Acting FDA Commissioner Stephen Ostroff to Speak at RAPS' Regulatory Convergence

RAPSRAPS' Latest | 18 June 2015 |  By 

Acting Commissioner of the US Food and Drug Administration (FDA) Stephen Ostroff, MD, will speak to attendees of the 2015 RAPS Regulatory Convergence. RAPS’ signature annual event for the regulatory profession will take place 24–28 October in Baltimore. Ostroff will speak 27 October, delivering a special keynote address, then he will participate in a panel discussion on key agency activities and initiatives. Other expert panelists are expected to be announced in the coming weeks.

Ostroff stepped in as acting FDA commissioner in April following former Commissioner Margaret Hamburg’s resignation after serving in the post for nearly six years. Previously, Ostroff had been FDA’s chief scientist, working closely with FDA’s product centers to support the use of sound regulatory science throughout FDA activities.

He joined the agency in 2013 as chief medical officer in the Center for Food Safety and Applied Nutrition and senior public health advisor to FDA’s Office of Foods and Veterinary Medicine. Before FDA, Ostroff was deputy director of the National Center for Infectious Diseases at the Centers for Disease Control and Prevention.

Ostroff has a strong track record as a committed scientist, and has pledged to build on Hamburg’s work to ensure a solid scientific basis for FDA’s work. Speaking to the Food and Drug Law Institute a few weeks after taking over as acting commissioner, Ostroff said: “We do our best when we go where the science leads us, and base our decisions on thorough, data-driven analyses. This assures our work will benefit patients and consumers. If we cut corners with the science, ultimately patients and consumers are shortchanged. There will be no change with [Margaret Hamburg’s] departure regarding this central role of science-based decision making during my watch.”

It is unclear whether President Obama will nominate Ostroff or anyone else to be FDA’s permanent leader before he leaves office in January 2017. For the time being Ostroff’s appointment seems to be aimed at maintaining continuity of the momentum of Hamburg’s tenure, which has been widely viewed as successful.

It may be seen as fitting for Ostroff to address RAPS members this year, as his predecessor Hamburg had done back in 2009, not long after taking over at FDA. Back then, addressing RAPS members gathered in Philadelphia, she touted the need for what else? Better regulatory science.

For more information on the 2015 RAPS Regulatory Convergence, including the full agenda, session information, speakers and more, visit


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