FDA sets new date to talk future data strategy

UPDATE: April 28, 2020: FDA said Tuesday it's rescheduling a public meeting on modernizing its data strategy for June 30 on FDA's campus. The meeting was originally slated to take place March 27. The related public comment period is also being extended to July 30.

Dive Brief:

FDA plans to host a public meeting regarding how to modernize its data strategy, the agency said Tuesday.
At the event scheduled at its White Oak campus March 27, FDA and stakeholders will discuss how the agency ought to approach data quality, stewardship, exchange and analytics in the coming years.
FDA thinks the discussion is needed given projections that the scale and complexity of data it handles will increase quickly.

Dive Insight:

FDA last year laid out how its plans to improve its computing and technology infrastructure. In the document, called the Technology Modernization Action Plan, FDA detailed the steps it will take to put computing systems in place to get new products to patients. The meeting builds on that plan.

"The next step is to combine our computing capability with state-of-the-art approaches in data management, analysis and decision-making. We will work with internal and external experts on how to best approach important topics like data stewardship, strategy, standards and more," FDA principal deputy commissioner Amy Abernethy said in a statement.

FDA is splitting the broad topic up into three areas to inform the discussion. One is focused on data standards and policy. Specifically, FDA wants to discuss the use of common data standards, the consequences of moving from static to continually updating datasets and how to avoid duplication while sharing data assets.

The other two topics cover data privacy and sharing. FDA wants to gather views on how it can protect data privacy and security while ensuring its staff and external partners can access resources they need.

FDA is still sourcing presenters and panelists for the event and is accepting applications from those who want to speak until Jan. 28. Individuals who want to attend the meeting have until March 24 to register. In parallel, FDA is sourcing written submissions from people and organizations that want to express their views on the agency’s approach to data.

The meeting comes early in Stephen Hahn’s time as FDA commissioner. Hahn was sworn in as FDA commissioner late last year and commented on the data meeting this week, stating the agency is committed to having "mechanisms for collecting, reviewing and analyzing data [that] are equally as sophisticated as the scientific advances that we are reviewing."