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And Still We Hold Our Breath in Hope

December 11, 2015

To repeat a phrase used in an earlier commentary: no news is no news. December 11, the last day of the Continuing Resolution has now arrived and Congress is not yet ready to pass a year-long funding bill. A new CR will be adopted that runs through December 16. Meantime, Congress is slated to work this weekend on tax extenders, appropriations, and other items.

Eventually (hopefully next week), we will have a funding bill. It may provide FDA with as little as the FY 15 numbers — that is, level funding. Or the bill may include a small increase for FDA or maybe even a large increase made possible by the agreement to raise the budget ceilings for FY 16.

Whatever the number, the FDA will do the best it can with what it is given. More resources will allow greater progress on the Food Safety Modernization Act implementation, as well as fund medical product side initiatives in regulatory science, including increased effort on biomarkers.

We will all give a sigh of relief when Congress has settled this, hopefully with extra monies for FDA.

But before we get there, it is important to remember the toll that Continuing Resolutions and ongoing uncertainties places on FDA. Taxpayers get maximum value when FDA and similar agencies know on October 1 (or earlier) how much money they will have to spend. Imagine no inefficient stop orders, but rather knowing in advance the monies that will be available to implement the agency workplan without constantly looking over their shoulder.

How much more productive could FDA be … if on October 1, it knew how many vacancies can be filled and how many programs can be sustained and expanded?

For the moment, this is a dream. We will be fortunate if there is full-year funding legislation and not another short-term CR reaching into January. By then we will be even deeper into election year politics and resolution might prove more elusive, not less, in the new year.

Let’s hope it gets settled in the next few days.

Note: This week’s Analysis and Commentary was written by Steven Grossman, the deputy executive director of the Alliance for a Stronger FDA.

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