Advocacy at a Glance

Top-Line: House and Senate schedules for Appropriations mark-ups have been set, but not specific dates or bills. The earliest Senate mark-up would be the week of June 22 and the House would be after Fourth of July recess. All of this is subject to change. This week’s Analysis and Commentary builds the case for FDA exceptionalism as a reason for continued increases in FDA funding.House and Senate Set Schedule for FY 21 Appropriations Mark-Ups. The House Appropriations Committee announced that subcommittee and full committee mark-ups of FY 21 appropriations bills will commence the week of July 6 and continue the week of July 13. The intent is to have floor consideration of these funding bills starting the week of July 20. Thus far, the Committee has not specified dates or the order in which the bills will be considered.The Senate Appropriations Committee has announced that they will begin mark-ups the week of June 22 and finish the process after the Fourth of July recess. That is consistent with Republicans in the Senate indicating that they don’t want to consider another FY 20 coronavirus supplemental appropriations bill until later in July. Similar to the House, the Senate Committee has not specified dates or the order in which the bills will be considered. Additionally, Senate Majority Leader McConnell has not yet agreed to floor time for the consideration of funding bills.Further, the Senate subcommittees do not yet have their 302(b) subcommittee spending allocations, which are essential for completing draft bills prior to mark-up. Additionally, the Senate process could grind to a halt if Republicans propose allocations that move monies from Labor-HHS programs to pay for the border wall. Other possible barriers to moving bills forward are well-covered by Roll Call (here).House and Senate Likely to Follow Different Mark-Up Patterns. If past practices hold, the House is likely to mark-up a bill in subcommittee one week and full committee the next week. In contrast, the Senate usually marks bills in subcommittee on Tuesday and finishes the bills in full committee on Thursday of the same week. Often the Tuesday mark-up is pro-forma rather than substantive. The history of pro-forma sessions would be consistent with recent reports that the Senate Appropriations Committee might dispense with subcommittee mark-ups this year.FDA Updates Guidance on Clinical Trial Flexibility. The pandemic has made it hard for many clinical trials to continue, a problem which concerns the FDA and the stakeholder community. Last week, FDA issued an immediately effective guidance (here) updating prior guidance on conducting clinical trials of medical products during the current public health emergency.