Keagan Lenihan became the Chief of Staff of FDA in June of 2019, and oversees the daily management of the Agency and leads the Agency’s activities on major initiatives. She provides strategic direction to senior leadership to advance FDA’s policy priorities, including efforts to promote medical product innovation, pursue a comprehensive plan for tobacco regulation, improve drug competition, fight the opioids crisis, and strengthen our food safety system. Mrs. Lenihan works closely with the leadership of all FDA product centers and field operations to support their implementation of Agency policies. She also serves as the Commissioner’s direct liaison to other executive Agencies and organizations and engages across government on critical public health initiatives. In addition, she plays a key role in legislative engagement, communications, and stakeholder outreach.
Prior to her role as Chief of Staff, Mrs. Lenihan served as the Associate Commissioner for Strategic Initiatives and External Affairs within the Office of the Commissioner at the U.S Food and Drug Administration (FDA) where she focused on priority projects across the agency, Department of Health and Human Services (HHS), Executive Offices of the President (EOP) and entire U.S. Government. In this role, she advanced our work in opioids, drug shortages and other strategic initiatives as well as advanced the FDA’s communication portfolio through stakeholder engagement and assisting with collaborations with Federal partners. She also managed media affairs, internal communications, FDA Voices, the agency’s website and the work underway to enhance our web presence.
Prior to her time at FDA, Mrs. Lenihan served as the Senior Counselor to the Secretary of HHS where she focused on drug pricing reform initiatives, reduction in patient and provider regulatory burden, price transparency and patient empowerment, The Office of Health Reform, and assisting with the Center for Medicare and Medicaid Services (CMS) portfolio. Prior to entering the Administration, Mrs. Lenihan was in the private sector for five years as an executive with McKesson Specialty Health managing federal government relations. She spent nearly a decade on Capitol Hill working for three Members of Congress in key leadership positions as well as the House Rules Committee staff. Mrs. Lenihan received her degree from the University of Colorado, Boulder; and resides with her family in Virginia.