When it comes to enforcement actions against regulated industry, FDA has a “blank check” and keeps no records related to resource expenditures, either monetary or employee time. This is the conclusion to be drawn from three recent and uniform agency responses to Freedom of Information Act (FOIA) requests for documentation on resources expended in two controversial enforcement actions. They are the 2005 federal court QSR/GMP loss to Utah Medical Products (Midvale, UT), and its four-year-old ongoing MDR case against TMJI (see previous story). The first response, reported here last month, came from Office of Chief Counsel deputy chief counsel for program review Ann Wion. She said her office had “no responsive record” to my request for “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] ...” Subsequent inquiries revealed that, as in all other government agencies, such attorney work product records have been shielded forever from public access since a 1983 Supreme Court ruling. Nevertheless, I still await a Department of Justice response to my request for a cost accounting of its expenses in these cases. Meanwhile, trying another tack, I broadened and revised my request at FDA to exclude attorney work product. It now encompasses “estimates of inspection time, investigation time, compliance officer time, center review time, and Office of Chief Counsel review time, expressed in both dollar and FTE terms, for FDA work performed in preparing compliance and enforcement action, exclusive of actual litigation expense, against” Utah Medical and TMJI. In due course, I again received a neg-ative response from Wion, advising “we have no responsive records from the Office of Chief Counsel.” I also received one from CDRH Freedom of Information Branch officer Joy Lazaroff, saying that “we did not find the requested records.” She added that such information “is not maintained” by CDRH and that this was a partial response; other unnamed FDA components would separately respond. Presumably one of those was Wion’s office. Another component might be FDA’s Denver district office, where the inspections of both Utah Medical and TMJI were based. Colleague John Scharmann, a former Denver district director himself, advised me that field investigators do make out time sheets regarding their inspections, and report travel and other inspection-related expenses that might be accessible under FOIA. I immediately submitted a request for those documents. Scharmann doesn’t believe similar records are kept for employees in other parts of FDA. This impression is reinforced by a former FDA headquarters official who added that he believes FDA should adopt a cost-accounting approach for employee time, so that answers can be given for such questions as, “What is the cost of each action that FDA takes? For example, what is the cost of a warning letter or seizure or litigation from start to finish? I don’t think FDA exercises that kind of accountability at the present time. The question is, why not? How are they accounting for resources—especially when they continually say that the agency does not have enough resources?” -- James G. Dickinson