Biopharma companies to FDA: Internationally harmonize plans to standardize safety data and analysis

by Zachary Brennan

Senior Editor, Endpoints

As the FDA pushes to more broadly standardize the way it collects safety data to better detect concerning signals with pharmaceuticals, biopharma companies are pushing back on why there isn’t a more international approach given the global nature of the industry.

The current lack of standardization around the analysis of premarket safety data and visualization in applications has led to the FDA acknowledging that there have been inconsistencies in adverse event definitions, categorizations, analyses, and presentations.

The FDA Center for Drug Evaluation and Research’s Office of New Drugs has put together two new documents to better facilitate the internal review of safety data, including “FDA Medical Queries” or FMQ, which provides a standardized approach to group preferred terms of adverse events using “Medical Dictionary for Regulatory Activities” (MedDRA) terminology. The second document, “Standard Safety Tables and Figures Integrated Guide,” provides standardized methods for visualization of clinical trial safety data into tables and figures.

Following a one-day public meeting in September focused on these two documents, and organized by FDA and the Duke-Margolis Center for Health Policy, drugmakers such as Amgen, Merck, Gilead, Eli Lilly, AbbVie, Daiichi Sankyo, Bayer and others are now calling for a more internationally harmonized approach to safety data and analysis as the FDA moves forward with its own overhaul.

While most of the comments, which had to be submitted by tthe end of last month, express a sense of hopefulness that the FDA’s work will make the process smoother and lead to improved safety, others

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