How FDA’s Program Alignment Initiative Will Impact Industries: An Insider’s Perspective

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:

1. Pharmaceutical Quality;
2. Human and Animal Food;
3. Medical Devices;
4. Biological Products;
5. Tobacco;
6. Bioresearch Monitoring; and
7. 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 Life Science group will continue to closely monitor the implementation of FDA’s Program Alignment initiative.