Generics may be bio-equivalent of brands, but are they as safe?
December 5th, 2008 by Jennifer Walker-Journey
Clinical tests conducted by the Journal of the American Medical Association comparing brand and generic cardiovascular drugs show that generic drugs are bio-equivalent to the drugs they are patterned after. And, the FDA adds, generics are far less expensive than brand-name drugs. However, U.S. News & World Report raises questions about the quality of the generic drugs.
First, researchers noted that the evaluations were short term and that many of the studies were supported by the generic drug companies, who have a vested interest in the positive outcome of the results.
Furthermore, the story points out that generics are more likely to be made in factories in other countries where labor and overhead are far less expensive, such as India and China. In fact, China is producing more and more generic drugs and, according to the story, is expected to offer even lower prices in the future.
This should raise concerns with the general public, given the tainted heparin scandal earlier this year that killed more than 80 Americans and sickened hundreds more. That tainted heparin was traced to manufacturing plants in China and resulted in a major recall of the blood thinner.
The FDA is hoping to give more guidance on U.S. quality control standards on imported food and drugs by opening offices and placing regulators in foreign countries. The first office opened in Beijing last month. However, congressional investigators say that inspecting the more than 3,000 drug plants in other countries could take more than a decade.
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