Rare Disease Advisory Council

Legislation (HB 4167) to establish a Rare Disease Advisory Council (RDAC) in Michigan were progressing nicely through the summer following overwhelming bipartisan passage by the full House. A RDAC would empower rare disease patients as partners in helping to shape policy development relevant to the unmet needs, common struggles, and concerns on equitable, quality, and…

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Regulation of Dogs and Cats in Research

SB 148 and SB 149, sponsored by Sen. Polehanki and Sen. Hertel, respectively, sought to regulate the use/disposition of animals in research including mandatory reporting on numbers of animals owned, used, and released by research facilities, mandatory requirement for adoption of research animals post-use, and other restrictions and penalties. The legislation arose after an outcry…

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Legislation to Enact Prescription Drug Price Controls

SB 483, SB 484 and SB 485 were introduced in mid-September 2023 that would establish a new state board – a so-called Prescription Drug Affordability Board (PDAB) – that would determine how much pharmaceutical companies can charge for certain drugs by setting an “upper price limit”. According to PDAB supporters, such a body would lower…

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So Close on Reestablishing State R&D Tax Credit…

Early fall 2023 saw a package of bills introduced that would reestablish a state research & development R&D) tax credit in Michigan – HBs 5099, 5100, 5101 and 5102. Ever since Michigan moved from the Michigan Business Tax regime to the current Corporate Income Tax regime twelve years ago, Michigan taxpayers have not been afforded…

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Repeal of R&D Amortization

The America Innovation and R&D Competitiveness Act of 2023 or HB 2673 was reintroduced that would repeal current rules and allow a business to deduct of R&D costs in the tax year that they occur and thereby incentivize long-term investments in innovation. Such repeal has been a top policy priority for MichBio and the bio-industry generally…

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White House Announces New Efforts to Target Prescription Drug Prices

On December 7, the Biden Administration announced new efforts intended to lower prescription drug costs. While the announcement includes broader initiatives, one component would allow invoking March-In rights under the Bayh-Dole Act to license the patent rights of drugs to other biopharmaceutical manufacturers when the price of the drug is deemed to be too high. MichBio has grave…

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FTC, DOJ Finalize Merger Guidelines that Could Impede Healthcare Deals

The Federal Trade Commission (FTC) and Department of Justice (DOJ) released new merger guidelines that have implications for the life sciences industry. The new guidelines may give regulators more ammunition to go after vertical and cross-market M&A that has historically been more difficult to challenge. Private equity “roll-ups” of multiple companies may also face heightened scrutiny. The…

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Drug Price Transparency Bill Introduced

HB 4409, the “Drug Manufacturer Data Reporting Act” was introduced recently by Rep. Steckloff (D-MI-19), as an attempt to seek more transparency and control of drug prices. The bill would require biotech/pharma companies to provide information on a range of expenses including R&D, marketing, clinical development, whether and how much the company received in federal…

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Rare Disease Advisory Council – Take 2

Rep. Jason Morgan (D- MI-23) introduced HB 4167 late February, the latest attempt to establish a Rare Disease Advisory Council (RDAC) in Michigan. A RDAC would empower rare disease patients as partners in helping to shape policy development relevant to the unmet needs, common struggles, and concerns on equitable, quality, and affordable access to specialty…

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Bills To Help Early-Stage Innovators Access Working Capital

The House Financial Services Committee, in a marathon session late April, considered a package of 15 bills designed to relieve regulatory burdens and facilitate access to needed capital for biotech startups. Among them were the following: The Equal Opportunity for All Investors Act,which would create a certification exam to qualify as an accredited investor so more…

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