Subject: Leadership Changes in the Office of Regulatory Policy
I would like to make you aware of an upcoming important transition in CDER. Effective January 6, 2013, Jane Axelrad will be leaving her post as head of the Office of Regulatory Policy (ORP) to assume a new role, on detail, as senior advisor to me.
In this new role, Jane will serve as the Agency lead on managing policy, surveillance and enforcement, legislative, and oversight issues related to pharmacy compounding arising out of the meningitis outbreak. As time permits, she will also manage various other high-priority projects that cut across office lines.
Denise Esposito will serve as acting director of ORP until at least February 1, 2013, following which she will be leaving ORP to assume a management position elsewhere in the Agency. While Denise is serving as acting director of ORP, Nancy Hayes will serve as acting deputy director. When Denise leaves for her new position, Nancy Hayes will serve as acting director until the position is filled permanently.
As you know, Jane has been the associate director for policy, CDER, for more than 20 years, and she has led ORP for more than 15 years. Jane’s expertise on various legislative and policy issues is well recognized, and she is much sought after on a variety of matters.
Because her involvement in pharmacy compounding will take up most of her time, she has expressed the desire to step out of the management of ORP so that she will be able to devote the necessary time to compounding and other policy projects. With Denise’s impending departure, I want to establish a plan during this transition to ensure the continued stability of ORP, which performs so many vital functions for the Center.
Denise has been with CDER for two and a half years, and she has made important contributions on a number of different issues, as well as serving as Jane’s deputy during this time of intense activity in CDER. We are grateful that we will still have the benefit of her skills and expertise at FDA.