Swimming the political sea with the US FDA: A fine kettle of fish?
This article was originally published in SRA
Executive Summary
What played out in the US on Capitol Hill in the aftermath of the September 2004 withdrawal from the worldwide market of Merck's Vioxx (rofecoxib) - with regulators being frequently hauled in front of congressional committees - is probably the best evidence the US Food and Drug Administration is often at the mercy of political and societal pressures.