How FDA’s Program Alignment Initiative Will Impact Industries: An Insider’s Perspective
In his first major announcement since taking office, FDA Commissioner Scott Gottlieb, M.D. finalized a major reorganization plan that had been under development since 2013. The reorganization, termed “Program Alignment,” reassigns field staff based on product type rather than geographic regions. Under the new organizational model, inspection and compliance staff in FDA’s Office of Regulatory Affairs will specialize in the five commodities and two enforcement areas:
- Pharmaceutical Quality;
- Human and Animal Food;
- Medical Devices;
- Biological Products;
- Bioresearch Monitoring; and
- Enforcement and Imports.
This announcement is being viewed by some as a strategic public relations maneuver by Gottlieb meant to mitigate concerns that the FDA might devalue its safety and oversight responsibilities under his leadership. Also, the alignment will better position FDA to implement the agency’s new authorities under the Food Safety Modernization Act.
Program Alignment is intended to benefit both the agency and its regulated industries by allowing investigators and their managers to develop a high level of technical expertise in one commodity. Product-based field operations that are vertically integrated and aligned with FDA’s product centers should enhance the efficiency and effectiveness of intra-agency communications and lead to more predictable and consistent inspections for investigators and manufacturers alike.
Impact on FDA-Regulated Industries
Greater specialization will mean investigators have greater proficiency with the products and processes they inspect, which could lead to more in-depth, comprehensive inspections. To the extent that increasingly detailed inspections leads to more inspectional observations and enforcement actions, this may lead to the perception of increased safety concerns regarding FDA-regulated products. However, in reality, this new specialized system likely will result in the identification of issues that previously may not have been uncovered.
Program Alignment also presents an opportunity for industry to develop a better rapport with FDA personnel by virtue of meeting and working with the same group of inspectors over an extended period. Companies will be able to educate agency investigators on their policies and practices they have designed to ensure the safety of their product. This is an environment that currently exists between the meat and poultry industry and USDA’s Food Safety Inspection Service; the dynamic can lend itself to a collaborative approach that ultimately improves public health.
Impact on FDA
While Program Alignment fosters improved communications between FDA and regulated industries, it also provides benefits to the agency. In addition to improved inter-agency coordination, the new structure should allow for a more efficient and targeted training of investigators, allowing them to develop subject matter expertise.
Further, increasing the coordination between the agency’s six centers and ORA could allow for greater participation by field staff in developing agency policy. Aligning the field and headquarters will enhance FDA’s ability to analyze key data and consider practical implementation of the policies they develop; this will be particularly important as the agency’s continues to use targeted risk-based enforcement to maximize its limited resources.
The Food, Drug, Medical Device & Agriculture group will continue to closely monitor the implementation of FDA’s Program Alignment initiative. If you have any questions, please contact Brian Ronholm, who served as USDA Deputy Undersecretary for Food Safety from 2011–2017; Paul Gadiock, who recently served as Associate Center Director for Policy in FDA’s Center for Devices and Radiological Health; Emily Leongini, who also previously worked as a Regulatory Counsel at FDA in both CDER and ORA; Brian Malkin, a former FDA Regulatory Counsel in the Office of the Commissioner, Office of Health Affairs and CDER; or the Arent Fox professional who regularly handles your matters.