Alliance Reaction to House Subcommittee Markup

This week’s Analysis and Commentary describes the macro- and micro-budget processes and their impact on resources available to FDA. Stakeholders belonging to the Alliance contribute to our advocacy, education, and analysis that supports a well-funded FDA. 

House Subcommittee Advances FY 24 FDA Funding; Full Committee Mark-up Likely Next Week. On Thursday, May 18, the House Ag/FDA Appropriations Subcommittee marked up FY 24 funding legislation. This is the beginning of an appropriations process likely to stretch over the next three to five months. The draft subcommittee bill can be found here. The committee report accompanying the bill is unlikely to be publicly available until the full committee mark-up, which is likely to occur the week of May 22. 

The subcommittee adopted an FY 24 funding bill proposed by the Republican majority. It provides $3.5 billion in budget authority (BA) funding for FDA. This represents flat funding of budget authority (BA; taxpayer-funding) relative to the FY 23 level. This is in line with allotments to other major programs in the Ag/FDA bill, all of which received flat funding or slightly more or slightly less than their current funding levels.

The subcommittee mark does not fund any of the $372 million increase proposed by the President for program needs in: food safety, cosmetics safety, opioids, cancer moonshot, medical device supply chain shortages, ACT for ALS, infrastructure and regulatory science, and mandated pay raises. Also, the subcommittee mark does not provide for any program growth to meet FDA’s increasing workload or any monies for program upgrades and reforms for food safety, or money for FDA to implement the new cosmetics safety law.

The subcommittee mark does not fund pay raises for which the agency will have to absorb approximately $105 million in costs. The subcommittee mark also does not appear to fund buildings and facilities ($12 million in FY 2023).

About one-third ($8 billion) of the proposed total Ag/FDA Subcommittee mark is funded with unspent pandemic monies proposed for rescission and clawbacks. That offset won’t be available in subsequent fiscal years and implies major cuts for all discretionary Ag/FDA programs in FY 25 and thereafter.  

Alliance Reaction to House Subcommittee Markup. The Alliance is understandably concerned about the flat funding provided in the subcommittee’s draft bill.  In all of our Hill meetings and in our statements to the House and Senate Appropriations Subcommittees we supported the Administration’s request for $3.914 billion in BA funding for FDA in FY 24.  As described above, it effectively means FDA will not be able to do all that it needs to or should be doing in FY 24.

We also recognize this is the first step in a multi-month process.  We will continue to urge funding at the levels requested in the budget and will be actively working towards that end.

Webinar on June 5 with FDA Chief of Staff Julie Tierney on FDA Staffing. The Alliance’s webinars on the FDA’s FY 24 budget request had one common theme—FDA staffing issues including vacancies, hiring incentives, recruitment, retention, and training. 

To provide a comprehensive overview of these issues, Julie Tierney, the FDA’s Chief of Staff, will be the featured speaker on an Alliance webinar scheduled for Monday, June 5, at 1 p.m. Sign up here.

Alliance members are encouraged to submit questions in advance to Steven Grossman so that we can be sure the program is responsive to the information that stakeholders most want to know.

Webinar on June 20 with Dr. Paul Kluetz, Deputy Director of the Oncology Center of Excellence. In a return appearance scheduled for Tuesday, June 20th at 3:30 PM ET, Dr. Paul Kluetz, Deputy Director of the OCE, will update us on the OCE–structure, resources, and advances. To RSVP, please click here and fill out the sign-up form.   It has been 18 months since the Alliance held a webinar on the FDA’s Oncology Center of Excellence (transcript here). 

FDA Creates New “Rumor Control” Webpage to Combat Misinformation. Commissioner Califf often speaks about the harm to public health from medical and scientific misinformation. 

To combat this within FDA’s broad jurisdiction, the agency has created a new webpage, aptly titled “Rumor Control.” It is aimed at the spread of rumors, misinformation, and disinformation about science, medicine, and the FDA.  It urges “get the facts and learn about what the FDA does for you every day.” The website is here.