Heinrich Chairs Appropriations Subcommittee Hearing On FDA Budget Request
FDA Commissioner Dr. Robert Califf expressed “a wide range of concerns” about the potential future impacts of the recent ruling issues by a Texas federal judge on mifepristone
WASHINGTON - Today, at a hearing to review the President’s Fiscal Year 2024 Budget Request for the U.S. Food and Drug Administration (FDA), U.S. Senator Martin Heinrich (D-N.M.), Chairman of the Senate Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies, delivered opening remarks and offered questions for FDA Commissioner Dr. Robert Califf.
During his opening remarks, Senator Heinrich expressed his strongly held view that the “decisions the FDA makes, whether approving a medical device or approving a new drug, must be guided by science and not by political pressure.”
Senator Heinrich said that a recent federal court ruling by a judge in Texas has “undermined the FDA’s safety and efficacy determination of Mifepristone. And with it, he has undermined the FDA’s authority to determine the safety and efficacy of all medications – from insulin to cancer treatment.”
In response to Senator Heinrich’s question on the implications of the ruling for the FDA, Commissioner Califf stated, “We are concerned about the potential future impacts of this case, as reflected in the extensive briefs that have been filed by the Department of Justice on our behalf.”
Commissioner Califf continued, “This includes a wide range of concerns ranging from the well-being of patients, including women who need access to this drug, the pharmaceutical industry, and our ability to implement our statutory authority.”
Senator Heinrich recently joined over 240 members of Congress in submitting an amicus brief to the U.S. Court of Appeals for the Fifth Circuit in the case of Alliance for Hippocratic Medicine v. FDA.
The brief supports the Biden administration’s appeal of Judge Matthew J. Kacsmaryk’s ruling that suspends the Food and Drug Administration’s (FDA) more than 20-year-old approval of mifepristone, a safe and effective medication widely used in abortion care and miscarriage management for years. This ruling threatens access to mifepristone for patients nationwide, as well as FDA’s congressionally mandated independent authority and drug approval process.
During his questions, Senator Heinrich also asked Commissioner Califf about what the FDA is doing to address the opioid and fentanyl epidemic and how the FDA can better coordinate with the Centers for Medicare & Medicaid Services (CMS) on reimbursement for medications that are approved under the FDA’s accelerated drug approval process.
Senator Heinrich’s full opening remarks as prepared for delivery are below:
Good afternoon.
This hearing of the Agriculture Appropriations Subcommittee is now called to order.
I would like to begin by welcoming FDA Commissioner Dr. Robert Califf to this hearing.
Thank you for being here today.
I am looking forward to discussing the fiscal year 2024 budget request for the Food and Drug Administration.
The responsibilities of the FDA are tremendous. And they impact every American.
Last year, this committee provided historic funding for the agency.
But more work needs to be done.
That begins with the budget request in front of us today.
The request for FDA includes a discretionary increase of $372 million.
This increase touches a wide array of activities at the FDA from enhancing food safety to advancing safe and effective medical products, as well as continuing to address the ongoing opioid crisis.
We must ensure that the vast number of products FDA regulates are safe, while also not slowing down important advancements in research and technology.
That is no easy task.
But this committee stands ready to support the FDA and your critical work.
The decisions the FDA makes, whether approving a medical device or approving a new drug must be guided by science and not by political pressure.
Dr. Califf, with your long and distinguished career in science, I know you must feel the same way.
That’s why a recent decision by a federal judge in Texas is so disturbing.
This judge has replaced his political opinions for the scientific- and data-driven process used by the FDA.
He has undermined the FDA’s safety and efficacy determination of Mifepristone. And with it, he has undermined the FDA’s authority to determine the safety and efficacy of all medications – from insulin to cancer treatment.
I know we will discuss this shortly and I’m interested to hear your thoughts Dr. Califf.
But first, I look forward to hearing your testimony and having a robust discussion on this year’s budget request.
