Harris Remarks at FY25 Budget Hearing for the Food and Drug Administration

Apr 18, 2024

Statements

I want to thank everyone for joining us today as we review the Food and Drug Administration's fiscal year 2025 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 not only the budget request, but issues and challenges facing the FDA.

I want to recognize the critical work that occurs at the FDA touching the lives of every American, every day. While it is not always flawless, 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 once again acknowledge federal spending in general. We need to take a holistic look at our spending, on both the discretionary and mandatory ledgers. Every day Americans are being squeezed by unrelenting inflation, a product of years of overspending that only accelerated under the Biden Administration.

The Budget request put forth by the Administration while albeit more reasonable than previous years, it still increases federal spending and ignores our current fiscal environment.

For FY 2025, FDA's request totals $7.2 billion, which is $500 million above the FY 2024 enacted level. This increase includes approximately $160 million in new budget authority and $388 million from increased or new user fees.

I understand the marketplace is growing ever more complex and the FDA is constantly trying to adapt to the changes. I also realize there are business cases for certain increases or initiatives and this Subcommittee will fully analyze those. But I also know there is room for improvement in utilizing existing resources. Over the last ten years, FDA's budget authority has increased over $1 billion, 45%, in budget authority alone to meet operational needs, address crises, and invest in new technologies to advance drug and device safety.

Over the past few years, the Appropriations Committees - in a bipartisan and bicameral effort - have been pressing FDA to be more transparent in how resources are being utilized. I acknowledge FDA has taken some steps to be more transparent with spending, but more work remains. As I noted, the budget request seeks an additional $500 million, which is a significant increase. This Committee needs more transparency to know what is happening with the resources we have already provided, and we want to work constructively with the FDA to maximize resources. Funds that we provide in FY 2025 need to come with accountability measures.

Aside from funding, I have concerns on certain actions that have taken place at the FDA resulting in credibility challenges in the eyes of the public.

First, as a doctor I have serious concerns about the actions FDA took when recommending to the Drug Enforcement Administration the rescheduling of marijuana. The two-factor authentication test utilized by FDA lacks both substance and data. It seems the FDA ignored several important factors when considering marijuana's potential for abuse and harm to public health, including but not limited to daily marijuana use, health damage caused by traffic fatalities due to individuals driving under the influence of marijuana, and the impact of marijuana use on pregnant women and children. We can talk about this more in depth, but I have long said the American people deserve to know the effect modern marijuana has on the human body.

I am also very concerned about widespread drug and device shortages. This year we've unfortunately broken the record for drug shortages with a record 323 medications in shortage. Many of these shortages are caused by safety concerns identified in overseas manufacturing facilities in China and India. Rather than FDA shifting its focus to react to the shortages when they occur, we need to work together to address the root causes of the shortages. I'd like to further discuss FDA's regulatory oversight of imported drugs and opportunities to bolster domestic manufacturing, particularly for generic drugs.

On the Foods side, we are looking forward to the establishment of the unified Human Foods Program and establishing a new model for the Office of Regulatory Affairs (ORA). ORA performs many of the FDA's field-based operations and will be renamed the Office of Inspections and Investigations (OII). We are ready to see the anticipated improvements these reforms will bring and recognize the effort that has gone into this reorganization. This undertaking will hopefully go a long way towards instilling some of the confidence that has been lost in recent years.

Unfortunately, other controversies continue to swirl around the Agency, disrupting public confidence in particular FDA's continued inability to clear the market of illicit tobacco products. I simply do not understand why FDA cannot - or will not - tackle this problem head on and get illicit products out of the marketplace. This should be the Center for Tobacco Products' number one focus, not dreaming up new rulemakings to further exacerbate black markets.

Dr. Califf, we are eager to hear how you will address these issues. I look forward to working with you, and I appreciate you being with us for today's hearing.