FDA Policy/General

More ORA Changes Coming

In an update, FDA commissioner Robert Califf says additional changes will be made to the agency’s new Human Foods Program (HFP) and the Office of Regulatory Affairs (ORA) to enhance coordination, prevention, and response activities across FDA. In a media statement, Califf says the changes are based on recommendations from an internal working group and an external evaluation conducted by the Reagan-Udall Foundation. The changes are:

establishing ORA’s core mission as conducting investigations, inspections, and imports for all FDA-regulated products, with assignments in partnership with the HFP and other product programs or Centers;
merging compliance functions currently managed within ORA into the HFP and the product Centers’ existing compliance functions to streamline operations and expedite decision-making;
realigning the eight human and animal food laboratories currently managed by the ORA into the HFP to join four labs now in the Center for Food Safety and Applied Nutrition to form a unified food laboratory enterprise under the HFP;
transitioning certain functions under the Office of Security and Emergency Management to ORA;
unifying state and local food safety partnership functions and certain aspects of international food safety partnerships into an Office of Integrated Food Safety System Partnerships in the HFP;
reviewing support functions across ORA and proposing realignment of certain resources and personnel to support the changes; and
prioritizing recruitment, retention, and training opportunities for field-based employees.

Califf says the agency is in the final stages of recruiting a deputy commissioner for human foods and has started a recruitment process to fill the position of associate commissioner for regulatory affairs.

Earlier this year, Califf said his “transformative vision” for the HFP and ORA would give both organizations “clear priorities that are focused on protecting and promoting a safe, nutritious U.S. food supply that more quickly adapts to an ever-changing and evolving environment.” At that time, he said ORA would become “an enterprise-wide organization that supports the Human Foods Program and all other FDA regulatory programs by focusing on its critical activities.”

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