BIO Comments on Data Standards for Drug and Biological Product Submissions Containing Real-World Data
February 4, 2022
On Friday, February 4th, BIO submitted comments on the Food & Drug Administration’s (FDA) recent draft guidance regarding the data standards for product submissions containing Real-World Data (RWD). In the comments submitted, BIO thanked the Agency for the opportunity to provide input on this important topic. In addition to specific line edits, BIO provided several overarching recommendations for the Agency to consider prior to finalizing the guidance. For example, BIO recommended that the Agency consider highlighting the strengths and limitations of prospective and retrospective real-world data and providing language to delineate the challenges more clearly with each type of data source. In particular, acknowledgement of the challenges sponsors face when utilizing retrospective data would be helpful. Furthermore, BIO advised that the current guidance seeks to align modern data sets to data standards that were created for a different era in healthcare research. To address this issue, BIO suggested the Agency consider providing guidance for a more far-reaching approach to data standards and create a new data standard approach tailored for RWD, given the evolving and emerging nature of RWD assets that can be at the FDA's disposal to facilitate data use for 21st Century research problems.Also included in the comment submitted, BIO agreed that data standardization is a worthwhile goal for the use of RWD in the evaluation of product benefit/risk; however, rigid requirements to transform all data into a format that was designed for clinical trials may not be practical, scientifically appropriate, or feasible. An appropriate degree of flexibility along with guidance for when it is not feasible for data to be standardized would make the incorporation of RWD in product submissions more feasible. BIO also stated appreciation for the Agency’s mention of the challenges in mapping and transforming RWD into data that meet FDA-supported data standards. Nevertheless, incorporating elements in the final guidance like how to document the impact of data mapping and transformation on the source data, how to address challenges raised when multiple RWD sources are used/linked, and inclusion of best practices for handling RWD fields that have been auto-populated, would be even more beneficial. Lastly, BIO suggested a greater degree of harmonization across the contemporary guidance documents on RWE. This harmonization would ensure that the Sponsor is incorporating all of the necessary information into the submission package to evaluate benefit risk.
Download Full Comments Below
BIO COMMENT LETTER RWD Data Standards FDA 2021 D 0548
BIO submits comments on the MDH’s proposed regulations regarding Drugs of Substantial Public Interest: Draft Methodology for Public Comment as required in statute by the Prescription Drug Price Transparency Act.
The Biotechnology Innovation Organization appreciates the opportunity to comment on the Center for Medicare and Medicaid Services’ Information Collection Request on the Part C and Part D Medicare Prescription Payment Plan Model Documents.
On Friday, February 4th, BIO submitted comments on the Food & Drug Administration’s (FDA) recent draft guidance regarding the data standards for product submissions containing Real-World Data (RWD). In the comments submitted, BIO thanked the Agency for the opportunity to provide input on this important topic. In addition to specific line edits, BIO provided several overarching recommendations for the Agency to consider prior to finalizing the guidance. For example, BIO recommended that the Agency consider highlighting the strengths and limitations of prospective and retrospective real-world data and providing language to delineate the challenges more clearly with each type of data source. In particular, acknowledgement of the challenges sponsors face when utilizing retrospective data would be helpful. Furthermore, BIO advised that the current guidance seeks to align modern data sets to data standards that were created for a different era in healthcare research. To address this issue, BIO suggested the Agency consider providing guidance for a more far-reaching approach to data standards and create a new data standard approach tailored for RWD, given the evolving and emerging nature of RWD assets that can be at the FDA's disposal to facilitate data use for 21st Century research problems.Also included in the comment submitted, BIO agreed that data standardization is a worthwhile goal for the use of RWD in the evaluation of product benefit/risk; however, rigid requirements to transform all data into a format that was designed for clinical trials may not be practical, scientifically appropriate, or feasible. An appropriate degree of flexibility along with guidance for when it is not feasible for data to be standardized would make the incorporation of RWD in product submissions more feasible. BIO also stated appreciation for the Agency’s mention of the challenges in mapping and transforming RWD into data that meet FDA-supported data standards. Nevertheless, incorporating elements in the final guidance like how to document the impact of data mapping and transformation on the source data, how to address challenges raised when multiple RWD sources are used/linked, and inclusion of best practices for handling RWD fields that have been auto-populated, would be even more beneficial. Lastly, BIO suggested a greater degree of harmonization across the contemporary guidance documents on RWE. This harmonization would ensure that the Sponsor is incorporating all of the necessary information into the submission package to evaluate benefit risk.