It has been a little over a year since the FDA issued a memo outlining the reorganization they would undertake to change inspection activities. This plan is expected to better align resources in order to achieve their objectives. At its core, the change will move the agency from a regionally based system to a product focused method. Each region currently has a mixture of investigators that are generalists with those that are product specific. To first develop the expertise necessary, product types will be identified within certain programs.
Pharmaceutical quality (CDER)
Food
Medical Devices
CBER
Tobacco
Bioresearch monitoring
Specialized Investigators
The inspectors will be trained to cover a specific product and will be governed by the Office of Regulatory Affairs (ORA). This group will work closely with each program to align their plans and strengthen the communications between field activities and each department. The hope is to develop expertise within product areas and better utilize resources. Throughout the year they will continue to develop a program to enhance the competencies of its current inspectors with a goal of having the changes in place within 2 years.
New Office, New Teams
The inspection changes are part of a larger reorganization which created the Office of Pharmaceutical Quality (OPQ). The OPQ is tasked with integrating inspections and enforcement policies in one department. The creation of specialized teams will provide a more streamlined approach to review and feedback utilizing these individuals who will be familiar with the product and have a specific level of expertise. These team based reviews will become policy under the OPQ.
Other Changes
These product specific enforcement units will be implemented under an initiative called the Program Alignment Group or PAG. Included in the plans are to change from a 2 year cycle of inspections to a more risk based approach. An inspection will be warranted after an assessment of the overall state of quality. Those with the poorest scores will be visited more frequently. This assessment will be initiated after the development of quality metrics which will set standards based on industry performance.
The Long Term
The completion of this reorganization and any benefits will be realized incrementally. Revisions in the internal training program will take time to gain traction. Once the pool of specialized inspectors has been developed, changes in the inspection planning process will hopefully become more efficient. Ideally, fewer inspections will lead to more focus on proactive quality improvement programs and resources to follow-up on severe violations where they occur. As with any change, growing pains will most likely happen.
Time will tell if this reorganization produces the desired outcomes.