Europe and the Carribbean. News4 took a look at the five most commonly prescribed drugs, cholesterol lowering Lipitor, narcotic pain reliever acetominiphin with hydrocodone, antibiotic amoxicillen and high blood pressure fighters, Toprol-XL and Norvasc. Three of those top five were manufactured overseas. "FDA simply does not have the people to go to these foreign countries and inspect these faciltities," said former FDA Associate Commissioner William Hubbard. Hubbard said contamination issues like what happened to Heparin are far from over. That's because the regulatory agency doesn't have the resources to inspect the thousands of manufacturing facilities around the globe. But according to a recent federal audit, the problems go deeper than that. A November 2007 Government Accountability Office report showed that the FDA doesn't even know how many of these plants are importing drugs and drug ingredients into the U.S. Agency officials couldn't give an exact number of foreign manufacturers, saying there were between 3,000 and 6,800. These companies make 80 percent of raw material used to manufacture the drugs that are sold in the U.S. So even if the drug is made in the U.S., the ingredients in that drug could still be made overseas. And according to that same report, these facilties are inspected, on average, once every 13 years. FDA officials would not comment on this report. "The U.S. manufacturers are being inspected every two years, but the foreign manufacturers are not being inspected and that's a real disconnect," Hubbard said. "We're inspecting where the drugs aren't being made and not where the drugs are being made." "This is everybody's nightmare come to life," said Public Citizen's Peter Lurie. Lurie said consumers have cause for concern. Most people don't have access to the manufacturer information, and even if they did, they 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 thay are not." The FDA would not comment on any of these issues. Last week, agency officials announced plans to open eight new offices around the world, the first one being in China. A spokesman for Heparin's Manufacturer, Baxter Healthcare, told us that the company is forced to manufacture the drug's active ingredient in China because of U.S. manufacturers can't meet the huge demand for the drug. And two weeks ago - New York Sen. Charles Schumer announced legislation to force the F.D.A to inspect overseas facilties more often.
If you or a loved one have experienced Heparin Sodium Injection side effects you may be entitled to compensation. Contact the Heparin attorneys of Ennis & Ennis today for a free confidential case evaluation. Our on staff nurse and lawyers are standing by to answer any questions you may have regarding Heparin side effects, a possible Heparin class action lawsuit, or any other type of Heparin Sodium Injection litigation. |
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