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FDA Inspections of Foreign Drug Makers Still Lacking, GAO Audit Says

Apr 22, 2008 | Parker Waichman LLP

The Food & Drug Administration (FDA) is inspecting more foreign drug makers than it once did, but is still only conducting a fraction of the reviews necessary to keep consumers safe from defective drugs, a new audit has found.  Concerns about the FDA's oversight have intensified in recent months, following the discovery that heparin ingredients made in China may have been responsible for dozens of deaths and hundreds of illnesses in the US.  Investigations into the heparin debacle revealed that, due to a computer error, the Chinese plant that made the active ingredient for Baxter International's recalled heparin had never been inspected by the FDA.

The results of this new audit are similar to a report filed by the Government Accountability Office (GAO) in November, which 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 did visit foreign plants, officials provided advance warning and rely on translators supplied by the companies being inspected, clearly a conflict of interest that compromises the integrity of the inspections. The report was alarming, considering the fact that about 40 percent of pharmaceuticals and 80 percent of the chemical ingredients in drugs are imported, and a growing share come from countries like China, that are still working on implementing a product safety infrastructure.

Now, the GAO has released a new audit of the FDA's overseas policing efforts.  According to the audit, the FDA increased inspections of foreign manufacturing sites to about 11 percent last year and took other steps in recent months, but made limited progress overall.  The GAO estimated it would cost between $67 million and $71 million to inspect all 3,200 foreign sites every two years. The FDA has only proposed spending about $11 million on foreign inspections in fiscal 2008, the GAO said.

The consequences of the FDA's failure to keep tabs on foreign drug suppliers were made all too apparent by this year's heparin problems.  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 total, the FDA said tainted heparin has been identified in a 12 countries. The FDA has said tainted heparin has been implicated in 82 US deaths.

In March, the FDA confirmed that it had found oversulfated 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 Scientific Protein Laboratories. The Chinese facility had never been inspected by the FDA because of a computer glitch that led agency personnel to believe it had been reviewed.  Once the heparin problems became apparent, the FDA did send inspectors to the plant who reported that conditions there did not meet US good manufacturing practice standards.

A House of Representatives subcommittee is set to question FDA Commissioner Andrew von Eschenbach about foreign drug inspections at a hearing today where representatives from the  GAO will appear also  to discuss the recent audit.


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