VIDEO: Heinrich Questions FDA Commissioner on Avian Flu, Infant Formula Supply, Illicit Vaping Products, and Mifepristone

WASHINGTON - Today during a hearing to review the Fiscal Year 2025 (FY25) Budget Request for the Food and Drug Administration (FDA), U.S. Senator Martin Heinrich (D-N.M.), Chairman of the Senate Appropriations Subcommittee that oversees funding for the FDA, urged FDA Commissioner Dr. Robert Califf to prioritize preparation for virus threats from livestock, inspections at infant formula facilities, and addressing illicit vaping products, and reinforced the safety of mifepristone.

VIDEO: U.S. Senator Martin Heinrich questions FDA Commissioner Dr. Robert Califf, focusing on Avian Flu, infant formula supply, mifepristone, and illicit vaping products.

On Avian Influenza

Heinrich asked Dr. Califf about contamination in food and milk caused by the recent Highly Pathogenic Avian Influenza outbreak, commonly known as the bird flu. Dr. Califf shared the need to prepare for the possibility of the virus jumping from animals to humans. Dr. Califf said, "We must have testing, antivirals, and we must have the vaccine. We have been busy getting prepared for if the virus does mutate in a way that could jump to humans on a larger level."

On Infant Formula Supply

Heinrich questioned Dr. Califf on infant formula management. Heinrich asked, "How do you see infant formula being managed under the new human food program?"

In response to Heinrich, Dr. Califf shared how the FDA will reorganize to better respond to the needs of working families. Dr. Califf said, "We have hundreds of people across the FDA who have volunteered to be champions of change in this massive reorganization. But, in the interim, because of the urgency of the infant formula issue, we've already done a lot of the work that we had to do. We now have many more people working on ... science and regulation that needs to go on. All of the infant formula facilities are being inspected at least once a year and in the case of the Abbott plant, there is a consent decree, so we are essentially there every day."

On Mifepristone

Heinrich additionally asked about the efficacy of mifepristone. Heinrich asked, "Is mifepristone safe for patients?" Mifepristone is an FDA-approved medication that is sometimes called the 'abortion pill', as it is used to end a pregnancy through ten weeks gestation.

In response to Heinrich, Dr. Califf stood by the FDA's research and conclusion. Dr. Califf said, "We stand by the decisions of the FDA over the years and the constant looking at surveillance data and clinical trials when they come in. Mifepristone is safe and effective."

On Vaping

Finally, Heinrich questioned Dr. Califf on FDA's lack of urgency to roll out vaping regulations. Heinrich said, "Why are we not making faster progress on regulating the incredible number of unapproved vaping products that are on the market?

Dr. Califf said, "I'm as frustrated as you are with it." Dr. Califf continued, "Just as we're getting a handle on the basics of vaping...along comes the Chinese manufacturing of vaping products and the overwhelming vaping products now used by American youth and getting addicted is made in China...Here we have products that are not legal to sell to Chinese people in China, made in China, and imported into the United States in large numbers...If we take our 1400 investigators, i.e. inspectors, and try to have them manage 300,000 vaping establishments, that math doesn't work. So, we've got to stop this at the point of import."

Chairman Heinrich's opening statement, as prepared for delivery, is below:

Good morning.

This hearing of the Agriculture Appropriations Subcommittee is now called to order.

I would like to begin by welcoming FDA Commissioner Dr. Robert Califf.

Thank you for being here today.

I look forward to discussing the fiscal year 2025 budget request for the Food and Drug Administration.

The responsibilities of FDA are vast and impact the lives of every American.

We need to ensure you have the resources to continue your critical mission. And I am committed to working with you during the appropriations process to provide the funding you need.

That begins now with the Fiscal Year 2025 budget request in front of us. The request includes a total of $3.695 billion in discretionary funding, a $168 million increase. This is a relatively modest request for the agency.

I am interested in hearing about your priorities within this budget request, Dr. Califf.

And what role this Committee can play in ensuring we continue to have the world's safest food and drug supply.

I will say that I am frustrated with FDA's lack of urgency in regulating the tobacco products and e-cigarettes that are flooding the market.

I am also concerned with the Highly Pathogenic Avian Influenza and it's potential impact to our food supply.

I continue to be interested in investing resources into our domestic infant formula supply as we continue to recover from the 2022 formula shortage crisis.

All of these issues continue to be public health threats to our nation and the FDA should be using all tools available to address them.

I look forward to hearing your thoughts on these issues and what FDA is doing to address them.

Dr. Califf, I want to reiterate my continued support for FDA and the dedicated employees of the agency.

Last year, we had to make difficult decisions under grim spending caps. I'm afraid this year will not be much better.

This is why it's important to hear your priorities and the priorities of all members of this committee.

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