Harris Remarks at FY24 Budget Hearing for the Food and Drug Administration (As Prepared)

Mar 29, 2023

I want to thank everyone for joining us today as we review the Food and Drug Administration’s fiscal year 2024 budget request. Our witness is the Commissioner of the Food and Drug Administration, Dr. Robert Califf.

Dr. Califf, I want to welcome you to today’s hearing.  I look forward to the discussion on the budget request and other topics of importance.  

Without a doubt, the FDA does critical work that touches the lives of every American, every day, and America continues to be blessed with the safest food and drug supply in the world.  But as I look at the FDA’s budget request, I’d be remiss if I did not acknowledge the fiscal outlook facing the country.

The Congressional Budget Office’s most recent outlook shows that this administration has done more to increase our national debt than any other administration.  We simply cannot afford to keep increasing the deficit. We genuinely need to start having an honest conversation about how to reign in Federal spending that is driving inflation and weakening the economy. 

Unfortunately, the Budget request put forth by the Administration hides from this reality and once again contains an expansive unrealistic wish list.   

For FY 2024, FDA’s request totals $7.2 billion, a significant increase. This is a $522 million increase, or 8 percent, above the FY 2023 enacted level. The $522 million increase includes $372 million in new budget authority and $150 million from new user fees. The budget authority increase alone is over 10 percent above FY23. 

This Subcommittee has made significant investments in the Agency. Since 2018 the Agency’s budget authority has increased by 25 percent.  I recognize there may be an argument for additional resources at the Agency, and the marketplace is growing ever more complex. 

But I also know there is room for improvement in utilizing existing resources.  There remains a lingering concern over the lack of transparency related to the execution and utilization of the existing budget, particularly on the Foods side.

There have been several occasions when questioned about resources, and the Agency has not been able to provide answers.  This lack of transparency and accountability in resource management does not instill confidence to make additional investments on our end. 

I know the Center for Food Safety and Applied Nutrition houses the researchers and policymakers while the Office of Regulatory Affairs is home to the inspection and compliance workforce. I am concerned that presently they do not work together to execute their respective budgets.  There has not been enough oversight and monitoring of funding increases the past couple of years.  I intend to look deeper into how all existing resources are being used to ensure we maximize the efficient use of all resources, particularly as the Agency undergoes structural reform of the Foods program in the coming months. 

We are all interested in learning more about how you will restructure, reform, and improve operations in the Foods program. I understand this could not be addressed in the Budget itself, but there remains significant bipartisan interest in how the agency will remedy what many see as dysfunction that is adversely impacting the agency’s ability to protect consumers while also possibly delaying or stifling innovation. 

I know you are keenly aware of how vocal stakeholder groups have been on the restructuring proposal.  And given the Politico article from Monday titled, “Lessons have not been learned: FDA knew of positive test months before latest infant formula recall,” I expect stakeholders to be even louder.  FDA continues to be passive and reactive when it comes to infant formula inspection activities when surely everyone at the Agency knows infant formula is in the spotlight.

Additionally, other controversies continue to swirl around the Agency, disrupting public confidence in the FDA.  High-profile incidents including findings of “atypical collaboration” between a drug manufacturer and the FDA on an Alzheimer’s drug, the inability to clear the market of illicit tobacco products, and not identifying a regulatory pathway for cannabidiol oil after five years and millions of dollars of investments from this Subcommittee to name few.  Many Americans also refused to get a COVID vaccination due to government distrust.  We need to quickly remedy what is not working in the Agency, institute needed reforms, and restore public confidence. 

As I stated last year, I believe that many of the problems facing the FDA can be solved through strong leadership and not necessarily with more money.  I stand by that statement.

I am sure all of us are eager to hear how you will continue to address recent challenges the Agency has faced. I look forward to working with you, and I appreciate you being with us for today’s hearing.