FDA Law Blog: How Many Foreign Inspections Would Be Enough?

FDA Law Blog: How Many Foreign Inspections Would Be Enough?

How Many Foreign Inspections Would Be Enough? Posted: 06 Mar 2015 01:23 AM PST By Ricardo Carvajal - That’s the question raised by a recently issued Government Accountability Office (GAO) report that takes FDA to task not just for lagging behind the foreign inspection targets established by FSMA, but also for not conducting “an analysis to determine whether the number of inspections in the FSMA mandate or the lower number of inspections it is conducting is sufficient to ensure comparable safety of imported and domestic food.”  It’s a curious fault to find, given that the foreign inspection targets in FSMA were understood to be an arbitrary, unfunded mandate from the moment the ink dried on the President’s signature of the bill into law.  The chart below (drawn from the GAO report) says it all: FSMA called for a doubling of foreign inspections every year, starting from a baseline of 600 in the first year following enactment.  FDA is already well behind those targets, having completed just 28% of the number of inspections mandated for 2014.  The reason?  In a word, money.  Meeting the 2014 target would have required FDA to divert to foreign inspections nearly all of the FSMA implementation funding it received for that year.  The divergence between what the law directs FDA to do and what the agency has funding to accomplish will only grow more pronounced in the next two years. For its part, FDA sees value in maintaining foreign offices and conducting foreign inspections.  However, it’s clear from FDA’s comments on the GAO report that the agency knows where its real leverage lies – with full implementation of the Foreign Supplier Verification Program (FSVP), Voluntary Qualified Importer Program (VQIP), and third-party audit provisions of FSMA.  Properly implemented, those provisions could act as a force multiplier that would dwarf even the lofty targets built into FSMA.  Small wonder that the agency offers a tepid acceptance of GAO’s inscrutable recommendation: FDA concurs with this recommendation, pending the necessary resources to conduct the analysis, as part of a larger post-FSMA strategy to improve the safety of imported food. (Emphasis ours.)  In other words, let’s implement FSMA first, and then revisit the issue – by which point it may well be moot.