FDA Reorganizes ORA Staff, Pharmaceutical & Medical Device Update, Vol. IV, Issue III

Jones Day

On May 15, 2017, the Food and Drug Administration's ("FDA" or "Agency") Office of Regulatory Affairs ("ORA") began implementing a "Program Alignment Initiative." The Initiative requires the ORA staff, who are charged with investigating consumer complaints and inspecting domestic and foreign facilities to ensure compliance with agency standards, to specialize in specific product areas (e.g., pharmaceutical drugs, medical devices), according to the FDA website. As stated on the website, "This organizational approach replaces a management structure based on geographic regions." 

The Agency is reorganizing the ORA staff in order to help the FDA implement the Food Safety Modernization Act signed by President Barack Obama in 2011. The ORA will more closely mirror the Agency's organizational model and enhance the effectiveness of its communications and processes to keep pace with scientific innovation and protect public health, according to the website.

Prior to the reorganization, the 20 ORA district offices reported to five regional heads. After implementing the ORA's new program-based management model, there are seven key programs for operations:

  • Pharmaceutical quality
  • Medical devices
  • Tobacco
  • Animal and human food
  • Biologic drugs, which are made from living organisms and include vaccines
  • Research, including protecting research subjects and ensuring data quality
  • Enforcement and import operations.

Except for the tobacco product office, each product-specific office is, in turn, organized in two or more regional divisions, which will be served by the agency's 20 existing districts and 13 field laboratories. According to the FDA, the field laboratories also will be aligned by product area, focusing on food, medical products and tobacco, or both. 

In departing from the ORA's historic geography-based model, the ORA staff will now specialize in the specific substantive areas and will no longer do work in more than one program area. The FDA envisions that these changes will result in a high level of technical expertise and more uniform application of the ORA's policies and processes.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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