A 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 & Womenâ€™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 Administrationâ€™s lead drug reviewer, said Masonâ€™s team â€śdidnâ€™t use the proper method to extract the active ingredientâ€ť from samples â€śand therefore contaminated it themselves.â€ť 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)â€™s Lipitor found very low levels, he said.