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FDA compliance IT setup needs “considerable work”, GAO says

By Nick Taylor , 18-Apr-2012
Last updated on 18-Apr-2012 at 09:34 GMT

The US FDA IT system for improving oversight of regulatory compliance needs “considerable work”, a GAO report found.

Work on the project began in 2002 but the US Food and Drug Administration (FDA) has faced a series of delays. The result is the old system, criticised by the US Government Accountability Office (GAO) in 2008 for failing to track overseas production plants, will stay in place at the FDA until at least 2014.

Despite its importance to FDA’s overall modernisation efforts, much of the planned functionality has not been delivered, and FDA has yet to retire the legacy systems MARCS (Mission Accomplishments and Regulatory Compliance Services) was intended to replace”, the GAO wrote in a look at the FDA .

When the FDA began developing MARCS in 2002 it predicted development would cost $75m (€57m) and be complete in 2008. After a series of delays through the 2000s the FDA re-estimated the cost of development in 2011 at $178m, with steady state expenditure adding another $105m to outgoings.

While struggling to develop MARCS the FDA has used OASIS (Operational and Administrative System for Import Support). In 2008 and 2010 the GAO found OASIS “provided an inaccurate count of foreign establishments manufacturing drugs offered for import into the US”.

Retirement of OASIS is now planned for July 2014 but the GAO warns the FDA there is “considerable work to accomplish on MARCS”, its successor. As of February, the FDA was yet to start work on 12 of the 30 components of MARCS.

Certainty around costs and timelines for these components is, the GAO says, lessened by the project management method used by the Agency. “The FDA and the contractor are using separate schedules to manage the work and are coordinating their schedules at biweekly meetings”, the GAO wrote.

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