DMAP: Focusing on a Fundamental Challenge

The FDA’s new Data Modernization Action Plan (DMAP) (here) is the focal point for one of FDA’s greatest challenges: its myriad databases don’t communicate with each other, even within the same Center. Countless inefficiencies result. Further, the lack of data integration deprives FDA of opportunities to use so-called big data (sets) that can provide information and insights that cannot be gleaned from separate data sources.Reflecting the importance of the DMAP initiative, Acting Commissioner Dr. Janet Woodcock and Principal Deputy Commissioner and Acting Chief Information Officer Dr. Amy Abernethy -- the two highest ranking agency officials -- penned an FDA Voice column (here) to discuss the details of the Action Plan and explain why it is so important to the agency. The context:

data have always formed the basis of the FDA’s science-based regulatory decision-making. These data may come from relatively traditional sources -- for example, measurements submitted to the FDA from clinical trials or observations from FDA field inspections. As technology has become more sophisticated and our world has become more connected, data from many new sources are helping us understand how medical products are performing, how we can pinpoint the source of a foodborne illness, for example, or understand an emerging public health threat.

Trade press (RAPS Regulatory Focus, STAT, and others) drew further attention to the DMAP plan.Selling the Opportunities. Because data modernization builds capacity rather than directly addresses problems, it can be a tough sell. To counter this, Drs. Woodcock and Abernethy point to a sample of three tangible results that could come from data modernization:

• Tracking and tracing medical and food products across the entire supply chain
• Integrating real-world and clinical trial evidence to increase representation of diverse populations, creating efficiencies and completeness in product reviews and post-market surveillance
• Enabling privacy protections that can advance the evaluation of potential treatments for rare diseases, while protecting patient-specific information

DMAP envisions data modernization resulting in improved search capabilities that would reduce the burden of manual, inefficient processes on FDA staff.Three Parts to the DMAP Plan. The action plan delineates three sets of initiatives:

• Identify and execute high value driver projects for individual centers and the Agency. Driver projects for DMAP (really pilot projects) will not only address traditional performance indicators, but will also support transformation across the agency by using predictive models, and appropriate application of trends, such as Artificial Intelligence (AI).
• Develop consistent and repeatable data practices across FDA. A modern data strategy also requires proactive investments in foundational capabilities. Key components of data practices to achieve these goals are Identification; Data Curation; Governance; and Automation.
• Sustain a strong talent network combining internal strengths with key external partnerships. It’s critical that the agency have a strong focus on talent and elastic talent networks, to ensure that the modernization plan will be swift, consistent, and economical.

The DMAP is not simple or easy to grasp. Nonetheless, DMAP provides a pathway to “the 21st Century regulatory agency” that will maximize FDA’s value to the American people.Editorial Note: The Analysis and Commentary section is written by Steven Grossman, Executive Director of the Alliance for a Stronger FDA.