AdComms and the #Shutdown

People are looking for black and white answers about what government agencies in general are going to do during the shutdown respecting specific operations.  One of the specific areas of interest at FDA has been whether or not there will still be advisory committee meetings.

If you perform a Google search of “FDA Advisory Committees Government Shutdown” you will get a mixed bag in response – everything from FDA activities will continue to FDA postpones AdComms.  So it turns out the answer is not black and white.  It is gray.  It is maybe.  It is “it depends”.

FDA has put up a very nice and thorough page on “Medical Product Activities During the Federal Government Shutdown” that is meant to summarize agency activities during the “lapse period” as they have termed it.  In it, they state that FDA’s activities during the period will be limited to work involving eh safety of human life or the protection of property and activities funded by carryover user fee balances under PDUFA, GDUFA and MDUFA.

As to product reviews, the agency states that they “do not anticipate that the lapse in appropriations will affect our routine product review process submissions within the scope of PDUFA or GDUFA programs, provided that the applicable fees were paid before October 1, 2013.  This may lead some to report that the shutdown will not be affecting FDA Advisory Committee meetings.

But on October 8, FDA announced that it was postponing the Allergenic Products Advisory Committee set for November 5 and 6 “due to the government shutdown.”

Without knowing the specifics of that particular meeting, the bottom line would appear to be that AdComms regarding user fee products should still be able to continue if they were already paid for this year, though the logistics may be different or hampered in a way that makes them different from meetings in the normal course of things.  For example, the FDA press office has limited support at this time.  In the end, it would appear whether or not a meeting is going to occur is going to be assessed on a case by case basis, with the user fee question a key to that assessment.

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