A new study shows major problems with the quality of drugs sold in the United States.
"Concerns about U.S. drug quality are increasing," the study's authors write in a guest commentary for
Forbes.
"With 80 percent of the ingredients and 40 percent of the final products coming from overseas (notably India and China), the U.S. Food and Drug Administration (FDA) faces a daunting task to ensure drug quality."
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The authors are Roger Bate, a visiting scholar at the American Enterprise Institute; Aparna Mathur, an AEI resident scholar; and Ginger Zhe Jin, a University of Maryland economist.
They note that the FDA has made many warnings to multiple companies on issues ranging from data manipulation to sanitation.
In an examination of 1,437 samples of ciprofloxacin from 18 low-to-middle-income countries, the three economists found that 9.9 percent of samples failed quality tests, and 41.5 percent of the failures were falsified, which means the drug samples had zero correct active ingredient.
"Our findings highlight a delicate tradeoff between drug quality and drug cost," the trio writes.
"Banning low-priced substandard products has to be addressed carefully, since these products may be the only ones the poorest can afford. . . . On the other hand, maintaining minimum standards is important," they add.
"A more overt understanding of the dynamics of this dilemma is needed before policy makers commit to extra drug regulations in and out of the U.S."
In an example of the problem, the FDA says that officials at the U.S. subsidiary of Wockhardt, an Indian drug manufacturer, utilized an unapproved testing method for drug quality,
The Wall Street Journal reports.
As a result, the FDA already has banned imports from two of Wockhardt's Indian plants.
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