FDA goes shopping for AE software
FDA is actively soliciting sellers of COTS (commercial off-the-shelf) adverse-event software to strut their stuff for FDA brass. But software firms had better act quickly; this is a limited-time offer and demand has been strong (Actually I have no idea what the demand for this solicitation has been like, but it sounded good). FDA has published a Market Research Reference Guide to aid presenters in their sales-pitch efforts. What interests me about the the guide, though, is that it offers a few insights into FDA’s desires for AE-data tools.
Overall, it looks like FDA is headed towards installation of a comprehensive AE data capture, translation, archiving, retrieval, analysis and reporting system. Whether its able to find such a system in a single COTS package (highly doubtful) or it cobbles one together from a combination of COTS and custom packages (very likely) might affect the timing and cost of implementation, but we can only hope that it won’t affect the program’s apparent goals and eventual implementation.
FDA has lagged behind regulators in some other countries in its ability to capture and analyze safety signals. In part this has been due to lack of FDA leadership with the vision, skills, drive and authority to make the U.S. second to none as far as drug safety is concerned. But FDA has also been hampered in its efforts by lack of funds to perform all of the types of safety surveillance work that could and should be done with the right technology and collaboration among data holders. Getting the technology right is necessary first step that I’m glad to see FDA taking.
Now that PDUFA 2007 negotiations have opened up the door for increased industry funding of FDA safety surveillance efforts, responsibility for upgrading FDA’s drug surveillance capabilities falls to a newly Democratic Congress to pony up its share of increased FDA funding for drug safety surveillance. With enough money in FDA’s coffers, there will be no excuses for the U.S. to lag any nation in drug safety.
