Michigan Business Beat | Mackinac Policy Conference 2024 - Dr. Stephen Rapundalo - #MPC24 (2024)

Join us at the pinnacle event forMichigan’s medtech community, Monday, Sept. 23, 2024. Dive into the latest medical device technologies, regulations, and market trends, and discover what makesMichigan a hub for medical innovation. Hear from the state’s top thought leaders as they share their insights on current topics.

Network with a diverse group of professionals, including medtech sector experts, academic researchers, healthcare providers, suppliers, contract manufacturers, investors, business leaders, and government officials. Don’t miss this unique opportunity to connect, learn, and collaborate with innovators across all growth stages.

More Information to come!

MichBio,Michigan’sbiosciences association, announced at the 2024 Mackinac Policy Conference that it will update theMichiganBio-Industry Roadmap for Success. Originally released in 2016, the updated strategic plan aims to positionMichigan as a global leader inbiosciences. The new roadmap will focus on expanding sectors like pharmaceuticals, medical technologies, and agriculturalbiotechnology while improving innovation, business climate, and talent development. Outreach efforts will include a statewide listening tour and stakeholder engagement to refine strategies and identify growth opportunities. Read the full press release on our website for more details.

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The U.S. Department of Labor (DOL) has implemented a new rule that changes how workers are classified under the Fair Labor Standards Act (FLSA). Effective March 11, 2024, this rule aims to ensure more workers receive proper classification and thus, appropriate wages and protections.

Key highlights from the new rule include the adoption of a six-factor "totality-of-the-circ*mstances analysis" to determine worker status. This shift may result in fewer workers being classified as independent contractors.

Misclassifying employees can lead to significant penalties, including back pay for unpaid overtime, double damages, and additional legal fees. Employers are urged to reassess their worker classifications and contracts to comply with the new regulations.

For a detailed analysis, read the full article by Melvin J. Muskovitz, Esq., counsel at Dykema on our website.

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MichBio welcomesJamie Krajny (left) as the newDirector of Marketing and Industry Engagement! With 18 years of experience in marketing, communications, and public relations, Jamie has a proven track record of driving industry engagement through innovative strategies and compelling storytelling.

Her background includes notable roles at two statewide member-based associations inMichigan, where she showcased her commitment to fostering community participation and amplifying organizational missions. She can be reached atjamie@michbio.org

MichBio is seeking committed individuals for two non-voting Officer roles: Secretary and Treasurer. This is a unique chance to drive our mission forward and shapeMichBio's future. Both roles require attendance at quarterly Board meetings and relevant Committee meetings, typically held virtually. Terms last one calendar year with no re-appointment limits.

Interested? Contactstephen@michbio.orgwith your background and non-profit experience.Feel free to share this opportunity with your network!

Revised legislation that would restrict US organizations from contracting with some Chinesebiotech providers has been passed by a House of Representatives committee.

First introduced in January, the original bipartisanBIOSECURE Actsingled out various Chinesebiotech companies, including genomics specialist BGI Group and its subsidiary companies MGI and Complete Genomics, as well as contract development and manufacturing organization WuXi Apptec, describing them as “foreign adversarybiotech companies.” The wording of theBIOSECURE Act claims that China is seeking to dominatebiotechnology as an industry of the future.

The House has backed anupdated versionof the bill that includes a later deadline of January 31, 2032, for US companies to cut their ties with companies cited in the legislation, which include WuXi AppTec, BGI Group, MGI/Complete Genomics, and now WuXiBiologics, which was added in the latest draft. It would prohibit the purchase of equipment or contracting of services from the companies.

According toBIOCEO John Crowley, the newBIOSECURE legislation “highlights a key vulnerability in our global supply chain and provides a reasonable timeframe for companies to decouple their reliance on China-basedbiomanufacturing. It ensures during this transition that importantbiomedical research will not be slowed and that patients will have unimpeded access to life-saving medicines.”

The context here isthat the results from aBIOsurvey of 124biopharma companiesfound that 79% have at least one contract or product with a China-based or China-owned CDMO/CMO, and they’ll need up to eight years to switch manufacturing partners.

