A former inspector with the U.S. Food and Drug Administration is speaking out about problems with facilities in India and China that produce drugs for Americans. Although he has made recommendations about cracking down in an effort to improve safety, his recommendations were ignored.
Last year, there was a huge recall of various blood pressure medications – roughly 45 recalls of generic blood pressure medications have been announced. Those medications were found to contain a carcinogen. A year before the drugs were recalled, the inspector had tried to alert the FDA about systemic problems at two facilities in China and India where the drugs were made. The FDA overruled his recommendation to crack down on one of the plants. The inspector claims that the issues at those plants were only the tip of the iceberg where manufacturing problems were concerned.
According to the FDA, roughly 85 percent of the facilities that are manufacturing the ingredients contained in American drugs are located overseas. Many of them are located in China and India, where production costs are low, and local governments do not provide strict oversight.
Another issue, according to the inspector, is that FDA inspectors are struggling to keep up with foreign drug manufacturers that may hide problems with their production. Only roughly 20 percent of manufacturing facilities abroad are inspected. The inspector claims that often, facilities and equipment overseas are not properly maintained. Impurities or anomalies in testing are not investigated.
Ultimately, American companies which distribute prescription medications are responsible for the safety of those drugs, many of which are made overseas. Making the drugs outside the U.S. typically allows them to be produced much more cheaply. If you have been harmed by a prescription drug, you should speak with an attorney.