Advocacy Outlook 2025: Early Days

Federal Expectations: White House to Dictate, Congress Likely to Follow Following the Republican trifecta gain of the White House and both houses of the U.S. Congress, business leaders would be wise to spend early 2025 assessing how politics will drive policy.   At this early stage, it’s still unclear what and how policy issues will…

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Attempts to Regulate Drug Pricing Fail During Legislative Chaos

In an attempt to address high, out-of-pocket drug prices, Democrats attempted to push through several piece of legislation that would have placed burdensome restrictions on drug manufacturers. One measure, HB 5350, would have required drug manufacturers to provide drug products to contract pharmacies participating in a 340B program without conditions or limitations, and thereby alter…

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Consumer Data Privacy Act Passed by Senate, but Dies in House

The Michigan Senate passed the Personal Data Privacy Act (SB 659) along party lines in lame duck session, moving Michigan a step closer to joining the growing ranks of states that have approved comprehensive privacy and data protection legislation. But the legislation didn’t get taken up by the House and died, meaning that the measure…

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Animals in Research

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…

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Rare Disease Advisory Council

The newly constituted Michigan Rare Disease Advisory Council (MI RDAC) met in early October 2024 and began its mandate as an advisory body that provides Michigan’s rare disease community with a stronger voice in state government. The agenda included introductions of current panel members, an overview of pending legislation to enact an RDAC by statute,…

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A Huge Win for Michigan’s Innovation Economy – R&D Tax Credit Reestablished

In a milestone for Michigan’s innovation economy, the legislature passed a long-awaited and long-fought Research & Development (R&D) Tax Credit legislation – fifteen years in the making! It was a protracted, and at times frustrating, journey for MichBio in its advocacy to reestablish an economic development incentive specifically aimed at R&D in Michigan. We watched…

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Ensuring Patient Access to Critical Breakthrough Products

This bipartisan legislation would enable millions of patients to receive quicker access to life- changing medical innovations. The legislation is designed to expedite the Medicare coverage determination process of breakthrough medical technologies for patients. Although the House of Representatives generated some momentum on related legislation, H.R. 1691, a Senate companion bill, S. 5349, the “Ensuring…

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CMS Finalizes Accelerated Approval Pathway for Devices

The Transitional Coverage for Emerging Technologies (TCET) pathway was finalized by the Centers for Medicare & Medicaid Services (CMS). It aims to provide Medicare beneficiaries with more timely access to new medical technologies. It also seeks to improve the quality of life for people with Medicare and encourage innovation. Medical devices must meet the following…

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Biosecure act Fails to be Enacted

The Biosecure Act missed its expected ride through the U.S. Congress when the Senate failed to include it in the National Defense Authorization Act. However, it may not be the end of the road for the bill that would prohibit direct or indirect U.S. government contracts with listed Chinese “biotechnology companies of concern.” The U.S.…

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