Advocacy at a Glance

Top-Line: Acting CDER Director Patrizia Cavazzoni, MD, and Director of the Office of New Drugs Peter Stein, MD, have accepted our invitation to speak at a special Alliance webinar, scheduled for September 28. A Continuing Resolution (CR) to continue government funding after October 1 is inevitable. The important details are still missing: when will it pass, how long will it run, and what other legislation will be tucked into it. This week’s Analysis and Commentary explores the concept of a Health Defense Operations (HDO) fund and its possible implications for FDA.Reminder to Media: The Alliance's Advocacy at a Glance and Analysis and Commentary posts are on-the-record. Further, we are always available to both our members and media to answer additional questions.Dr. Cavazzoni and Dr. Stein to Address FDA Members and Media on September 28. We are honored that Acting CDER Director Patrizia Cavazzoni, MD, and Director of the Office of New Drugs Director Peter Stein, MD, have accepted our invitation to speak at a special Alliance webinar, scheduled for September 28 from 3:00 to 4:00 p.m. To sign-up to participate, please contact Reed Diskey. The event is limited to Alliance members and media. If you are not a member and would like to participate, please contact Steven Grossman.Congress Expected to Pass a Continuing Resolution in September, but Key Details Remain to be Resolved.  A​ Continuing Resolution (CR) to continue government funding beginning October 1, long expected, has now reached the point of inevitability. The important details are still missing: when will it pass, how long will it run, and what other legislation will be tucked into it. The report on Friday morning that House Speaker Pelosi and Treasury Secretary Mnuchin have reached an agreement on a CR actually doesn’t change the fact that all the important details are still missing.Gamesmanship is expected on the CR. The action is likely to start the week of September 14, when the House next has votes scheduled. Before that occurs, the House will have to decide whether it wants to combine the next pandemic supplemental appropriations bill with the CR. Latest indications are “No,” not least because the House and Senate are wide apart on the pandemic bill. The House has no interest in the CR being held hostage over resolution of pandemic differences.In contrast, Senate Majority Leader McConnell is expected to push for a “skinny” pandemic supplemental package to be added to the CR. He is in a delicate position. Twenty members of his Republican majority are on the ballot in November and at least seven are in tough races. McConnell wants to sends them home to campaign, but knows they will be at a disadvantage if Congress hasn’t passed additional pandemic relief legislation. The House doesn’t need a bill so badly or so quickly and says it will only accept a full pandemic relief package.This back-and-forth will take place against the hard deadline of September 30. No one would benefit from a shutdown. Short-term CRs of a few days or a week are a possibility. The House isn’t scheduled to adjourn until October 2 and the Senate until October 9. But McConnell will want to adjourn sooner and short-term CRs just postpone reaching a deal and prolong the time Members are in DC.FY 21 Funding After the Election: a Deal is Cut or CRs are Extended into 2021? Somehow the CR will pass and is likely to extend into the first half of December (post-Thanksgiving). Congress will plan to address appropriations then, when it is safer to address hot-button issues. Conventional wisdom is that those who win the election will extend that CR into February or March of next year. Then, funding issues are decided when they will have control. Conversely, the losers want to cut post-election deals while they still have some degree of control.It could happen that way, but the dynamic is not necessarily “winners and losers.” For example, the winners could decide that it makes sense to cut a deal -- on terms more favorable to themselves -- for FY 21 funding and then concentrate next year on getting their policy priorities into FY 22 funding. And, of course, winners and losers will have a different (and unknown) set of dynamics if we continue to have divided government.