Just a few weeks ago, it looked like FDA would finally gain a permanent commissioner after a year of waiting and that industry agreement on revised drug user fees would begin a steady march through Congress to timely approval this year. Now a range of contentious political issues have jeopardized these and other initiatives vital to the agency’s effectiveness and stature, both at home and on the important global stage. Democrats and Republicans are questioning the capabilities and credibility of Robert Califf as a leader for the agency, despite his valuable experience in biomedical R&D and as the head of FDA several years ago. Moreover, the legislators appear willing to delay action on new user fee agreements to air a broad range of grievances about agency decisions and policies.
