Tuesday, March 15, 2011

The Task; FDA's Overseas Inspections

The U.S. pharmaceutical industry has jumped on the outsourcing phenomenon, which in the past has posed major risks for American consumers.
According to an article in the Berkeley wellness letter; "What matters is that drugs manufactured in the U.S. are regulated according to strict standards, and manufacturing facilities undergo periodic inspections by the Food and Drug Administration (FDA), a federal agency. Canada and the European Union have their own standards, but this is not generally true elsewhere, not even Japan. Technically, the FDA is supposed to register all exporters to the U.S. and do a pre-approval inspection of any plant supplying drugs to the U.S. But that seldom happens. For one thing, products often go through many hands. The importer may not even know where they came from. In 2006, according to an article in Clinical Pharmacology and Therapeutics, the FDA inspected 212 foreign drug firms, but there are thousands more. It is a job of overwhelming proportions."

While the FDA strives to regulate the complex supply of drugs from U.S. drug manufactures, the officials also take on the seemly difficult task overseas. Pharmalot, one of my favorite blogs and maybe yours too, has put together another great article on the FDA's attempt at regulating drug manufacturing overseas. Noted by the author Ed Silverman "In China alone, the problem is daunting. There are nearly 1,000 manufacturers of drug substances eligible for FDA spection."
Global drug manufacturing has increased substantially, take a look at the Pharmalot article to gain some insight into the growing numbers and the FDA's task at hand.

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