Advocacy at a Glance
Top-line: The House is expected to pass a resolution permitting virtual mark-ups during certain national emergencies. That should unlock the House appropriations process. The Senate appears to be making progress but still has not set out a pathway for consideration of appropriations bills. The House is expected to pass the next massive coronavirus legislation, which contains a number of provisions involving FDA. This is a preview of what legislation might look like, but any comparable Senate bill will be quite different.Virtual Mark-ups: Prerequisite for Movement of Appropriations Bills. Within Congress, there is some leeway to hold hearings virtually. If necessary, they can be called informal inquiries. There is no similar leeway on mark-ups, which require Members to be in the hearing room for purposes of establishing a quorum and voting. Without a mechanism for holding virtual mark-ups, the House will have great difficulty completing action on the 12 appropriations bills. This Friday (after publication time), the House is expected to remedy this problem, allowing virtual mark-ups in certain emergency situations. H. Res. 965 (text here; summarized here; explained here) is likely to be adopted over the objections of Republicans, can be implemented quickly, and should unlock the appropriations process in the House. Reportedly, funding bills have been readied in anticipation of this new procedure.In the Senate -- which has been in session the last two weeks -- the need for virtual mark-ups might not seem as great, However, anyone who watched the Senate HELP Committee hearing this week with Dr. Fauci knows that the number of Senators present in their DC offices is much smaller than might be supposed. So, discussions are probably still being held on permitting virtual mark-ups. Meantime, The Hill newspaper reports that
Republicans on the [appropriations] panel say they are hoping to hold committee votes on 10 of the 12 fiscal 2021 government funding bills by the end of June and potentially bring some of those to the floor in June as senators try to get legislation back on track amid the coronavirus pandemic.
FDA Plans for Reinstatement of Routine Inspections; No Timing Set Yet. In a May 11 release, FDA Commissioner Stephen Hahn, MD, announced that FDA is in the initial stages for renewal of routine surveillance inspections, both domestic and global. The agency will be working with CDC to determine the appropriate timing and the best ways to do this safely. A phased or gated approach is expected rather than a complete restoration of inspections at one time. Until that occurs fully, FDA will continue to do mission-critical inspections and use other monitoring tools to assure that FDA-regulated products and facilities—both food and medical—are safe.House to Pass Its Version of Next CV Legislation; Exploring What May Be in Store for FDA. Speaker Pelosi intends to move forward this Friday (after publication time) with House consideration of H.R. 6800 (text here; summary here), which is the next coronavirus relief bill. It encompasses nearly 2,000 pages and will cost in the vicinity of $3 trillion. Since it has no Republican support, it is being described as a Democratic wish list. Nonetheless, it represents mid-May thinking about areas into which FDA might be further drawn into the fight against COVID-19. This is explored in this week’s Analysis and Commentary.Frontiers in Science and Regulation: Individualized Therapeutics. The Alliance looks for opportunities to highlight areas where FDA’s responsibilities have broadened and deepened in response to scientific advances. One area we have mentioned previously is that new knowledge and technology make it possible to develop individualized therapies that treat a single person (so-called N=1 treatments). FDA explored a number of aspects of this in a March 3 CBER public workshop entitled “Facilitating End-to-End Development of Individualized Therapeutics.” A newly released transcript is here.