Yesterday the FDA announced with a press release that Dr. Janet Woodcock was being named the permanent head of the Center for Drug Evaluation and Research (CDER). If upon receiving this news, you had the most profound sense of deja vu, it is because this is not the first time. If you remember back to 1994, the FDA also issued a press release announcing that Dr. Janet Woodcock was being appointed the permanent head of CDER.
There is no doubt that Dr. Woodcock is highly credentialed and a respected and long history with FDA and was head of CDER during the FDA’s more golden age. She understands the practical realities of drug approval and I’m sure grasps the current political environment and what it means for this division and for the agency. Last August, I had the pleasure of interviewing her in a podcast about adaptive clinical trial design.
The odd thing about the most recent press release is that it paid a glancing mention that she formerly headed CDER, which she led for 9 years! Not exactly an insignificant thing to mention, particularly if the object of the appointment is an attempt to restore some of the lost confidence in the agency, the approval process and post-marketing surveillance. These would be tough shoes to fill, but if I were FDA, I would leverage every potential for re-gaining public confidence.
