Lawmakers say warning letter appeals process should be reviewed

FDA needs to review its enforcement dispute resolution process, two leading Republicans on the House Energy and Commerce Committee say. In a Nov. 14 letter, Joe Barton, R-Texas, and Ed Whitfield, R-Ky., ask FDA Commissioner Andrew von Eschenbach to "personally review how center directors monitor top disputes and controversies, and report back on management performance in this area and whether any further steps or actions will be taken to improve dispute resolution and priority setting of enforcement resources." Barton, the ranking Republican of the full committee, and Whitfield, the ranking member of the subcommittee on oversight and investigations, first inquired into FDA's warning letter appeals process in an April letter to von Eschenbach in response to the agency's actions against Colorado dental implant company TMJ Implants ("The Silver Sheet" May 2007)