Advocacy at a Glance

Top-line: Congress is inching forward on the FY 21 appropriations process. However, neither the House nor the Senate has adopted rules permitting virtual committee mark-ups. Also hanging over the process is the tight budget ceiling for non-defense discretionary (NDD) programs. Various ways it might be solved and implications for FDA are discussed in this week’s Analysis and Commentary.House and Senate Appropriations Committees Still Committed, Off to a Slow Start. The House Appropriations Committee was supposed to start subcommittee mark-ups last week and have a first wave of bills passed by the full committee this week. Instead, the House Labor-HHS Subcommittee held a single hearing this week on COVID-19 and has not yet scheduled either hearings or mark-ups for next week. This week’s hearing was notable, as described in the next story and examined further in today’s Analysis and Commentary.In the meantime, Senate Appropriations Committee Republicans were scheduled to meet this week. According to Chairman Shelby, the topics to be discussed were: 302(b) allocations for subcommittees, the multi-billion dollar surge in VA spending that might require offsets through cuts to other non-defense programs, and how to proceed with markups. Neither the House nor the Senate has yet resolved a crucial step: whether the Appropriations Committees will be permitted to do virtual mark-ups.Impending Budget Cap Problems Might Be Resolved Through Creative Approaches. During this week’s House Appropriations L-HHS subcommittee hearing (can be watched here), one of the witnesses (Tom Frieden, former CDC director) proposed the creation of an off-budget Health Defense Operations fund. The subcommittee ranking member, Representative Cole, expressed interest in this approach. That exchange and the Senate Republican discussion about possibly taking some VA funding off-budget are indications that Republicans may not try to force FY 21 non-defense spending into the existing budget caps. The source of the problem and several proposals to address it are the subject of this week’s Analysis and Commentary.Senate Stays In-Session; House Expected to Return Next Week; CARES-2 CV Bill Will Take Time. A publication we read summed it up: “Everyone wants something in the next coronavirus bill.” By the time the House returns, which is expected to be the week of May 11, Speaker Pelosi is expected to have the outline of a CARES-2 bill combining additional funding for programs established in the last two months (such as small business support) and forging ahead on some new areas (such as assistance to state and local governments). There is no Republican support for this approach in either the House or the Senate.Senate Majority Leader McConnell has drawn a line and said that liability protections for businesses should be in the next package. This is as much of a non-starter as the emerging Pelosi package. Similarly, the President has advocated for a payroll tax cut in the next bill, which does not appear to have any significant support in the Senate or the House.Both House and Senate appropriations committees are trying to move forward (as described above) but it is not certain they will be able to make much progress with so much attention and disagreement over next steps to fight the pandemic and reopen the economy.  We anticipate that this stand-off on the CARES-2 bill will continue for a while, since Republicans say they would like to see the impact of the previous legislation before settling on the next package.FDA Assigned Many Tasks in Cures 2.0 Concept Paper. The 21st Century Cures Act, passed at the end of 2016, resulted in a number of changes at FDA, including new recruitment and hiring provisions. Representatives DeGette and Upton, the original bipartisan sponsors, have now released a Cures 2.0 concept paper (here). Among other things, the concept paper envisions FDA playing a role in assuring better access to medical care services for patients in clinical trials, accelerating development of a cross-agency policy on regulation of digital health, and facilitating generation of real-world evidence.