FDA Runs First Widespread Quality & Safety Evaluation on Generic Drugs

More than 80 percent of prescription drugs in the U.S. are being tested by the Food and Drug Administration (FDA) in its first widespread safety and quality evaluation. The effort will examine generic drugs such as heart medications, ADHD treatments, immunosuppressants, anti-seizure drugs and antidepressants. The evaluation will cost $20 million. It is funded through new fees collected from the generic pharmaceutical industry Congress approved in 2012.

The decision to run this first widespread test is a result of growing concerns over the quality of medications imported from other countries. The evaluation will run through 2017 and will involve dozens of academic centers across the country.

Such academic centers participating in the evaluation include Duke University, the University of Michigan, John Hopkins University, the University of Maryland, Brigham & Women’s Hospital and the University of Florida, among others.

While testing has been conducted on a periodic basis, this new evaluation reflects the FDA’s recent emphasis on the quality of “copycat drugs”, according to a Bloomberg article. Medical professionals have also become more concerned about the quality of medications manufactured overseas.

For example, a 2013 study from a Boston-based researcher found numerous problems in copies of Lipitor made outside of the United States. Manufactured by Pfizer, brand drug Lipitor lost its patent protection in November 2011, opening it up to generic competition. Up until that point, the cholesterol medication had been the world’s top-selling drug. The FDA will be reviewing the Lipitor study as part of its new safety evaluation.

Additionally, recent medical studies have linked Lipitor to a dangerous risk of diabetes in women who take the medication. In 2012, the FDA required Pfizer to update Lipitor’s warning label to inform consumers of the increased risk of developing type 2 diabetes.


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