U.S – The U.S. Food and Drug Administration (FDA) has named Michael C. Rogers as the permanent Associate Commissioner for Regulatory Affairs (ACRA) in the FDA’s Office of Regulatory Affairs (ORA).
With a distinguished 32-year career with the FDA, Mr. Rogers brings extensive experience to this pivotal role.
ORA is the lead office for all agency field activities. It inspects regulated products and manufacturers, conducts sample analyses of regulated products and reviews imported products offered for entry into the United States.
Michael C. Rogers, a former FDA investigator based in Baltimore, is no stranger to the FDA, having spent 28 years of his 32-year career with the Office of Regulatory Affairs (ORA). His familial connection, as the son of a former ORA District Director, adds a unique dimension to his legacy of service.
Mr. Rogers has a wealth of experience in leading boots-on-the-ground inspections of food, drug, and other medical product facilities both in the U.S. and internationally. His journey includes roles as an investigator, supervisory investigator, Deputy Director for ORA’s Office of Regional Operations, and Director of the Division of Field Investigations.
In 2011, Mr. Rogers assumed leadership in Costa Rica as the head of FDA’s Latin America Regional Office. In this capacity, he oversaw products produced in 44 countries and territories in Latin America and the Caribbean for the U.S. market.
His international experience includes collaborating with foreign governments, leading investigations, and supporting responses to public health emergencies.
Michael C. Rogers has conducted inspections in diverse settings, including high-profile clinical trials, animal testing facilities, pharmaceutical companies, food facilities, and large blood banks. His career highlights feature collaborations with foreign governments, development of international agreements, and contributions to public health-related emergencies and natural disaster recovery efforts.
Strategic priorities at the helm
As the new ACRA, Mr. Rogers steps into a pivotal role during a crucial juncture in the organization’s history. His top priorities include foodborne illness prevention, harnessing AI tools for targeting unsafe foods entering the U.S., combatting health fraud, addressing the opioid crisis, expanding partnerships at various levels of government, and setting global standards in public health-protecting field operations.
Michael C. Rogers assumes leadership at a time when the FDA faces multifaceted challenges, requiring a comprehensive and forward-looking vision.
His decades of experience and commitment to public health make him well-suited to steer critical initiatives and collaborations that contribute to the safety and well-being of the public.