The recent national election and subsequent cabinet nominations have stirred wide-ranging discussions on healthcare priorities, regulatory changes, and the overall landscape for biotech and biopharma industries moving forward. With a new administration potentially reshaping priorities, MassBio and its members remain steadfast in advocating for policies that support innovation with a focus on research, development, and fact-based science as the foundation for innovation and patient care. Here’s what the MassBio community can expect:
1. Trump’s Stance on Healthcare and Other Administration Priorities
While President-elect Trump’s campaign emphasized economic and immigration issues, he largely sidestepped healthcare. However, he has signaled a commitment to reducing prescription drug and Medicare costs, which raises questions about how these goals may threaten Massachusetts’ relentless pursuit of innovative therapies for Americans and patients around the world.
MassBio maintains that the negotiation mechanisms within the Inflation Reduction Act (IRA) are stifling investment and invention and disrupting industry’s mission of bringing life-saving therapies to patients. We are hopeful that the incoming administration understands that imposing arbitrary price controls may undermine the economic dynamics essential for sustaining the advancements coming out of countless Massachusetts biotech companies. As we have done in the past, MassBio will continue to advocate to preserve innovation as price negotiations for IPAY 2027 begin next year.1
There is an expectation of bipartisan support for passage of the BIOSECURE Act, seeking to enhance national biosecurity by prohibiting federal contracts with certain overseas biotechnology companies. If passed, we will continue to advocate for significant funding to safeguard the U.S. industry and bolster its capabilities back home.2 Our hope is that the BIOSECURE Act could lead to legislation that boosts domestic onshoring of biomanufacturing, creating new jobs and reducing reliance on foreign supply chains.
Trump’s past focus on Pharmacy Benefit Manager (PBM) reform, a longstanding MassBio priority, may return. There is bipartisan support for PBM industry reforms in Congress, including a significant reform measure championed by Massachusetts’ own Congressman Jake Auchincloss. We are optimistic that we will see action on this front in the next year to rein in the power of industry middlemen to set prices and deny coverage.
We anticipate stronger Intellectual Property (IP) protection and abandoning of certain policies threatening patent protection, such as utilizing “march-in” rights to combat drug costs. Few sectors of the nation’s economy are as dependent on strong IP and patent protections as the biotechnology industry, and MassBio is hopeful the incoming administration recognizes how these protections enable the enormous investment necessary to bring treatments to patients.
Tax reform will likely be a day-one priority for the Trump administration and the Republican-led Congress and will continue to support legislation that leads to lower tax burdens overall on Massachusetts’ emerging biotechs. Capital is the lifeblood of the biotech industry, and MassBio contends that every dollar diverted away from R&D threatens to delay treatments to patients. Properly tailored tax incentives that support innovation – including improvements to the R&D and Orphan Drug Tax Credit, and further incentivizing domestic manufacturing and investment – are paramount for industry.
2. Impact on Biopharma
The previous Trump administration supported biopharma, notably during Operation Warp Speed, which oversaw nearly $18 billion in funding between March and October 2020. While there have been early indications that the Trump administration may still scrutinize “big tech”, this administration could foster an environment conducive to mergers and acquisitions (M&A) in the biotech industry, spurring continued company growth.
MassBio’s 2023 Massachusetts Biopharma Funding and Pipeline Report highlighted the critical importance of M&A in the biotech industry, showing 30 companies from Massachusetts made acquisitions totaling $8.92 billion in 2023 alone, which in part filled a gap left by a decrease in IPOs.3 MassBio will continue to promote the necessity of healthy biotech M&A and are hopeful the Federal Trade Commission will reduce hurdles to company mergers, encouraging continued strategic growth.
Nevertheless, MassBio has concerns and we are prepared to voice opposition toward other potential actions the administration may take. Confirmation hearings for nominees to the Department of Health and Human Services (HHS), Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), National Institutes of Health (NIH), and Centers for Medicare & Medicaid Services (CMS) will be essential, particularly for reforming NIH and maintaining scientific integrity in policy decisions.
President-elect Trump’s choice of Robert F. Kennedy Jr., who has expressed skepticism toward vaccines in the past, for HHS Secretary, in addition to actions taken toward the end of the last Trump administration loosening some FDA regulations, could signal potential changes to FDA oversight that may undermine public health and destabilize the regulatory environment that supports industry advancement.
MassBio undoubtedly supports the FDA’s mission to protect public health by ensuring the safety, efficacy, and security of drugs, biological products, and medical devices, and will continue to advocate for fact-based and science-driven policymaking to spur innovation and enhance patient access.
3. Impact on Massachusetts
Massachusetts is well-positioned to navigate this new environment, thanks to dedicated policymakers committed to life sciences advancement. Recent efforts by the Healey-Driscoll administration, along with House and Senate leadership, including final passage of the Life Sciences Initiative 3.0 at full capital funding over the next ten years, promise to bring a new wave of support toward infrastructure, early-stage investments, and tax incentives to secure Massachusetts’ leadership in 2025 and beyond.
These initiatives are vital to enhance job growth and cement the Commonwealth’s role as the global epicenter of biotechnology innovation and advancement. Beyond economic development, Massachusetts remains steadfast in its commitment to accessible reproductive and gender-affirming healthcare, reinforcing its progressive stance on inclusive health policies.
MassBio is positioning itself as a champion for scientific integrity, driving research-driven solutions that fuel industry growth while prioritizing public health and patient needs. As the political landscape evolves, we remain committed to advocating for policies that support ingenuity, protect scientific standards, and ensure access to life-saving therapies. By staying true to these principles, we can continue to foster a thriving biotech ecosystem that benefits patients, communities, the economy, and the Commonwealth alike.
[1] MassBio Comments RE: Medicare Drug Price Negotiation Program (7/2/24)
[2] MassBio Op-Ed in STAT: How to keep the BIOSECURE Act from hobbling U.S. biotech and pharma
[3] 2023 MassBio Biopharma Funding & Pipeline Report