Advocacy at a Glance

Budget and Appropriations: Progress But No Clear Path Forward. The budget and appropriations situation was extensively briefed in last week’s Friday Update (here and more here) and Congress has been in recess since then. A quick summary may be useful, however.Both House and Senate leadership have spoken about an expedited appropriations process with July 1 as a target date for passage of all 12 bills in the House and all 12 bills out of committee in the Senate. However, there are several preconditions for that to happen and progress is slow. Notably, there needs to be a deal to remove or replace the FY 20 budget caps in the Budget Control Act of 2011. Otherwise, defense programs will have to be trimmed by $70 billion and non-defense programs by $50 billion below the FY 19 enacted levels. House Speaker Pelosi and Senate Majority Leader McConnell have agreed to begin negotiations on this issue, but there was skepticism about finding a compromise and that has become further complicated by President Trump’s threat of a veto.Continuity at FDA a Key Theme as Post-Gottlieb Era Begins. When Anna Abram, a Deputy Commissioner at FDA, spoke to the Alliance on April 10, she stressed that outgoing Commissioner Gottlieb’s agenda would be largely intact, despite his departure. She expressed this as just not her own opinion, but what both Secretary Azar and Acting Commissioner Sharpless had told the FDA senior staff.That theme was further developed when Dr. Sharpless addressed an agency-wide meeting this week. He spoke directly to this point, stating:

Let me dispel any misconceptions that the change in leadership reflects some desire of the President or the Secretary for the FDA to go in a different direction from the Gottlieb era. That is not the case, Secretary Azar and the White House have been very clear with me that they have been impressed with the FDA’s efforts and would like to see this strong progress continue.

In his remarks, Acting Commissioner Sharpless stressed, among other things, the importance of FDA’s staff, the enormous breadth of FDA’s mission, and the importance of science-based decision-making. These are themes that have been central to the Alliance’s advocacy, so we are pleased to hear Dr. Sharpless place so much emphasize upon them.FDA During the Shutdown: Some Questions Still Need Answering. The Alliance was a source of information during the recent FDA shutdown. In addition to our weekly reports, we published an FDA shutdown toolkit that was widely circulated. It turns out that -- due to FDA’s vast responsibilities and multiple funding streams -- there are still a lot of questions on what funds can be spent (and which employees retained) “in the absences of appropriations.” To remedy this, the Alliance has written to FDA, asking a series of questions -- wanting both information and insights that would help the FDA stakeholder community in the event of a future shutdown threat. The letter is accessible here and is discussed in more detail in this week’s Analysis and Commentary.No Friday Update on April 26; Next Issue Will Be May 3. Not a hard and fast rule, but the second week of a Congressional recess is often a good time for a break. Things will be slow on budget and appropriations news until Congress returns the week of April 29. Our next edition, May 3, will cover movement on issues that concern FDA resources.