A "Breather", a Summary Review, and a Re-commitment

After non-stop action all year, Congress finally paused and took a hiatus for most of August. By next week, they will be back, with a lot to do and not much time to do it. The focus will be on macro-budgetary items -- that is, the entirety of federal spending (about $4 trillion, including entitlements and debt payments). FDA-relevant considerations include the annual budget deficit, appropriations subcommittee allocations, and caps on total defense and non-defense spending. Put simply, if there are more non-defense dollars to spend, FDA is better able to vie for an increased appropriation.In contrast, almost the entire year up to now has been dominated by FDA-relevant micro-budgetary issues. That is: How much did the President request for FDA? How much will the House and Senate appropriate? And particularly pertinent: Does Congress perceive that FDA monies are well-spent and that there is a strong rationale for prioritizing growth at FDA over other pressing demands?Advocacy for FDA resources is a year-round cause, so we were quite busy at the end of 2016 and in the first quarter of 2017. We talked with the HHS transition team, House and Senate appropriators, OMB, and the Administration’s FDA landing team. We found that support for FDA was strong -- manifested and reinforced by Congressional passage of 21st Century Cures in December 2016.In the President’s March “skinny budget,” we learned that the Administration wanted to substantially increase medical product user fees, while implying that FDA’s aggregate budget might stay level or increase. This demonstrated strong Administration commitment to FDA -- definitely a good thing and not something we took for granted given the President’s proposed 15-20% cuts at the Departments of Agriculture and Health and Human Services.We anticipated, correctly, that the final Administration request released in May would (1) offer user fees well above the increases negotiated between industry and FDA and (2) propose large offsetting cuts to budget authority (BA) appropriations. It soon became evident that the authorizing committees were committed to the 2-year-long, good-faith negotiations and included those levels (rather than the Administration’s) in the user fee reauthorization legislation (FDARA).Subsequently, the House and Senate appropriations committees took a consistent position, choosing to provide FDA with level BA funding (not the proposed cuts) plus the $60 million made available by the 21st Century Cures legislation plus the user fee funds authorized by FDARA. We await the fate of the “mega-bus” appropriations bill, which includes Ag/FDA spending. A vote by mid-September is expected, but it is unclear whether that will result in regular funding by October 1 or require a continuing resolution.We continue to express our thanks to Congress and the Trump Administration for their commitment to a strong FDA that requires more funds to fulfill its mission. To reinforce this message with Congress -- especially for its support of BA and Cures funding -- please participate in the Alliance’s Hill Day on September 19. By “making it personal,” we can express appreciation and reiterate our message and concerns.Editorial note: The Analysis and Commentary Section is written by Steven Grossman, Deputy Executive Director of the Alliance for a Stronger FDA.