FDA independent appeals board would be created under PhRMA reform legislation.
This article was originally published in The Tan Sheet
Executive Summary
FDA INDEPENDENT APPEALS BOARD WOULD BE CREATED under draft legislative language being circulated by the Pharmaceutical & Research Manufacturers of America. The PhRMA proposal suggests that the HHS secretary would be directed to establish standing panels of non-government experts "for the purpose of hearing appeals by individuals who have exhausted their informal appeals within FDA and wish to contest the action or failure to act by FDA in a particular matter. The secretary shall establish an appeal procedure that assures immediate access to such a panel and prompt conclusions and recommendations by the panel."