Coming Soon: A Future Year of Massive Change

Four of our last five US presidents have served two terms. At the end of each 8-year cycle, there is the absolute certainty of massive change in DC. We don’t remember because the intervals are so long.Further, there are obscuring events that help us forget. From 8 years ago, I remember the financial crisis, but not much about the actual “changing of the guard.” Similarly, 16 years ago, I remember 9/11, but not much about the changes in leadership and policy that immediately preceded it. But a poor memory shouldn’t allow us to forget how different 2017 will be in DC -- more change will be involved than we can imagine. And the change will occur regardless of who is elected.To me, the transition to 2017 starts today. Congress will leave town for the conventions and campaigning. By the time they return briefly in September, all vestiges (and maybe all pretense?) of bipartisanship will be gone. The assumption is that there will be a lame-duck session, but I don’t think that is a certainty. Nor is it clear that much would be done if there were -- as a rule, lame duck session are long on promise and short on results, particularly with a new President coming and possible changes in the balance between the parties in Congress.Bipartisanship on public health issues is often an exception to political shutdown in DC, even in a Presidential election year. So, the opioid legislation went to the President this week (sans funding) and there are still chances for Zika legislation and the Cures/Innovations bills to pass. Other smaller initiatives are still on the table and may yet move. So, no one involved in health policy or FDA issues can relax, even though the environment for legislation is deteriorating rapidly.From FDA’s standpoint, it would be good to get a year with very little change -- no new legislative mandates, a well-entrenched commissioner and an increase in appropriated dollars -- because even if things are quiet, there is always more to do at FDA. If Congress doesn’t enact FDA-related laws, there is still the resource burden of growing globalization and increased scientific complexity.We can dream for a few minutes on what a quiet year at FDA would look like, but reality intrudes. Soon, there will be a new President, a new Secretary of HHS, possibly a new commissioner, and changes in Congress. Reauthorization of user fees will be on the clock starting in January with completion by early July a desirable goal. Loaded on this may be Cures/Innovations and multiple policy changes, as has been the case for the last few user fee reauthorization cycles.In addition to advocating for increased appropriated dollars for FDA, the Alliance’s mission included educating policymakers about FDA’s scope and responsibilities. FDA’s standing is always on our minds and will be a focus of Alliance activity through the rest of 2016 as we move into a year of massive changes.

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