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FDA Not Inspecting Foreign Drug Makers Says GAO Report

Nov 2, 2007 | Parker Waichman LLP The Food & Drug Administration (FDA) inspects only a fraction of the foreign drug manufacturers who supply ingredients for medications sold in the US, and it doesn’t even know exactly how many foreign firms might be doing so.  As a result, the FDA can in no way guarantee the safety of the US drug supply. That frightening conclusion was reached following a Government Accountability Office (GAO) audit of the FDA’s foreign drug inspection practices.  

Unfortunately, the FDA is often the only defense Americans have against defective drugs from foreign suppliers.  For instance, Chinese chemical companies are rarely inspected by Chinese regulators.  Often, Chinese manufacturers produce other chemicals in addition to drug ingredients, including fertilizers and industrial solvents.  This makes it much more likely that Chinese-made drug ingredients will end up contaminated with a toxic chemical.  That is what happened in 2006, when at least 138 Panamanians died or were disabled after the poisonous ingredient, diethylene glycol, was mixed into Chinese-made cold medicine. In January, one Chinese company was accused of shipping counterfeit pharmaceutical ingredients to the US.  Yet, in 2007, the FDA was only able to inspect 13 of China’s 714 drug manufacturing facilities.

Yesterday, at a hearing of the House Energy and Commerce subcommittee that has been looking into import safety, a GAO representative said that the FDA only has inspection records for one third of the foreign manufactures that could be making drugs for export to the US.  According to the GAO, the FDA was unable to identify a previous inspection for a whopping 2, 133 facilities out of 3,249 suppliers from a list it uses to set inspection priorities.  The GAO said that at its current pace, it would take the FDA more than 13 years to inspect each foreign drug supplier once.  Yet foreign companies are allowed to manufacture about 80% of the ingredients that go into medications sold in the US.

Even when foreign companies are inspected, the GAO says that the FDA is doing a terrible job.  For one thing, the FDA has no translators on staff, so inspectors must rely on translators provided by the foreign manufacturers.  And foreign drug manufacturers are not held to anything approaching the level of scrutiny that US drug makers endure.  While domestic drug manufacturers are subject to inspection at least every two years, there is no such requirement for foreign drug suppliers.  Also, foreign drug makers are given advance notice of FDA inspections, while US companies must undergo surprise examinations.

Representatives from the pharmaceutical industry told the congressional committee that they do not rely on foreign regulators, or even the FDA, to insure that imported drug ingredients meet US safety standards.  US drug companies perform periodic inspections of their foreign suppliers and test some shipments before they enter the country.  But even they complained about the disparities between the way the FDA regulates US and foreign drug manufacturers.

The problems with FDA oversight of foreign drug makers are nothing new.   Shockingly, the GAO presented a report with similar conclusions to Congress nearly a decade ago.   Since then, the FDA has done nothing to improve its oversight of foreign drugs.   At yesterday’s hearing, FDA Commissioner Andrew von Esenbach promised that the agency has taken steps to improve its inspection system for foreign drug makers.  Despite the evidence presented at yesterday’s hearing, von Esenbach insisted that the US drug supply is safe.

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