"The Best of Times" ... "The Worst of Times"

It is the Alliance’s purpose to educate about, and advocate for, increased appropriated resources for the agency. We will talk to anyone (and try to talk with everyone) about FDA’s growing responsibilities and the need for resources to fulfill its mission and serve the needs of the American people.Ultimately, success is measured by the level of funding that Congress chooses to provide the agency each fiscal year. Relevant considerations: How much did the President request for FDA? How much do the House and Senate subcommittees have available to spend on FDA? And particularly pertinent: Does Congress perceive that FDA monies are well spent and that there is a strong rationale for prioritizing FDA funding over other pressing demands?By this standard, FDA and the Alliance should have had a good year. The President requested a $400 million increase for the agency in FY 19. Congress, despite competing priorities and less money to spend, nonetheless is prepared to provide FDA with somewhere between a $159 million increase (Senate) and a $307 million increase (House).

And yet, a happy ending is far from assured. FDA’s increase, along with monies for every other currently-unfunded agency in the federal government, is impacted by “macro-budgetary” considerations, factors that are completely divorced from the merits of individual agencies.The current situation can be summed up as follows: There are seven funding bills that have not passed (about one-third of all federal discretionary spending) and none of them are likely to move forward unless the White House and Congress can agree on funding for the southern border wall championed by the President. But for that fight, probably four of the bills (including Ag/FDA funding) could be passed and become law before the current Continuing Resolution (CR) expires on December 7. Of the three others, there appear to be some tough issues to resolve in two of them, but nothing on which compromises could not be found. So, the remaining bill, encompassing Homeland Security funding, is holding up movement on the others.There are a few possibilities for what happens next -- none of which are based on the merits of giving FDA increased funding, but all of which will affect the resources available to the agency. The White House could decide it has sufficient leverage in negotiations, such that it doesn’t need to block all seven bills. If so, there is a good chance that Ag/FDA funding could advance because of the political and electoral clout of the farm community.

More likely, negotiations will continue next week and probably into the week or two after that. A new CR would be needed after December 7 to avoid a partial government shutdown. If negotiators don’t feel progress is being made this year, then a further CR might extend funding into the new year. If the negotiations seem hopeless, then it is possible that a CR could cover one or all of the unfunded agencies through September 30, 2019. That is the worst case for FDA -- it would lose all hope of increased funding and have to operate with certain program restrictions.As a result of the collective efforts of FDA, its Congressional advocates, and the stakeholder community, things have been looking bright. We will continue to keep you informed about whether macro-budgetary considerations are dimming that prospect.

Editorial note: The Analysis and Commentary Section is written by Steven Grossman, Deputy Executive Director of the Alliance for a Stronger FDA.