March 05, 2024
Happy Tuesday! Here's a look at how the six-bill minibus could deliver the Food and Drug Administration some needed budget certainty but still force tradeoffs.
You won't hear from us if the minibus passes as everyone expects, because you can get that news anywhere.
- If it blows up for some reason, we'll be back in your inboxes ASAP with our best reporting on what happens next.
1 big thing: FDA budget brings a familiar tune
FDA commissioner Robert Califf. Photo illustration: Aïda Amer/Axios. Photo: Win McNamee/Getty Images
The first six-bill minibus puts the FDA in a familiar position: Having to do more with roughly the same resources, Victoria reports.
Why it matters: The agency's $6.72 billion FY2024 allocation does bring some budget certainty after multiple stopgap measures.
- But regulators under commissioner Robert Califf have more priorities, including first-time regulation of cosmetics, enhanced food and medical product safety and efforts to reduce animal testing.
By the numbers: The spending package will deliver a 2.4% funding bump, over the $6.56 billion the agency received in FY2023.
- But it's well south of the Biden administration's budget request of $7.2 billion.
- The funding will consist of $3.52 billion in discretionary spending and $3.2 billion in industry user fees that fund product evaluations and other functions.
- Last year, the agency got slightly more in discretionary spending and less from user fees.
- Virtually every department within the FDA received an increase in funding compared to FY2023.
What's inside: There are some noteworthy nuggets tucked into the spending package.
- The FDA is getting $7 million to regulate cosmetic products and ingredients — a new task stemming from a 2022 law that Congress passed. It's an open question whether that's enough to assess records and wield mandatory recall authority over products.
- Senate Democrats noted that the agency will get $50 million to continue implementing the 21st Century Cures Act and $1.5 million to reduce animal testing through alternative methods.
- House Republicans also touted that the bill would provide no pay increases for employees for FY2024.
Biden's budget request called for increased funding for food safety and nutrition, enhanced medical product safety, public health programs to combat opioid use and for aspects of the Cancer Moonshot.
What they're saying: "In the balance of this fiscal year, FDA will face the challenges of absorbing mandatory pay increases and meeting various congressional priorities and public expectations," said Steven Grossman, executive director of the Alliance for a Stronger FDA.
- "Requiring FDA to do a lot more for the same funding is not a recipe for success."
What we're watching: Whether the minibus hits any snags on the House floor this week or sails through — and what Biden's next budget holds for the agency when it comes out on Monday.
2. Bill of the week: Essential hospitals
Illustration: Gabriella Turrisi/Axios
Reps. Lori Trahan and David Valadao want to create an "essential health system" designation in federal law that would make it easier for safety net hospitals to obtain federal funding, Axios' Adriel Bettelheim reports.
Why it matters: The Reinforcing Essential Health Systems for Communities Act seeks to create a standard definition of an essential hospital at a time when many facilities claim to be safety nets.
- States already have discretion to steer extra funding to hospitals that treat more uninsured and low-income patients. But criteria vary, and funds don't always reach the right facilities.
How it works: A hospital would get the new designation either if it meets Medicaid's disproportionate share hospital requirements, if at least 35% of patients are Medicaid or low-income Medicare, or if its Medicare uncompensated care payment factor is 0.0005 or more.
- Trahan and Valadao said the designation would cover more than 1,000 facilities nationwide.
- America's Essential Hospitals, which backs the bill, said there is precedent for such special designations, pointing to critical access, sole community and other facilities that serve specific populations and regions.
What we're watching: The legislation comes at a time when many hospitals are seeing improved margins and shaking off the pandemic's financial effects — and as Congress is reevaluating how facilities are paid by federal health programs.
3. Bills to watch
Illustration: Natalie Peeples/Axios
A set of non-controversial health bills are on the House suspension calendar today. The measures include:
1. The Preventing Maternal Deaths Reauthorization Act of 2023 to extend funding for states to address disparities in maternal health.
2. The Medicaid Primary Care Improvement Act to give states discretion to expand access to primary care services for a flat monthly fee.
3. The Action for Dental Health Act of 2023 to give states grants to address shortages of dental health workers.
4. The Gabriella Miller Kids First Research Act 2.0 reauthorizing a pediatric disease research initiative within NIH.
✅ Thank you for reading Axios Pro Policy, and thanks to editors Adriel Bettelheim and David Nather and senior copy editor Bryan McBournie.
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