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No such thing as a free expert, GAO tells FDA in heparin conflict of interest case

This article was originally published in Scrip

Executive Summary

A new code of conduct introduced by the US FDA after extended criticism of the agency's response to the 2008 heparin crisis will alter the way the FDA interacts with industry personnel who volunteer help and advice to deal with "emergencies" such as suspected drug contaminations. A Government Accountability Office (GOA) report released last month claims that the FDA did not recognise or did not respond properly to the potential conflicts of interests that arose from its working with industry-associated personnel. The GOA recommended that the FDA needed to tighten its paper trail under such circumstances, and the agency responded by amending its staff guidance notes with a section on "External Expert Gratuitous Services in an Emergency".


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