Back in 2019, as part of a program focused on improving documentation and communications for drug approvals, the FDA made a change to how it explains its decisions.
At the time, academics and industry criticized the shift because it could potentially reduce the quantity and quality of the documents the agency was releasing about its drug reviews.
“We are writing to express our concern with FDA’s proposal to replace individual original reviews with a new integrated review. There is a scientific publishing norm that authorship should be voluntary, and by institutionalizing group authorship, all authors of integrated reviews may not have a chance to voluntarily approve of the text in a document that bears their name,” Fiona Godlee, former editor-in-chief of the BMJ, and Clare Stone, former editor-in-chief of PLOS Medicine, wrote to the FDA in 2019.
On Thursday, the FDA sought additional comment on the integrated reviews documentation, which has already been implemented for new molecular entities, original biologic applications, and select efficacy supplements, and is coming soon for other products.
The agency is again seeking responses to questions like: “Comparing the integrated review to previous review documentation, is there any information you are having difficulty locating?”
The agency acknowledged that the new system is an abbreviated version of what it did before.
“This new integrated review document replaces the previous documentation, which included a separate review document authored by each discipline. It also replaces the multidisciplinary review (i.e., Unireview) in which each discipline provided a separate review section but within a single review document,” the FDA explained.
But the regulator believes the new format will still provide “sufficient detail” concerning efficacy and its assessment of risk and risk management “as well as a clearer description of FDA’s analysis of the scientific issues raised by the application and the scientific reasoning supporting the benefit-risk determination.”
By implementing the new streamlined structure for its documents, the FDA said the internal process is more coordinated, and it’s easier to reach a more diverse audience, including the public, drug sponsors, researchers and others seeking to understand the basis for FDA’s decisions.
The FDA released three examples of what the new format looks like, including three integrated review documents for Sanofi’s Nexviazyme, GSK’s Rukobia and Madrigal’s Rezdiffra.