FDA’s secret database

Ok, the title’s a little dramatic. I’ve been exploring the adverse event database (MAUDE) for glucose meters, which is a publicly available database. But some records were a summary of events. This shouldn’t be since individual events are supposed to be entered.

What happened was there was an alternative summary reporting (ASR) system in place, which was not available to the public.

This was exposed in March 2019 by some excellent reporting by Christina Jewett.

In June of 2019, the FDA described ASR and said it has ended with all data now in MAUDE (hence the summary data I found). They start out by saying “In the spirit of promoting public transparency...” Well to be transparent, don’t have secret databases in the first place! The problem is there was never any reasonable explanation for why this data was not available to the public. For example, one reason stated was “ASR reports were not made publicly available because they were not submitted in a format compatible with the public database.” Ok, so change the format!

The real basis for the ASR database is still a mystery.