An information technology office at the Food and Drug Administration has done a poor job in seeking competitive bids for and overseeing millions of dollars of computer systems and software purchases, a government watchdog agency has concluded.
At the request of the Senate Finance Committee, HHS inspector generals office looked into the management and oversight practices of the Office of Information Technology at the FDAs Center for Drug Evaluation and Research and issued a 29-page report. The center oversees the safety and efficacy of prescription drugs from development through post-market reporting.
The Senate panel was alerted to problems with IT contracting at the federal agency after the Breckenridge Institute issued a draft report in 2006 that found the IT office mismanaged a project to develop a computer system for an FDA program that monitors adverse-drug events. The contracting snafus resulted in cost overruns and a loss of productivity, according to the Breckenridge Institute report, which also questioned the contractor selection and management processes at the IT office, the inspector general said.
In its follow-up investigation, the inspector general looked at 28 healthcare IT contracts for the drug education and research center from fiscal 2004 through fiscal 2007, each valued at more than $250,000. The total dollar amount of all contracts reviewed was not disclosed. The Office of Information Technology at the center does not have authority to enter into or terminate an IT contractthat duty belongs to the FDAs Office of Acquisition and Grant Servicesbut the IT office does provide technical expertise to the acquisition office and is supposed to monitor the contractor for compliance with federal purchasing regulations and to ensure the FDA is getting value for its money.
The inspector generals report said the IT office used such broad language in its contracts statements of work that it failed to specify contract requirements, suggesting that it had not thoroughly planned its IT services. In one example cited by the inspector general, the actual tasks that the contractor performed were specifically defined only after the (contract) award.
In another criticism, the inspector general said some technology orders used identical contract language to describe requirements in the statements of work even when the orders were for different services.
Also, for 27 of the 28 contracts reviewed, the Center for Drug Evaluation and Research relied on, essentially, no-bid, federal supply schedule, or FSS, contracts. The inspector general said the FDA unit is not alone in this regard, that its reliance on FSS contracts reflects a larger trend across government in which the use of FSS had grown to $35.1 billion" in fiscal 2006. The IT office orders using the supply schedule contracting vehicle included the purchase of personnel services for operations and maintenance work, tasks that were previously performed by the FDAs own staff workers, the report said.