William Hubbard, FDA's Associate Commissioner for Policy and Planning, and the FDA's authority on the topic of reimportation of pharmaceuticals, has testified a number of times before Congress regarding the dangers of reimported products and the inability of the U.S. regulatory system to assure the safety of products brought into this country. Most recently, this month before the House Committee on Government Reform, Dr. Hubbard testified (T)he overall quality of drug products that consumers purchase from United States pharmacies is very high. The public can be confident that the drugs they use are safe and effective. However, FDA cannot offer the same assurances to the public about the safety of drugs they buy from foreign sources. There are a number of reasons why these products are not safe. Counterfeiting of drugs is common throughout the world and the transshipment of these counterfeit products through Canada is one of the most serious dangers. A recent example of the dangers of counterfeiting is the FDA alert issue on May 23 of this year regarding counterfeit version of the cholesterol lowering agent, Lipitor. This product is taken by over 18 million Americans. This investigation is currently ongoing and FDA is still trying to determine the extent of this case. In March, the FDA discovered counterfeit versions of the drug Procrit which had been contaminated with bacteria or in some cases the product contained no active ingredient.
Editor's note · Context
Discussing the dangers of reimported pharmaceuticals and FDA's regulatory challenges.
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