FDA reviewer slams study that questions generic drug quality

March 28, 2014

A senior official with the U.S. FDA has slammed research that suggests many heart drugs produced outside the U.S. contain impurities.

A study released last month suggested that many heart drugs produced outside the United States contained impurities that may undermine their effectiveness. Carried out by Preston Mason, a researcher at the Brigham & Women's Hospital in Boston, the study sparked debate over the quality of generic drugs imported into the United States. But a senior official with the U.S. Food and Drug Administration (FDA) has slammed the research, claiming that Mason and his team did not use proper methods to examine the active ingredients and "therefore contaminated them themselves."

Janet Woodcock, the FDA's lead drug reviewer, commented that the agency will soon publish a new study in which a different method to test generic heart drugs was used. It did not find any contaminants in drugs manufactured in the United States, Canada, India and Slovenia that were obtained from a random retail pharmacy, Bloomberg BusinessWeek reported.

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Meanwhile, Mason defended his findings, claiming that if the problem was in the method he used to extract the active ingredient from heart drugs, all samples would have revealed contamination and not just those manufactured overseas. Speaking to BusinessWeek, Mason pointed out that when contaminants are present in low levels they are not likely to cause a problem, but when there is a larger amount of them they may alter the drug's effectiveness and interfere with treatment.

Bloomberg reported that 67 million prescriptions for Lipitor and its generic versions — the drugs that Mason's study looked into — were written in 2013.