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FDA Needs to Team Up With Other Developed Countries to Inspect Drug-Making Facilities

Posted on April 12, 2012

A report commissioned by the U.S. Food and Drug Administration (FDA) has recommended that the agency should team up with other developed countries to inspect drug-making facilities in countries like China and India.

The report, by the Institute of Medicine (IOM), revealed that when it came to regulating the manufacture of drugs and active ingredients, developing countries lack the advanced technological systems to effectively police the facilities that produce them.

Currently, more than 40 percent of finished drugs in the U.S. are imported and 80 percent of active ingredients in pharmaceuticals are produced overseas. The report reinforced FDA concerns that many of these facilities go uninspected which increases the risk of ineffective and dangerous drugs being imported into the U.S.

The IOM report suggested that the FDA should work with Canada, Japan, and the European Union to inspect facilities in the developing world. The report also recommends that an international standard for drug safety should be established and that the U.S. should build up its training of regulators here and abroad.

This report comes on the heels of reports of more counterfeit Avastin being found in the U.S. The FDA reported that the fake batches, imported from Turkey, do not contain the active ingredient of the drug that is used to treat cancers of the lung, colon, kidney, and brain.

As we have seen in the case of the drug Heparin, loose or non-existent regulation of overseas drug production can have disastrous results. If you or a loved one has been harmed due to a tainted or dangerous drug, you have the right to seek compensation. Farah & Farah’s team of Daytona Beach pharmaceutical litigation attorneys are ready to take your call at (800) 533-3555 today.