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.
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