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Data Modernization: BIO Comments on Modernizing the Food and Drug Administration’s Data Strategy

July 30, 2020

July 30, 2020

Re: Docket No. FDA–2019-D-5799: FDA’s Public Meeting, Modernizing the Food and Drug Administration’s Data Strategy.

Dear Sir/Madam:

The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments regarding FDA’s Public Meeting, Modernizing the Food and Drug Administration’s Data Strategy.

BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO’s members develop medical products and technologies to treat patients afflicted with serious diseases, to delay the onset of these diseases, or to prevent them in the first place.

When discussing “data” throughout this letter, BIO takes a broad definition as laid out in FDA’s Technology Modernization Action Plan (TMAP), “…the data that is collected during the routine care of patients, coupled with traditional clinical trial evidence, will be used to generate steady improvements in future patient care. Other data types, such as genomic or toxicology data, and output from medical devices, are a part of the data ecosystem. Data-informed technologies, such as distributed ledger solutions like blockchain, will be critical to support FDA’s track-and-trace priorities.”

We support FDA’s efforts to modernize its data strategy to ultimately transform the way data is shared, analyzed, and utilized for regulatory purposes. It will be important to keep in mind, however, as FDA considers these advancements that just as it will take FDA time to implement appropriate IT infrastructure and capabilities to enable these modernizations, industry will need time to implement compatible technologies and processes as well. FDA’s engagement with stakeholders, including industry, in these cases is critical and should, most importantly, allow for flexibility, optional adoption by industry, and/or a phased approach with ample time for implementation as appropriate.  

BIO requests the following key features be considered as FDA continues discussions regarding its modernization efforts:

  • transparency on FDA’s data strategy and inclusion of Sponsors in discussions
  • expertise to support FDA’s data strategy
  • cross-Center, cross-government alignment and interoperability
  • international harmonization and interoperability 
  • collection of data through clinical trials

BIO appreciates this opportunity to submit comments regarding FDA’s Public Meeting, Modernizing the Food and Drug Administration’s Data Strategy. In addition, BIO would like to understand how FDA’s TMAP, cloud-based submissions, and plans to adopt IDMP will address the requested key features for FDA’s Data Strategy listed above. We appreciate that at the end of the Public Meeting, Dr. Abernethy noted that this Public Meeting is just the beginning and that FDA will be holding additional large and small meetings on various related topics. We remain committed to engaging with the Agency on these important topics. We would be pleased to provide further input or clarification of our comments, as needed.

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BIO Comments on Modernizing the FDA's Data Strategy
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