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Heparin Problems Underscore FDA Failure to Regulate Foreign-Made Drugs

Apr 11, 2008 | Parker Waichman LLP Tainted heparin sourced from China has brought attention to the problems that can occur when vital drug manufacturing is moved overseas.  Heparin, contaminated with a counterfeit chemical, has been linked to 62 deaths and hundreds of adverse reactions in the U.S., and similar reactions - though no deaths - have been reported in Europe.  The heparin debacle, however, is just the latest drug safety scandal that centers on imported drug ingredients.  With more and more drug makers looking overseas for cheap manufacturing, and with a Food & Drug Administration (FDA) ill-equipped to deal with a surge in foreign drug suppliers, experts fear the situation will only get worse.

Baxter International recalled nearly all its heparin injections in the US after some patients experienced extreme - and in some cases fatal -  allergic reactions, including difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that was life threatening after being administered the products. There have been similar recalls by other manufacturers of Chinese-sourced heparin in Denmark, Italy, France Germany and Japan. In the US, heparin has been associated with the deaths of more than 100 people since early 2007, according to the FDA.  Of those, the vast majority - 62 to be exact - were associated with contaminated batches of heparin.  

In March, the FDA confirmed that it had found chondroitin sulfate in samples of the active ingredient used in Baxter heparin. The FDA said the chondroitin sulfate was molecularly changed to mimic heparin’s blood-clotting properties. That ingredient was supplied to Baxter by Changzhou SPL, a Chinese plant partially owned by Wisconsin-based Scientific Protein Laboratories LLC.  While the FDA maintains that it has not yet determined if the ingredient substitution was intentional, several sources told The New York Times that it was likely not accidental. Some heparin producers in China also sell chondroitin sulfate, which can be derived from pig cartilage. It costs a fraction of the ingredient usually used in heparin, and producers may have used it in an attempt to cut costs.

The news of heparin contamination came almost one year after some pets in the US died as the result of a pet food ingredient shipped from China that contained toxic levels of melamine, which was added to make it appear higher in protein. In Panama around the same time, 120 people died because an unlicensed Chinese chemical plant sold a cheap counterfeit ingredient, diethylene glycol, that was mixed into cold medicine imported to that country. Diethylene glycol contamination also resulted in a recall of Chinese-made toothpaste in the US over the summer.   

In March, Chinese regulators announced new restrictions on heparin suppliers, but most experts agree that while those moves are welcome, the oversight of foreign-supplied drugs remains a problem for US consumers. For one thing, the FDA is not up to the task of policing overseas drug makers.  The Chinese plant that made the tainted heparin ingredients was never inspected by the FDA, as is required by law.  Apparently, a computer error led the agency to believe it had been inspected.  

Unfortunately, that's hardly surprising.  In November, the Government Accountability Office found the FDA doesn’t know how many foreign firms are actually subject to inspection.  The agency has a list of 3,249 firms, but at the current rate of inspection, it would take the FDA over 13 years to go through each firm on its list. The agency also could not confirm how many foreign firms have never been inspected.  In those rare cases where the FDA actually does visit foreign plants, officials provide advance warning and rely on translators supplied by the companies being inspected, clearly a conflict of interest that compromises the integrity of the inspections.

No one expects improvement anytime soon.  About 40 percent of pharmaceuticals and 80 percent of the chemical ingredients in drugs are imported, according to U.S. government statistics. A growing share comes from developing countries such as China, India and Mexico that are still building their own drug safety systems. With the FDA's foreign drug oversight program in such a shambles, there are bound to be more problems with defective and contaminated drugs coming from overseas.

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