In late 2013, the U.S. Food and Drug Administration (FDA) announced it was embarking upon a program to realign its structure and programs to keep up with the challenges posed by advances in science, globalization, and product complexity.  By February 2014, FDA Commissioner Margaret Hamburg, M.D., had unveiled the sweeping changes to the agency that will see its many divisions reorganize to become more specialized.

An internal Program Alignment Group (PAG) was tasked with charting a course for modifying agency functions and processes to improve communications, collaboration, and to clarify roles, responsibilities, and decision rights across all agencies.
 

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New emphasis for regulatory and compliance programs

The PAG strongly recommended that regulatory and compliance activities be organized around distinct commodity-based and vertically-integrated regulatory programs, including:

• Pharmaceutical quality — for drugs and biologics regulated by the Center for Drug Evaluation and Research (CDER) and veterinary drugs
• Food and feeds
• Medical devices and radiological health
• Products regulated by the Center for Biologics Evaluation and Research (CBER)
• Tobacco
• Bioresearch Monitoring (BIMO)

These programs will have governance and budgets to ensure that resources are allocated to strategic priorities, and that the FDA speaks with one voice on policies and operations related to any given commodity. Specific to CDER, the division has published a timeline and plan for addressing the realignment activities¹. Although the plan is only a framework, it does provide a glimpse of the FDA of the future.  

Most notable is the emergence of the Office of Regulatory Affairs (ORA) as a focal point for the transformation to a commodity-based structure. The ORA is the lead office for all agency field activities. ORA inspects regulated products and manufacturers, conducts sample analyses of regulated products, and reviews imported products offered for entry into the United States. The intent behind this new strategy is to drive greater alignment between ORA and the Centers. This has been a perennial issue for decades although consistency between the district office and the Centers has been steadily improving. The PAG also advocates the establishment of more specialized resources with ORA taking responsibility for creating an educational and training architecture.

Dr. Hamburg has described her vision to establish a cadre of compliance officers as specialized investigators across the FDA who have similar levels of technical expertise, able to work more closely with Center experts on complex scientific, manufacturing, or other regulatory challenges.

The transformation to a commodity-based vertical will mean reapportioning internal resources and redefining oversight and management. This is never a quick and easy undertaking in a government agency. It will be interesting to see how the agency manages surveillance as these new programs are developed and move toward implementation. It is likely the industry will see greater enforcement variability from regional offices. The expected timeframe for the planning process is Q3 2015, with implementation to begin by the end of the fiscal year 2015.

The final major takeaway from the program alignment plan is the commitment to outcome-based metrics. The PAG recommended that each Center be charged with constructing a new program-based work planning regime to base compliance activities on risk factors, public health outcomes, past inspectional history, and operational experience. Those activities are to be tracked with performance-based metrics clearly demonstrating public health and compliance outcomes. Metrics have been part of the FDA’s toolkit internally for some time, starting with the FDA-TRACK program that measures departmental performance against strategic initiatives. This new vision extends this philosophy, particularly to imports where the agency has implemented its PREDICT² (Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting) electronic screening tool for import operations.  The new plan calls for the Center to share its PREDICT evaluation data and adjust its risk scores appropriately to align itself with this new strategy.

The PAG’s recommendations map into six core areas, as follows:

1. Specialization across FDA’s inspection and compliance functions, to enable the agency to mirror, adapt to, and track the continuing program-based specialization within the FDA’s regulated industries and according to the demands of new legislation. 
2. Training to be developed collaboratively by ORA and the Centers, leading to the development of competency requirements, training curricula, certification/qualification/accreditation processes, performance assessments, and a continuing education program that enables the FDA to enhance and maintain the quality of its workforce.   
3. New work planning that improves the FDA’s selection of firms, inspection frequency, and compliance efforts based on risk factors, public health outcomes, past inspectional history, and operational experience. This is reported through performance-based metrics that clearly demonstrate public health and compliance outcomes.  
4. Compliance policy and enforcement strategies are to be clear, current, outcome-based, and effectively communicated to maximize the FDA’s ability to protect public health and to exercise effective, efficient industry oversight.  
5. Laboratory optimization that increases specialization, fosters program alignment and collaboration between the Directorates, ORA, and the Centers, and enhances efficiency within the current laboratory configuration.  
6. Alignment of Center and ORA practices, processes, and resources to support ORA’s implementation of the FDA’s commodity-based and prevention-focused regulatory programs.  
    

The next few years will be telling as the FDA moves to implement this modern vision of a commodity-based organization. How effectively roles and responsibilities are reassigned and communications reestablished depend on how turbulent the next five years will be for the industry. It falls upon the Centers and ORA to shore up their capabilities to meet the technical and scientific challenges of the new global market.

References

1. http://www.fda.gov/downloads/AboutFDA/CentersOffices/UCM416952.pdf
2. http://www.fda.gov/downloads/ForIndustry/ImportProgram/UCM316476.pdf 

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Bikash Chatterjee, President and Chief Science Officer of Pharmatech Associates, has been involved in the biopharmaceutical, pharmaceutical, medical device, and diagnostics industry for over 30 years. His expertise includes site selection, project management, design, and validation of facilities for U.S. and European regulatory requirements.

This article appeared in the March 2015 issue of Controlled Environments.