Ohio Senator Sherrod Brown, in a letter to the FDA, claims drugmakers are taking advantage of lower safety standards in India and China June 19, 2008, 9:51AM EST
Outsourcing has come under the US scanner once again, this time for drug manufacturing. The US Food & Drug Administration (FDA) has been asked by a US senator to probe into outsourcing of pharmaceutical ingredients.
The senator has claimed that drugmakers are taking advantage of lower safety standards in countries like China and India. The senator has also asked Pfizer, the world's largest drugmaker, for details of its outsourcing to countries without the same drug safety standards as the US.
Senator Sherrod Brown, in a letter to the FDA's Center for Drug Evaluation & Research director Janet Woodcock, referred to her testimony to the Senate Committee on Health, Education, Labor & Pensions (HELP) where she had said that drug companies outsource because of "different governmental regulations in different parts of the world", "lower, less stringent standards in some parts of the world", and lower labour costs in developing countries.
The senator has asked Dr Woodcock for details of the volume of outsourced drug ingredients, the added costs of regulating outsourced ingredients, and the 'bearer' of those costs. He has also asked for measures to hold companies accountable for outsourcing. In a separate letter to Pfizer's vice-president of quality, EHS and agility, Gerald Migliaccio, Mr Brown asked about the drugmaker's annual savings through outsourcing and a list of instances where Pfizer has outsourced manufacturing due to lack of technical expertise.
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http://www.businessweek.com/globalbiz/content/jun2008/gb20080619_732333.htm?chan=top+news_top+news+index_global+businessGo Senator Brown! :applause: