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TMAP: Planning for Efficient, Effective Data Management at FDA

February 21, 2020

On an Alliance-sponsored webinar this week, FDA’s Principal Deputy Commissioner and Acting Chief Information officer, Dr. Amy Abernethy, spoke about the Technology Modernization Action Plan (TMAP) released by FDA and the next steps at the agency. She stressed that the goal of all FDA’s technology modernization efforts is to use data more efficiently and effectively to improve food and drug safety.

Dr. Abernethy explained that her focus is on enterprise (cross-agency) approaches, but that success is dependent on the resulting systems being usable by centers in carrying out their own missions. This is reflected in the three TMAP elements: (1) modernization of FDA’s technical infrastructure; (2) enhancing FDA’s capabilities to develop technology products to support its regulatory mission; and (3) communication and collaboration with stakeholders to drive technological progress that is interoperable across the system and delivers value to consumers and patients.

TMAP anticipates shoring up enterprise IT systems and implementing cloud computing technology that will better support FDA’s strategic mission. When asked about the need for additional funding to do this, she expressed a preference for FDA to understand its specific needs better and then adjust the budget once that has occurred.

Dr. Abernethy stressed that examples are often essential to understanding what is possible and to learn how to scale and adapt specific uses into new applications. She pointed to IND safety data required to be reported in 7 and 15 days. These reports come into the agency in several ways, but none that readily permits data analysis through secure channels. FDA is in the midst of converting to an interface so that company safety reports can be transmitted securely into FDA systems. This would allow better informed analysis and illustrates the critical importance of interconnectivity between platforms.

She sees multiple possibilities for FDA to create new solutions, with this particular use case as a beginning point. She mentioned globalization issues as one direction this could take. Coordination across the globe will allow for increased workforce security and support traceability/supply chain management.

Asked about models for FDA’s efforts, she said TMAP was inspired by DOD’s technology modernization that, among its many strengths, put a priority on cybersecurity. She noted that FDA’s solutions are intended to provide seamless and robust data protection and privacy.

Dr. Abernethy’s own technology background inspired her to bring employees together in temporary ways to solve problems and then be disbanded. She would like to create a culture of innovation focused on “failing fast” and finding alternative ways to solve problems. She thinks it is possible to do this within government if the metrics of success and failure are clearly identified.

In response to a question about interoperability, Dr. Abernethy pointed to the several challenges involved, both systemic and semantic. The push towards interoperability is a progressive set of tasks, in which data will communicate with each other. Interoperability cannot be mandated from the top — it will take decades to achieve. Rather, it must flow from the bottom to the top.

In response to a question about her experience at FDA, Dr. Abernethy talked about how remarkable FDA employees are and that government moves far quicker than most people realize. She urged those who are interested to submit comments to the open docket associated with the FDA’s March 27 hearing. For more details on attending (in-person or via the web) and for information on submitting comments, please go here.

Editorial note: The Analysis and Commentary section is written by Steven Grossman, Deputy Executive Director of the Alliance for a Stronger FDA. Special thanks to Reed Diskey for sharing his meeting notes.

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