Michigan’s legislature is considering two bills, SB 94 and SB 95 related to the federal 340B Drug Pricing Program and both bills are expected to be deliberated by the House Health Policy Committee in due course. These bills, passed by the Michigan Senate, aim to prohibit drug manufacturers from restricting hospitals' access to discounted drugs under 340B. The 340B program was originally intended to help low-income and uninsured patients access affordable medications by requiring drug manufacturers to provide discounts to safety-net providers. However, misuse and abuse of this well-intentioned but ballooning program is driving up costs for patients, taxpayers, employers, and everyone who pays for healthcare. The 340B program enables participating hospitals to purchase medications at significant discounts and sell them to plan sponsors at the prevailing rate, a “buy low, sell high” scheme that results in profits at the expense of working families. There is no guarantee that 340B profits are passed to vulnerable patients in local communities, while raising prices due to incentives for steep markups on medications, lost rebates, health system consolidation, and incentives to prescribe higher-cost drugs and fewer biosimilars. MichBio spent time alongside representatives from member companies and our national organization, BIO, educating key legislators about 340B and specifically raised concerns about the potential impact of 340B programs on drug pricing and innovation. We and our partners maintain that any changes to the 340B program should be comprehensive and address systemic issues, such as transparency, diversion, and duplicate discounts, ideally at the federal level. MichBio continues to work to ensure that any changes to the program do not negatively affect patients, providers, and the industry as a whole.

A citizen petition has been filed objecting to the FDA's recent call for alternatives to animal testing, arguing that it could lead to reliance on unvalidated methods and pose risks to human subjects. The petition suggests that the FDA's move to embrace alternatives may not be fully vetted and could jeopardize human safety. Moreover, it calls on the FDA to amend its regulations, publish a guidance document on non-animal methods, and incorporate encouragement for their use in existing and future guidance documents. As background, on April 10, 2025, the FDA announced its intent to phase out the use of animal testing in the development of certain drugs and biologics. To help bring this “paradigm shift in drug evaluation” to fruition as outlined in a roadmap , FDA is offering pharmaceutical manufacturers incentives such as faster approval times and reduced testing requirements if they leverage emerging technologies that the agency believes hold the promise of cheaper, safer, and more ethical drug development processes. The FDA’s sights are currently set on obviating the need for animal testing specifically in monoclonal antibody trials. However, the agency emphasized in the announcement its desire to expand its efforts to all future applicable use cases. Opponents of animal testing have celebrated the FDA shift as a significant win. However, the fact is that such changes have been in the works for decades, as many research efforts in both the public and private sectors have focused on developing alternative testing technologies and models. The petition asks that FDA stay its implementation of the April 10 policy, saying it should not be put into practice without a public comment period and an independent expert review of the proposed alternatives to animal testing. Without public comment, the organization says the change is a rulemaking that doesn’t follow the requirements of the Administrative Procedure Act. Notwithstanding the petition, the FDA plans to host a public workshop later 2025 to discuss the roadmap and aims to launch the pilot program allowing select monoclonal antibody developers to use a primarily non-animal-based testing strategy.