House Appropriations Committee Advances FY 24 Ag/FDA Bill - Senate Markup Set for Thursday, June 22

This week’s Analysis and Commentary provides a Q&A on the implications and consequences of the House Appropriations Committee mark-up of the FY 24 Ag/FDA funding bill. 

House Appropriations Committee Advances FY 24 Ag/FDA Bill - Senate Markup Set for Thursday, June 22. The House Committee on Appropriations on Wednesday, June 14, favorably reported the FY 24 Agriculture, Rural Development, Food and Drug Administration and Related Agencies bill by a vote of 34 to 27, with Members voting along party lines. 

Democratic opposition focused on the spending levels, which are significantly below the recent budget cap agreement.  Democrats also disagreed with policy riders included in the bill, including ones regarding mifepristone and tobacco.  

The Committee provides FDA with $3.504 billion for budget authority (BA) funding, which comes from taxpayer monies. Medical product user fees (human and animal) would be about $2.3 billion. 

This continues the division of FDA monies as 60% BA appropriation and 40% user fees. (The total of $6.5 billion for the agency includes $712 million in tobacco user fees, which are fundamentally different from medical product user fees).  

The draft report accompanying the bill can be found here. FDA’s appropriation starts on page 71, with the topline numbers, followed by more than 90 topics on which the Committee has provided its view. Subsequently, the Committee adopted a number of amendments to the report, which can be found here.

The Senate Appropriations Committee has now announced that the full committee will meet next Thursday, June 22, at 10:30 to consider Senate 302(b) allocations and to markup both the Military Construction/Veterans Administration bill and the Agriculture/FDA bill.  The Senate Agriculture/FDA Subcommittee is not expected to hold a formal markup in advance of the full committee markup.  

What They Said at the House Committee Markup That Affects FDA. Subcommittee Chairman Andy Harris (R-MD) focused his opening remarks on not continuing “down this path of spending large sums of money without regard to the fiscal future of our nation.”  In her opening remarks,  Full Committee Ranking Member Rosa DeLauro (D-CT) characterized the Committee bill as “misleading” and criticized the depth of cuts in domestic programs and the Republican decision to propose funding levels far below the budget agreement. 

There were an unusually large number of opening statements offered, resulting in a markup that lasted more than 6 hours. While dozens of issues and programs were discussed, much of the debate focused on amendments by Democrats to delete many of the riders included in the bill. All such amendments were defeated on party-line votes.  

With respect to FDA funding, Subcommittee Chairman Andy Harris said the funding levels provided by the bill would “enable the Agency to keep food, drugs, and medical devices safe and effective.” Full Committee Ranking Member Kay Granger (R-TX) characterized the bill as providing “a responsible level of funding for the F.D.A.”  

However, Ranking Subcommittee Member Sanford Bishop (D-GA) said “We must provide FDA with the resources for a robust inspection regime to hold both domestic and foreign drug manufacturers accountable. This bill falls short.”  

House Appropriations Sets Subcommittee Spending Allocations for FY 2024. In addition to marking up the Ag/FDA funding bill, the Committee discussed so-called 302(b) allocations that provide each subcommittee a spending limit within the total available funds. This caused heated discussions because the level proposed, when all twelve appropriations bills are considered, would come to about $119 billion below the agreed-upon amounts in the budget agreement. 

This is discussed in today’s Analysis and Commentary (here), in part because it prompted discussion around DC about the potential for a government shutdown in the Fall. 

Upcoming Alliance Webinar with FDA Oncology Deputy Director Dr. Paul Kluetz. The Oncology Center of Excellence (OCE) was established in 2017 to unite experts across the FDA to conduct expedited reviews of medical products for oncologic and hematologic malignancies. Dr. Paul Kluetz, Deputy Director of the OCE, will update us on the OCE–structure, resources, and advances. Join us on Tuesday, June 20th at 3:30 PM by registering here. 

Further Webinars in Development for Second Half of 2023. The Alliance for a Stronger FDA has two core missions.  The first is to advocate for responsible and adequate funding for an agency whose responsibilities are ever-growing and changing.  The second, related mission, is to help inform policymakers and thought leaders about the key role that FDA plays in our society and our economy.  Toward that end, watch this space in the weeks to come as we announce a  robust series of topical webinars through the rest of this year.