Merck Vioxx Communications With FDA Questioned By Senate Finance Cmte.
This article was originally published in The Pink Sheet Daily
Executive Summary
Sen. Grassley (R-Iowa) asks Merck to provide copies of its communications with FDA relating to Vioxx. The Finance chair is concerned about a possible “agreement” that may have allowed Vioxx to remain on the market longer than it would have otherwise.
You may also be interested in...
Sen. Grassley Seeks FDA Documents On Vioxx Labeling Changes
Senate Finance Committee chair questions why FDA did not adopt recommendations by a cardio-renal division medical officer that a cardiovascular warning be added to Vioxx labeling. Grassley calls FDA’s drug safety initiative “welcome, albeit late in coming.”
Sen. Grassley Seeks FDA Documents On Vioxx Labeling Changes
Senate Finance Committee chair questions why FDA did not adopt recommendations by a cardio-renal division medical officer that a cardiovascular warning be added to Vioxx labeling. Grassley calls FDA’s drug safety initiative “welcome, albeit late in coming.”
FDA Sought To Suppress Vioxx Safety Data, Sen. Grassley Says
Based upon Finance Committee investigators’ interview with FDA Office of Drug Safety’s David Graham, Grassley maintains the agency delayed presentation of a study that found an increased cardiovascular risk associated with Vioxx.