Regulatory Focus™ > News Articles > Ireland, FDA's Legislative Director, Transitions to new Advisory Role Within Agency

Ireland, FDA's Legislative Director, Transitions to new Advisory Role Within Agency

Posted 05 November 2012 | By Alexander Gaffney, RAC

The US Food and Drug Administration's (FDA) top legislative official, Jeanne Ireland, will leave her current post and assume a new role as senior advisor to Commissioner Margaret Hamburg, the commissioner wrote in an email to FDA staff on 1 November.

Ireland served since 2009 as the head of the Office of Legislation (OL), an office charged with coordinating legislation and working with legislators to defend the agency, advocate on its behalf and advise members of Congress on current issues.

Ireland's new role will have her managing "high priority projects" for the agency, said Hamburg. In the interim, she will also continue to coordinate the agency's response to the recent meningitis outbreak, including pharmaceutical compounding issues in general.

The transition comes just months after Ireland helped to oversee the legislative process for the FDA Safety and Innovation Act (FDASIA), as well as some high-profile skirmishes with legislators. In July 2012, for instance, Ireland fired back at legislative reports from the House Oversight Committee that indicated FDA was to blame for escalating drug shortages. In a separate instance, Ireland also helped to coordinate the agency's response to a lawsuit by former employees of FDA, saying a program used to monitor employee activities had been shut down.

"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," explained Hamburg. "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."

Ireland came to FDA from the House Energy and Commerce Committee, where she served as a public health advisor for Rep. John Dingell, then chairman of the committee. Before then, she worked in various capacities for the Elizabeth Glaser Pediatric AIDS Foundation, the Robert Bosch Foundation, and the Senate's Health, Education, Labor and Pensions (HELP) Committee.

Ireland will be replaced on an interim basis by Michele Mital, who currently serves as a senior advisor within OL.

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