Dear FDA Colleagues:
I would like to make you all aware of an upcoming transition within the Office of the Commissioner. Effective November 5, 2012, Jeanne Ireland will be leaving her post as head of the Office of Legislation (OL) to assume a new role as Senior Advisor to the Commissioner within the immediate office. In that new role, Jeanne will manage high priority projects and, in the short term, will continue to manage the legislative/oversight issues surrounding the recent meningitis outbreak and related pharmacy compounding issues. Michele Mital has graciously agreed to serve as Acting Associate Commissioner for Legislation and will oversee and manage all other aspects of OL.
For the past three years, Jeanne has been a terrific asset to the Agency in her leadership role in OL, and she has numerous legislative successes under her belt, including most recently the sweeping Food Safety Modernization Act and the Food and Drug Administration Safety and Innovation Act, which included the reauthorization of the prescription drug and medical device user fee programs and for the first time created new user fee programs for generic drugs and biosimilars. I am sorry to lose Jeanne in this important role, but I am thrilled that she will be assisting us in her new capacity. I therefore would like to congratulate and thank Jeanne for her prior achievements and to welcome her to the immediate office. I also would like to thank Michele for taking the reins in OL.
Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs