FAERS - AERS, but Fancier

Someone at FDA sent this to me recently (see below). It's an email sent around from within the FDA announcing a new Adverse Event Reporting system (sort of).

Emphases are mine. Editorial comments are mine, too.

Spoiler alert: They forked over $$$$$ and went with Oracle.

Bioinformatics Board (BiB) News

Post Market Safety BRB Announces Selection of Vendor[We've decided to shop at Barney's. Can't tell you what we're buying just yet, but it's gonna be FAB!] for New Enterprise Adverse Event System

The Bioinformatics Board (BIB) News provides FDA employees with an update on the activities and progress of the BiB. This month’s news focuses on the Post Market Safety BRB and the selection of the Adverse Event System Vendor. For more information about the BiB or the contents of this message, please contact your BiB representative or email the Bioinformatics Board, bioinformatics@fda.hhs.gov.

Post Market Safety Business Review Board Announces Selection of Vendor for New Enterprise Adverse Event System FDA’s Bioinformatics Board and the Post Market Safety Business Review Board are pleased to announce a significant milestone for the Agency. After an extensive analysis of FDA scientific needs for the management and analysis of post market product safety reports, and an evaluation of leading industry tools, the FDA Adverse Event Reporting System (FAERS) Program has selected Oracle AERS[$$$] (Adverse Event Reporting System) as the new tool for FDA staff[guess who's not getting access to the data juuuust yet...?] to efficiently[you wouldn't believe what we were doing before] analyze post market safety reports in order to identify potential product safety problems.

Selection of the new FAERS tool represents a significant landmark for the Agency. With the selection of an advanced tool that all centers and offices can leverage, the Agency can now focus on implementing processes for sharing post market safety data across our product centers as well as advancing the science of post market report analysis. Achievement of this milestone represents the efforts of numerous individuals from across the Agency over several years[wow. just...wow]. While in many ways this is just a beginning, it is important to recognize our progress towards meeting the goal of providing modern tools necessary to address many post-market surveillance needs. Selection of Oracle AERS[What? no love for MySQL? They're about to be subsumed by Oracle, too, ya know.] positions the Agency for success in this complex and dynamic arena.

We expect the initial users in CDER and CBER to receive training and begin using the new system as early as fall 2009[but don't quote us on that] with additional users being trained and brought on over time. CDRH users are expected to begin using the tool in 2010, and additional centers and offices expected shortly thereafter.