April 14, 2021

FDA Office of Regulatory Affairs Ombuds Releases 2020 Report

Erica Katherine, the Ombudsman for FDA's Office of Regulatory Affairs, says that the annual report from her office reflects the unique challenges as the nation navigated through a global pandemic and a period of social change in 2020. The ORA Ombudsman engages with FDA’s external partners (including industry, other governmental agencies and consumers) and works to improve communications between employees and stakeholders while practicing to IOA standards. In 2020, Katherine's office reviewed and responded to 318 inquiries, a 16% increase from the prior year and the third straight annual increase. 

Although the ORA Ombuds works primarily with external stakeholders, their interactions are strikingly similar to those of other Organizational Ombuds. Nearly all cases are resolved through (in descending order): referral; provided general inquiry; facilitated dialogue; option identification; shuttle diplomacy; and upward feedback. (FDA ORA Ombuds 2020 Report.)

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