Last September, we were the first to report on trends relating to changes in leadership at the FDA’s Office of Regulatory Affairs. At the time, it was unclear if the shuffling of staff would be followed by larger changes in the Office of Regulatory Affairs’ operations. This now appears to be the case.
As reported by Regulatory Focus, FDA Commissioner Margaret Hamburg has unveiled major and sweeping changes to the agency that will see the regulator’s many divisions reorganize in an attempt to become more specialized and able to address increasing scientific and regulatory complexity.
Seth A. Mailhot and Leah Hurtgen Ziemba, attorneys at Michael Best & Friedrich LLP, outline eight significant changes to the Office of Regulatory Affairs in a recent article. They write (quoted, in part):
1. Commodity-Based and Vertically-Integrated Regulatory Programs
“The change directed by Commissioner Hamburg will move FDA towards organizing its regulatory and compliance activities by commodity-type, with the following identified programs:
- Pharmaceutical quality includes drugs and biologics regulated by Center for Drug Evaluation and Research (CDER) and veterinary drugs
- Food and feeds
- Medical devices and radiological health
- Products regulated by Center for Biologics Evaluation and Research (CBER)
- Tobacco
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Bioresearch Monitoring (BIMO)
This will likely increase oversight that each Center has over inspection and compliance personnel. These employees are mostly part of the Office of Regulatory Affairs (ORA), which directly manages the district operations. This is viewed by FDA as allowing it to “speak” with one voice on policies and operations related to any given commodity.”
2. Specialization
“Employees in inspection and compliance roles will specialize in particular commodities. This will include compliance officers, who traditionally are more likely to be generalists. FDA also raises the possibility that some in the medical device commodity may even subspecialize due to the diversity in the industry.
Employees will be centrally managed in ORA commodity-specific offices that coordinate closely with the Center that oversees the specific commodity. The only exception to the Center oversight will be in the Bioresearch Monitoring (BIMO) program, which will be a shared responsibility of the relevant Centers, ORA and the Agency Office of Good Clinical Practice.”
3. Training
“In order to further the specialization of its inspectorate and compliance staff, FDA will revise its training program to develop a commodity-based set of competency requirements, training curricula, certification/qualification/accreditation processes, performance assessments, and a continuing education program. The training program should further the goal of providing regulated industry with a uniform, consistent application of regulatory standards.”
4. Agency Work Planning
“FDA plans to build a new program-based work planning system based on risk factors, public health outcomes, past inspectional history, and operational experience. The work planning system will incorporate a multi-year outlook on future priorities and activities in order to appropriately manage resources to meet future program needs.”
5. Compliance Policy and Enforcement Strategy
“FDA also plans to revise its compliance policies and enforcement strategies to limit the multiple layers of case review, inadequate coordination, and lack of prioritization, and will designate firm lead roles in each commodity area to diminish the fragmentation of authority currently experienced by the Agency. FDA will also be developing what it calls “performance-based metrics” for compliance casework and other actions.”
6. Imports
“FDA will also apply a commodity-based approach to its import operations. This does not appear to be as sweeping as the proposed changes to domestic operations, but will include establishing import strategies by commodity, and focusing import operations consistent with Center designated, risk-based compliance strategies and policies.”
7. Laboratory Optimization
“FDA laboratories will also become more specialized and management will become more centralized. Laboratories under ORA, which are currently managed under the same geographic scheme as investigations and compliance operations, will ultimately report centrally to a senior executive level scientist leading the Office of Regulatory Science within ORA.”
8. De-layering
“FDA also intends to de-layer the management and review levels involved with enforcement actions. This would be implemented through the formation of specialized units in ORA operating program-based staffs directed and managed by commodity-specific offices and led by a senior executive.”
Conclusion
The attorneys summarize:
“Although these changes will not have an immediate direct impact on regulated industry, they will result in significant changes to FDA’s inspections and compliance operations, potentially starting as early as the next fiscal year. Over time, this will result in a marked change to inspections and enforcement actions. As more details on these changes emerge, regulated industry may want to consider reviewing their procedures and policies related to FDA inspections.” (Emphasis added).