Life sciences companies doing business with WuXi AppTec, BGI Group, MGI, or Complete Genomics (entities specifically named in the legislation) as well as other potentialbiotechnology companies of concern (e.g., companies with ties to the governments of China, Russia, North Korea, or Iran), will want to monitor the developments of this legislation and assess in advance how to mitigate its potential effects.

Stay tuned…depending on the legislation’s final form and implementation, a range of companies could be forced to choose between forgoing relationships withbiotechnology companies of concern or forgoing relationships with the federal government.

MichBio helped host one ofBIO’s (Biotechnology Innovation Organization) regional Town Halls as part of their Big Bold Idea 2025 Initiative. Held at the offices of Ann Arbor-based ONL Therapeutics (a member of bothBIOandMichBio), some twenty emerging company and industry leaders from acrossMichigan gathered to share perspectives and solutions to the biggest challenges facingbiotech and how to shape the future of the ecosystem.

Topics revolved around FDA and regulatory issues (real-world evidence, clinical trial innovation, digital health), capital formation and investment, access to medicines and payment models, intellectual property protection, and workforce development.

Feedback from such Town Halls will be used to create and promote a new, effective, forward-facing policy and advocacy platform in 2025.

1. The impact that changes in the R&D Expensing Rules(i.e., IRC Section 174) are having onMichigan businesses and the importance of changing back to the previous rule allowing 100% expensing in one year versus the current requirement to expense over 5 years.
2. Addressing the disparity in how small and large molecule therapeutics are treated by the price-focused provisions of the Inflation Reduction Act (IRA) and how the law currently disincentivizes the pursuit of secondary indications for orphan drugs.
3. How invoking march-in rights would imperil U.S. innovation and development of life-saving products (see separate section on Bayh-Dole).

The Bayh-Dole Coalition, of whichMichBio is a member, released a video to articulate the importance and efficacy of the Bayh-Dole Act. The video includes interviews with a variety of directors of technology transfer at leadingbiomedical research universities, including Johns Hopkins University, Washington University in St. Louis, Emory University, Duke University, Wake Forest University, Dartmouth College, Florida State University as well as the Association of American Universities.

The Biden Administration and others have been advocating for invoking march-in rights under the Bayh-Dole Act as a means to control the purported high cost of pharmaceuticals.

To view and share this video,click here.

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The FDA publishedfinal guidancethat clarifies how companies can determine when their activities are remanufacturing, as opposed to servicing or repairs, and affirms remanufacturers may face agency inspections and other requirements imposed on device makers. A new section was added that lays out the regulatory requirements that apply to remanufacturers, aimed at entities less experienced with medical device regulation, including those who may consider themselves service providers.

Nevertheless, questions remain. For example, servicers will have to determine themselves whether their activities constitute remanufacturing. This might be difficult as they don’t typically have access to original equipment makers’ (OEMs) confidential data. Additionally, since device servicers are not required to register with the FDA, they will not be subject to routine inspections. Without access to OEMs’ confidential information about devices’ design, servicers may not be able to accurately self-assess whether they are conducting remanufacturing. Thus, it’s unclear how effective the agency’s oversight will truly be.

The Centers for Medicare & Medicaid Services (CMS) announced, following input on the proposed rule for the Medicaid Drug Rebate Program (MDRP), that it will not be finalizing the proposal associated with stacking. The proposed MDRP rule would have required manufactures to “stack” all price concessions across the entire supply chain for a single unit of a medication, potentially increasing Medicaid rebate liabilities with inevitable broader ramifications for the 340B program and commercial markets.

To read the CMS statement,click here.The proposed change would likely have resulted in significantly increased rebate liability for pharmaceutical manufacturers.

While CMS has decided at this time not to finalize the proposed best price stacking rule, that does not mean it will not do so in the future – it plans to work with pharmaceutical manufacturers to collect additional information related to best price stacking methodologies to better understand and inform future rulemaking.