House Republicans Challenge FDA On Warning Letter Appeal Process

摘要

Senior Republicans on the House Energy & Commerce Committee are challenging FDA on the fairness of its warning letter appeals process,questioning whether the agency "really provides a good-faith option of appeal."In an April 18 letter to FDA Commissioner Andrew von Eschenbach,Reps.Joe Barton,R-Tex.,and Ed Whitfield,R-Ky.,suggest that FDA is taking unfair advantage of a regulation that allows it to pursue enforcement action for conduct cited in warning letters while an appeal is pending before the FDA commissioner.