Changes At FDA But Not In Priorities, Says Henney

Jane Henney's priority as US Food and Drug Administration Commissioneris the full and effective implementation of the FDA Modernization Act, she told the annual meeting of the US Food and Drug Law Institute last week, just one day after taking the oath of office.

While noting that it was too early for her to make policy pronouncements or predictions, Dr Henney told the meeting that it was good to be "recalled." The FDA is much different to when she was last there in 1994, and some of its processes have changes as a result of FDAMA and RE-GO (reinventing government), she noted, but this has not changed agency priorities.

Need For FDA Leadership To "Stay Focused" Managerial experience in public health organizations is her forte, but being FDA Commissioner is about leadership. It will be for her and for the top FDA leadership to stay focused on what is important, she noted, especially implementing FDAMA, in both its spirit and letter. The agency has made remarkable progress in doing that, without additional resources and while doing its regular work, she noted, and agreed with the FDAMA directive to be in touch with agency stakeholders, as listening to this input will maximize agency effectiveness. This dialogue needs to be ongoing, she added.