To ensure national uniformity with respect to certain requirements relating to preterm infant formula, and for other purposes.
Impact
If enacted, HB2300 would temporarily preempt state regulations relating to preterm infant formula, establishing a federal standard for its manufacture and safety. This preemption is framed to last for two years following the bill's enactment and is intended to prevent a scenario where different states could impose varying requirements, potentially complicating compliance for manufacturers. The bill recognizes exceptions for civil and criminal actions based on willful misconduct, ensuring that manufacturers can still be held accountable for severe negligence that leads to harm.
Summary
House Bill 2300, introduced in March 2025, is aimed at establishing national uniformity regarding the regulations surrounding preterm infant formula. The bill mandates a study conducted by the Secretary of Health and Human Services to evaluate the current availability and regulation of preterm infant formula in the United States. This study will review existing federal and state laws, including the design, manufacturing, and safety aspects of preterm infant formula, and it may result in recommendations for requiring premarket approval from the Food and Drug Administration (FDA).
Contention
One point of contention surrounding HB2300 is the balance between federal oversight and state control over local safety regulations. Proponents argue that the national uniformity will enhance safety and streamline the regulatory process, facilitating better access to safe preterm infant formulas across the country. Conversely, critics may raise concerns about overreaching federal authority, suggesting that local needs and conditions could be overlooked in favor of a one-size-fits-all approach to regulation that might not adequately address specific community concerns.
Pharmacy benefit managers and health carriers required to include lower-cost drugs in their formularies, and formulary structure and formulary tiering for each health plan required to give preference to the drug with the lowest out-of-pocket cost to the patient.
To amend title 23, United States Code, with respect to the amounts States are guaranteed under the highway apportionment formula, and for other purposes.
Pharmacy benefit managers and health carriers inclusion of lower-cost drugs in formularies requirement provision and lowest out-of-pocket-cost drug to patient formulary tiering preference provision