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Disputing Study, U.S. FDA Says Generics From Abroad Safe

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Generics are safe: FDAA top U.S. regulator is discrediting research published a year ago that found impurities in dozens of generic heart drugs made overseas, saying the investigators contaminated the samples during their testing.

The study by Preston Mason, a researcher at the Harvard-affiliated Brigham & Women’s Hospital in Boston, was one of the first independent probes into generic heart drugs. Outlined by Mason at a congressional briefing last month, it has been at the center of a growing debate over the quality of copycat drugs as insurers increasingly demand their use to trim medical costs.

Janet Woodcock, the Food and Drug Administration’s lead drug reviewer, said Mason’s team “didn’t use the proper method to extract the active ingredient” from samples “and therefore contaminated it themselves.” Mason defended his work, saying he used the same method on all of the drugs, and only the foreign-made ones had high levels of contaminants. Tests on Pfizer Inc. (PFE)’s Lipitor found very low levels, he said.


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