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Regulators hope to improve testing of generic drugs


By Steven Ross Johnson
Posted: February 28, 2014 - 4:30 pm ET
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Federal regulators are looking to improve testing of generic medications after receiving reports of quality concerns regarding some that are produced overseas.

Issues regarding safety were reportedly raised at a briefing this week in Washington when Preston Mason, a researcher at Bingham & Women's Hospital in Boston, told government officials that some generic heart medications produced by companies based in India do not work in the same way as their brand-name counterpart. Mason, who authored a study published last year in the Journal of Clinical Lipidology that looked at 36 generic versions of the cholesterol drug Lipitor produced in 15 other countries, found impurities in many of those copies. According to the study, the impurity found had the possibility to “compromise” effective management for the treatment of hypercholesterolemia.

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According to the U.S. Food and Drug Administration, generic drugs play an important role, helping to bring down health costs, with the price of a generic drug estimated to be as much as 85% lower than that of a brand-name medication. In 2010, agency-approved generics saved consumers $158 billion.

As first reported in Bloomberg News, the FDA launched a $20 million testing program last September to address growing concerns over the safety and effectiveness of generic medications, which account for nearly 80% of the country's prescription, according to the agency.

The new program represents the first broad scale effort to test generic drugs, which had only been done on a spot check basis in the past.

Follow Steven Ross Johnson on Twitter: @MHSjohnson


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