Prospects for Government Shutdown Increase Without Progress on Continuing Resolution

The Alliance is a resource to the entire FDA stakeholder community. We welcome your questions about FDA and what may happen should there be a government shutdown (send questions to sgrossman@strengthenfda.org). 

This week’s Analysis and Commentary continues that process by addressing some of the most frequently asked questions about FDA and a government shutdown. 

Prospects for Government Shutdown Increase Without Progress on Continuing Resolution. With only fifteen days before the end of the fiscal year, neither the House nor the Senate have advanced a Continuing Resolution (CR) to provide funding for the operations of the federal government when the new fiscal year starts on October 1. There have been reports of various options under consideration, but no exact plan has emerged. 

House Freedom Caucus members continue to say they will oppose any CR that does not involve spending reductions and certain policy riders, while Senate leadership says they want to maintain current levels of operation in a clean bill while resolving FY 2024 appropriations.   A further source of disagreement is likely to center on supplemental funding for disaster relief and Ukraine.  

As we noted last week (here), the Alliance has started to update materials that we have used to inform stakeholders and media during prior shutdowns and shutdown threats. Meantime, please send any further questions to sgrossman@strengthenfda.org. 

Senate Adjourns until Monday with Appropriations Action Pending. This week, the Senate began considering the FY 2024 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations bill as part of a minibus with two other appropriations bills. 

With a decisive 85 to 12 vote to invoke cloture on the minibus, the Senate was poised to move forward. Progress was halted when there was an objection to a motion for unanimous consent to proceed to the consideration of amendments. The objection came from Senator Ron Johnson (R-WI), who urged the Senate to move forward separately on each of the three bills in the minibus. His expressed reason was to mirror the House, which is considering bills separately. He may have also intended to “slow” the Senate for the House to “catch up,” as a way to help House Speaker McCarthy. At week’s end, negotiations were ongoing to see if Johnson’s objection could be resolved. The Senate has now adjourned until Monday, September 18.

House Puts Ag/FDA Appropriations Aside; Poised to Consider Other Bills. The House’s attempt to move forward on Ag/FDA appropriations was put aside with no time framework for its subsequent consideration. Speculation centered on the inability of moderate and conservative Republicans to agree on what, if any, provision should be in the funding bill related to limiting access to the abortion drug mifepristone. The Senate does not have a similar provision and the Administration has included opposition to the provision in its Statement of Administration Policy. 

Instead of the Ag/FDA bill, the House intended to consider the Defense Appropriations bill this week. That was also pulled down when it became apparent that the rule setting the conditions for debate would be defeated.  Action may take place next week. 

FDA Funding Supported in Statement of Administration Policy on Senate Minibus.  In a positive development for the FDA, the White House issued its Statement of Administration Policy (page 3) in support of the Senate’s proposed level of FDA funding and strongly encouraged additional funding to maintain FDA program and staffing levels:  

“Department of Health and Human Services (HHS) Food and Drug Administration (FDA). The Administration appreciates the targeted increase of $20 million in the Senate bill. The Administration does have some concerns that at that level, FDA would need to absorb the statutorily required pay increase for staff. In order to maintain current FDA staff and service levels, this would require FDA to take funding from other programs to meet the need. This would impact FDA’s ability to maintain current levels of oversight on activities such as food safety and medical product review. The Administration would like to work with Congress to ensure that there is sufficient funding to support the staff necessary to allow FDA to meet its core public health mission to keep food safe and ensure medical products are safe and effective.”

Upcoming Webinar on FDA and AI. 

Our guest: FDA’s Acting Assistant Director of Digital Health Policy MiRa Jacobs, Ph.D.  

September 19 from 11 to noon. Please register here!

Artificial intelligence and machine learning (AI/ML) are profoundly impacting health care and medical product development and manufacturing. The scope of change is only going to increase in the future. FDA’s Digital Health Center of Excellence is at the center of conversations to ensure innovations in this space serve to assist FDA and benefit the American public. 

We have asked Dr. Jacobs, FDA’s Acting Assistant Director of Digital Health Policy, to discuss the integration of AI/ML into FDA’s regulatory framework and also the challenge of recruitment and staff training in this area.