US FDA asked to check on drug outsourcing

29 June 2008

The US Food and Drug Administration has been called upon by Senator Sherrod Brown (Democrat, Ohio) to investigate whether US drugmakers are outsourcing some of their production facilities, in order to take advantage of less stringent safety regulations in other countries. Sen Brown especially asked about the activities of the leading global drug major, Pfizer, and standards in China and India. In April this year, Gerald Migliaccio, the firm's vice president of Quality, EHS and Agility, had stated that 17% of Pfizer's active ingredients and drug manufacturing is outsourced.

Sen Brown, announcing that he has asked the FDA and Pfizer to respond to his queries about safety standards in other countries, said: "it is no coincidence that drug ingredients in countries with weak safety standards are often contaminated." The Ohio Senator added: "the FDA must immediately review pharmaceutical outsourcing and make necessary changes to keep American consumers safe."

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