How much did FDA spend in litigating its cases against Utah Medical Products (Midvale, UT), which it lost in 2005, and TMJ Implants (Golden, CO), which is currently under appeal? Judging by FDA responses to two Freedom of Information Act requests I filed seeking revelatory documents, the agency does not know. “This is to advise you that we have no responsive records from the Office of Chief Counsel,” wrote deputy chief counsel for program review Ann Wion in identical responses dated June 26. In each case, my requests sought “legal expense summary documents showing accumulative dollar amounts and full-time equivalent (FTE) employee resources expended in all regulatory enforcement activities and [civil money penalties] litigation against [company]...” FDA’s response suggests that when it comes to initiating litigation, cost is not a consideration, a comment that provoked some lively reactions on my Web site, www.fdaweb.com. One FDA employee indignantly said cost should never be a concern—public health and safety should be the only concern when FDA considers litigation. This, however, overlooks the fact that in the two cases for which I sought cost information, FDA did not allege that there were any public health and safety problems. Moreover, the question begs the issue of public accountability, of which keeping track of costs is surely a part. Others suggested that since it is the Department of Justice that brings FDA cases to court, my cost inquiries should be directed there, instead. So that is what I have done, as well as filing with CDRH for its investigational (as opposed to litigation) costs in bringing these two cases forward. I’ll keep you posted. -- James G. Dickinson