Further Appropriations Action Yet to be Scheduled

This week’s Analysis and Commentary explores the impact on FDA if Congress cannot agree on FY 24 Appropriations bills and a sequester goes into effect. 

Further Appropriations Action Yet to be Scheduled. The House Appropriations Committee approved HR 4368 on June 14, and the Senate Appropriations Committee approved S. 2131 on June 22,  the Agriculture, Rural Development, Food and Drug Administration and Related Agencies Appropriations bill.  As we have previously reported, the House bill provides FDA with $3.504 billion for budget authority (BA) funding, which comes from taxpayer monies.  The Senate bill provides $3.550 billion for FY 2024, an increase of $20 million over the FY 2023 enacted measure.  

The House and Senate Appropriations Committees had expected to complete action on all individual appropriation bills by the end of July. As of press time, neither the House nor the Senate have announced a schedule for full consideration of their respective bills.  There are only eight legislative days remaining in July on the House and Senate calendars at this time, with only 12 legislative days in the House and 17 in the Senate for September.

The increase in the Senate Ag/FDA bill is enabled by a higher 302(b) allocation, with $25.993 compared with $25.6 billion in the House ($17.8 billion in budget authority coupled with nearly $8 billion in claw-back funding and some rescissions). Total budget authority allocations under the Senate measure are $1.59 trillion, the same spending limit as the amount negotiated by leadership and the White House on the debt limit deal, compared with $1.47 trillion under House allocations. These differences (especially the $120 billion difference in total funding) will need to be resolved before the appropriations process can be completed. 

The House Freedom Caucus (HFC) has complicated the situation by insisting on further dramatic decreases in federal discretionary spending. They plan to vote against any bills that might create a top-line spending level that would be higher than the FY 22 level.

House Democrats will oppose any rollbacks and it is believed that a significant number of House Republicans do not support the HFC position. As a consequence of this uncertainty, it has been suggested that the House could take up a Continuing Resolution as early as this month to avoid the potential shutdown of the federal government on October 1.

Upcoming Webinar: FDA Chief Scientist Dr. Namandjé Bumpus. August 2nd from 11am-12 noon. Please register here!

The Office of the Chief Scientist (OCS) is a hub for scientific programs that support the Centers and the overall FDA mission, including regulatory science, NCTR, technology transfer, and FDA's Medical Countermeasures Initiative (MCMi). The Office of Cosmetics and Colors will be moved into OCS in the near future. 

Upcoming Webinar: FDA Commissioner Dr. Robert Califf. August 16 from 1 to 2 p.m. Please register here!

The Commissioner’s February 2023 webinar with the Alliance (here) was one of our most informative, providing an opportunity for multiple topics and multiple stakeholder interests to be discussed. Dr. Califf has agreed to do another fireside chat with us in August. If you are interested in FDA priorities, this is a must-see event. 

Upcoming Webinar: FDA Chief Ombudsman Ms. Laurie Lenkel. August 30 from 2 to 3 p.m. Please register here

The FDA Office of the Ombudsman is the agency's focal point for dispute resolution of complaints and disagreements between companies or individuals and FDA offices. They serve as consultants, mediators, and oversee formal dispute resolution mechanisms. Their goal is to assure fair and even-handed application of FDA policy and procedures.

Did You Know: The Alliance Has Posted Transcripts of Our Webinars with Senior FDA Leaders. In the last 18 months, the Alliance has sponsored 25 webinars with senior FDA leaders, including the Commissioner, the Principal Deputy Commissioner, all five Center Directors, and many others. Transcripts can be found on our website at: https://www.strengthenfda.org/events. These provide a great opportunity to learn more about FDA’s priorities and programs.

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Floor Action on House Ag/FDA Appropriations Bill May Be Next Week

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FDA and the Threat of Sequester