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Substandard Rx Reaches the U.S. from China - FDA Lacks Resources

Americans take for granted that the medicines that they take when ill or being treated are not only legitimate but are also quality products. The problem is that more and more drugs being imported from countries like China and then relabeled for distribution in the U.S. Often, even when manufactured in the United States, the ingredients for these drugs are made in China. The trouble occurs because the Food and Drug Administration does not have the resources needed to inspect the plants in China where these products and/or ingredients are made to ensure that they adhere to U.S. safety standards. The result is a threat to our patient population that gets ill from the very drugs they are taking to treat an illness, or worse, die.

An investigation by the Chicago Tribune (David Greising and Bruce Japsen) revealed a quality issue with a drug called Heparin produced in one Chinese facility that no U.S. or Chinese government inspector had visited. This one plant is which is now blamed for more than 400 illnesses and potentially as many as 21 deaths in the U.S. When FDA inspectors finally went to this facility at the end of February they found evidence of poor hygiene and safety standards. Further, the inspection showed inadequate testing procedures; some tests results were missing and there was no way to actually trace the origin of some of the raw materials. The inspection also revealed that when batches of the product failed testing, workers were unable to diagnose the reasons for the failures.

Only the House Subcommittee on Oversight and Investigations of the House Energy and Commerce Committee is scrutinizing the FDA's oversight of the drug industry, and imports from China in particular and wondering if the FDA’s allowing of this plant to export to the U.S. without inspection or oversight is a symptom of a larger and much broader problem. The Chicago Tribune report suggests that the FDA’s resources make it difficult to inspect foreign manufacturing plants that send finished products or ingredients to the U.S., despite the agency’s insistence that it inspects them all.

While Congress and the GAO will now study if the FDA needs more resources to perform its role in assuring the safety of pharmaceutical products in the United States a recent FDA appointed commission concluded :

"Millions of FDA-regulated products are imported into the country each year from foreign facilities that have never been inspected by FDA and, with current appropriations, never will be," according to a report in November by the FDA Science Board's subcommittee on science and technology. The head of the FDA study group held out little hope the FDA is coming to grips with its challenges.
This is also covered here.

The FDA is charged with being our citizens’ first defense for drugs entering the U.S. The problem is that its resources are not up to the increased flow of imported products.

● the U.S. imported an estimated $72 billion in drugs and active ingredients in 2006
● the FDA spent $12.75 million inspecting foreign production plants
● approximately 3,250 non-U.S. plants were subject to FDA inspection last year, the agency has conducted only 1,445 foreign inspections in the last five years

This goes beyond the problem is dealing with counterfeit pharmaceutical products that the World Health Organization estimates represent more than 10% of all products sold worldwide. It also comes at a time when FDA drug safety warnings have dramatically increased with a total of fourteen in the three months since November, more than some entire previous years. The problem of counterfeit pharmaceuticals entering this country or being sold over the Internet is one thing. Substandard or ineffective medicines reaching the public because of an ineffective drug safety system caused by underfunding is an entirely different issue.