FDA, MIT to collaborate on drug safety
Here’s a story from the AP describing in very little detail a collaboration between FDA and MIT to monitor provider databases for adverse event signals. I know nothing about how the collaboration came about or which group at MIT will be leading the data mining efforts. When I find out, I’ll post a blurb. In any case, this is an important step in the development of an active safety surveillance system monitored by FDA. Industry should applaud and support this and related efforts, as faster, more accurate safety signals and estimates of incidence will hasten detection (and response) to adverse events and help to distinguish drug-related adverse reactions from unrelated adverse events. In short, this is ostensibly an important publicly funded risk management tool that will augment industry’s own active-surveillance risk management tools. Ultimately, these tools should markedly reduce the safety liability associated with new-drug launches.
