FDA unveils data modernization plan
A three-pronged plan to modernize the US Food and Drug Administration’s (FDA) approach to data was unveiled Wednesday, building on the agency’s previous technology modernization effort.In a blog post announcing the new Data Modernization Action Plan (DMAP), Acting FDA Commissioner Janet Woodcock and Principal Deputy Commissioner Amy Abernethy write that data modernization is the “next step” for the agency after its 2019 Technology Modernization Action Plan (TMAP). (RELATED: FDA lays out tech modernization action plan, Regulatory Focus 18 September 2019).
While the TMAP provided the foundation for FDA’s technology modernization and laid the groundwork for the agency’s strategy for data and data management, the DMAP provides a strategy focusing on “the stewardship, security, quality control, analysis, and real-time use of data to accelerate the path to better therapeutic and diagnostic options for people and animals, better secure the food supply chain, and provide state-of-the-art tools to enhance and promote public health.”
“Data have always formed the basis of science-based regulatory decision-making. These data may come from traditional sources—for example, measurements submitted to FDA from clinical trials or observations from FDA field inspections. As technology becomes more sophisticated and our world becomes more connected, data from many new sources can help us understand how medical products are performing, pinpointing the source of foodborne illness, or understand emerging public health threats,” FDA writes in the plan.
Despite the shift to digital technologies, FDA says its data systems “are still largely geared to a non-digital, document-based information paradigm.” Electronic documents, such as PDFs, FDA writes, “are not the same as digital data.” (RELATED: FDA: Digital safety data submission to supplant PDFs, Regulatory Focus 1 July 2020).
“Although FDA’s legacy technology and data systems allow the agency to meet its regulatory responsibilities, FDA urgently needs new, robust, and flexible capabilities to avoid losing future opportunities,” FDA writes.
Data Modernization Action Plan (DMAP)
FDA says that DMAP will be based around three key components: driver projects, consistent and repeatable data practices and fostering a talent network within the agency and with external partners.
“The DMAP is anchored on driver projects that contribute to the FDA’s public health responsibilities in the near term while also building critical capabilities for the future,” Woodcock and Abernethy write. Those projects would focus on identifying solutions and developing capabilities rather than focusing on the collection of data.
“This strategy avoids the pitfalls of focusing on data collection first and only then looking for questions the data can answer,” Woodcock and Abernethy write.
Another tenet of the plan is to promote consistent and repeatable data practices across the agency through identification, data curation, governance and automation.
“A modern data strategy also requires proactive investments in foundational capabilities. For example, reducing time to perform repeatable tasks such as identifying the right data for a given problem … will greatly reduce cycle time and better leverage precious analysis resources,” FDA explains. The agency’s goals for data practices include simplifying data acquisition and reducing cycle time; enabling better data quality and governance; accelerating model development and use; and providing security and scalability for enterprise use of data.
Lastly, FDA says its data modernization plans require a talent strategy that needs to consider compensation, in-demand data science skills and cross-training of experts to increase talent capacity.
In the near-term FDA says it will begin work on the plan by forming an agency-wide DMAP steering committee, planning resource needs and conducting discovery sessions to identify best practices for the initiative. FDA also says it will identify specific driver projects to move forward with, gather feedback on the plan and launch programs corresponding with the actions outlined in the plan.
FDA