FY 23 CR for Sept 19; Preview for next year appropriations; Webinar with FDA One Health
FY 23 Continuing Resolution Expected to Move Week of September 19.
Outlook for Full-Year FY 23 FDA Funding.
CR vs. Appropriations: What’s at Stake for FDA?
User Fee Negotiations Ongoing.
Webinar September 27 at 11:30 a.m. “FDA and One Health.” with Dr. Steven Solomon, Director of the Center for Veterinary Medicine, and Dr. Namandjé N. Bumpus, FDA’s new Chief Scientist.
This week’s Analysis and Commentary looks at President’s Biden’s Executive Order on Advancing Biotechnology and Biomanufacturing Innovation and how it focuses upon and adds resources for FDA.
FY 23 Continuing Resolution Expected to Move the Week of September 19. No resolution was reached this past week regarding provisions that might be included in the upcoming CR. We continue to believe that the CR will fund the operations of the federal government from October 1 through December 16 at, for the most part, FY 22 spending levels.
Negotiations continue over what else might go into the CR in addition to funding for government programs. Additional aid for Ukraine is likely. An FDA user fee package may be included. Senate Majority Leader Chuck Schumer has said he intends to add a provision to the CR that will address pipeline permits, a matter of importance to Senator Joe Manchin, and controversial with other Democrats in both the Senate and House. Earlier this week House Majority Leader Steny Hoyer said that the CR will start in the Senate, which could force House acceptance of the Senate provisions.
As previously reported, FDA’s resources are capped under a CR, limited to the level of funds available in the prior fiscal year. There are also restrictions on the start of new programs, though modest effort in prior fiscal years can sometimes serve as a predicate for new activities under the CR.
Outlook for Full-Year FY 23 FDA Funding. Both Senate Appropriations Committee Chairman Leahy and Ranking Member Shelby are retiring at the end of this Congress. Not surprisingly, they would like to see FY 23 bills done. That is one of several factors in whether FY 23 appropriations bill are completed before the end of December.
The most significant factor is the outcome of the election. Presumably, if the Democrats retain both houses of Congress, they will be able to agree on appropriations bills. If Republicans take one or both houses, it will come down to whether to exert leverage on a year-end deal and to allow a clean start on FY 24…or to put their stamp on FY 23 bills after the new year.
CR vs. Appropriations: What’s at Stake for FDA? As described in last week’s Analysis and Commentary (here), a CR through December 16 will cost the agency the $229 million increase under the Senate bill or the $341 million increase under the House bill. Those monies may be recouped once appropriations bills pass, but in the interim the agency has less to spend. FDA must also proceed into the fiscal year with limitations on its ability to align funding, programming, and personnel.
User Fee Negotiations Ongoing. Negotiations on a final user fee bill are continuing through the weekend. Members are clear that user fees need to be enacted by October 1. So, the negotiations are focused on what else goes in this “must pass” bill.
Despite rumors of which provisions are in or out of the final package, nothing is set until the entire deal is done. If the Members have not yet agreed, it is hard to see how anyone else can do anything more than speculate.
While the content of the deal is yet to be determined, we expect the deal will be structured into three parts. The first and most imminent might be called “user fee plus.” It appears that Senator Burr is still trying to get a clean bill, while other principals (Senator Murray and Representatives Pallone and Guthrie) are fighting to include enough other provisions to make a robust package. Regardless of what is in “user fee plus,” there is likely to be a second package of provisions on which work will continue with the likelihood of a bill during the post-election session. Now, or perhaps during the post-election session, there may emerge another set of provisions that need a lot more work and might slip into 2023.
September 27 at 11:30 a.m. “FDA and One Health.” September 27, at 11:30 a.m. Our guests will include Dr. Steven Solomon, Director of the Center for Veterinary Medicine, and Dr. Namandjé N. Bumpus, FDA’s new Chief Scientist. REGISTER HERE.
“One Health” is an approach to solving health problems by recognizing the interconnection of people, animals, plants, and the environment. FDA is one of many federal agencies that support this approach and encourages its use. The webinar will explain the concept in more detail and feature presentations on how FDA’s work utilizes One Health.