Animals in Research
December 31, 2024
Queenie's Law Sparks Debate Over Animal Research and Innovation in Michigan
Sen. Wojno introduced “Queenie’s Law,” Senate Bill 1019, to prohibit painful animal experiments.. The bill, a companion to legislation introduced in 2023 by Rep. Matt Koleszar (HB 4849) is a response to long- running, controversial dog studies conducted at Wayne State University.
MichBio provided written testimony in opposition to the proposed legislation. After a substitution during the Committee hearing, the proposed legislation would now only forbid public institutions from research that could injure, distress or kill dogs, no longer including cats or experiments done by private facilities in the state.
While the scope of the proposed ban shrunk, advocates say the bill will still do what it originally intended to: end painful and deadly experiments on dogs at public universities in the state.
MichBio, the Animal Health Institute, several private bioscience companies in Michigan, and public research institutions, argued that the bill would have unintended consequences relating to future research that could benefit humans and animals and that it would portray the state of Michigan as cultivating an anti-life science agenda and result in detrimental impacts to biomedical innovation and economy.
The bill from Rep. Koleszar also advanced out of the House Agriculture Committee by a 8-5 party- line vote, but was not considered by the full House during the lame duck.
In the end, both SB 1019 and HB 4849 died this legislative session due to inaction on the part of the House.
RECENT ARTICLES
Recent changes to Michigan's consumer protection laws have sparked debate, and a coalition of Michigan industry groups have joined to oppose the removal of the regulatory compliance exemption under the Michigan Consumer Protection Act (MCPA) . This exemption previously shielded regulated industries from lawsuits under the MCPA, but a recent bill, SB 134 , would repeal it. MichBio and coalition partners believe that this could lead to increased litigation and costly lawsuits for businesses and submitted their concerns and opposition to the Senate Finance, Insurance & Consumer Protection Committee. This legislation is a response to the Michigan Supreme Court 1999 case decision in Smith v. Globe Life Insurance Company , which supposedly weakened the power of the Michigan Consumer Protection Act by exempting many industries, like pharmaceuticals, from liability, leaving residents ill-protected from scams and other deceptive activity. The MCPA currently does not apply to “[a] transaction or conduct specifically authorized under laws administered by a regulatory board or officer acting under statutory authority of this state or the United States.” In its Smith v. Glove Life Ins. Co. and Liss v. Lewiston-Richards, Inc. decisions, the Michigan Supreme Court (MSC) interpreted this to mean the following: if a person or company is licensed or approved to engage in a certain business or profession, and the transaction at issue falls within the scope of that license, that conduct falls outside the MPCA. While these rulings do not give a complete exemption to regulated industries from the MCPA (i.e., if the person or business is operating outside the scope of the occupation or profession, there could be an MCPA claim), they do provide protections. Attorney General Nessel, who testified in support of the legislation in the prior session , launched an investigation into insulin manufacturer Eli Lilly and asked the Michigan Supreme Court to reconsider the two previous MSC rulings that hinder the Department’s ability to take action against drug manufacturers and other regulated/licensed entities under the MCPA. Under the 1999 and 2007 decisions, Nessel is unable to even begin an investigation into Eli Lilly because it is regulated by both the Federal Drug Administration and the Michigan Board of Pharmacy, even though neither have authority over pricing. The Court heard oral arguments in that matter earlier this year .
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.
