May 15, 2025

Last week, Governor Murphy signed a bill into law that will implement guidelines on step therapy for the State Health Benefits Program, School Employees Health Benefits Program and the State’s Medicaid program. A1825, sponsored by Assemblyman Verrelli and Senators McKnight and Bramnick, will diminish the obstacles that separate Patients from the therapeutics and care that they and their physicians determine are best for them. BioNJ appreciates the willingness of the Governor and Legislature to devise Patient-focused legislation and we look forward to continued progress.

In addition, the “Packaging and Paper Product Stewardship Act” made progress through the Assembly Environment, Natural Resources and Solid Waste Committee (AEN) last week. A5009, sponsored by Assemblymembers Collazos-Gill, Hall and Kennedy, moved through the Committee by a vote of 5-2 along party lines.

The last action on the bill was in the Senate, when it was amended in the Senate Environment and Energy Committee in February. AEN amended the bill to match the Senate counterpart — which ensures that the treatments and therapeutics that the life sciences sector manufactures are excluded. The bill is now referred to the Assembly Science, innovation and Technology Committee.

BioNJ is grateful to the bill sponsors for their receptivity to ensure that the bill fundamentally accomplishes the sponsors’ goals while avoiding any impediment to the ability for Patients to access the medications and treatments that they need.

The Legislature will continue to contemplate the State budget over the next few weeks following the revenue updates from the State Treasurer and the Office of Legislative Services yesterday and today — and will work to pass the State’s budget by the end of June.

In addition, both the democratic and republican candidates have had debates ahead of the June primary elections, with the last day to register to vote being May 20, the deadline to apply for a mail-in ballot by mail being June 3, and the deadline to apply for a mail-in ballot in person being June 9 by 3:00 PM.

The primary election will be held on June 10.

To watch the democratic debate, click here.

To watch the republican debate, click here.

Finally, the State’s Office of Legislative Services (OLS) and the State Treasurer provided revenue updates ahead of the FY 2026 budget. OLS noted an upward adjustment of “merely $97.l0 million or 0.1%” for FY 2025 and FY 2026.

The State Treasurer’s testimony included the following overall revenue forecasts:

“For FY2025, we are increasing our total forecast by $388.5 million above our previous estimate back in February. We now project $55.3 billion for the current fiscal year, driven by higher collections from the Gross Income Tax (GIT) and the Pass-Through Business Alternative Income Tax (PTBAIT), but also partially offset by lower Corporation Business Tax (CBT) collections. These three tax revenues account for the bulk of the overall forecasting revisions.

For next year, FY2026, we are increasing the aggregate forecast by a total of $323.2 million to $57.1 billion.”

Testimony noted significant budgetary uncertainty as a function of the status of federal funds, noting a need to be as prepared as possible for substantial cuts.

To watch the revenue update from OLS, click here.

To watch the revenue update from the Treasurer, click here.

As a part of the negotiations for a reconciliation package, reporting has indicated that Congress is contemplating the inclusion of policies that would require life sciences companies to pay significantly higher rebates in Medicaid — either through an increase in the base rebate or by requiring them to pay the lowest global rate in Medicaid via foreign reference pricing. This policy, typically referred to as “most favored nation” (MFN) pricing, would have a catastrophic effect on our sector, and BioNJ has conveyed this reality to our congressional delegation and also signed on to a letter from the Council of State Bioscience Associations (CSBA) addressed to the majority and minority leaders in the U.S. Senate and House.

To read the letter sent by CSBA to congressional leadership, click here.

BioNJ is hopeful that all policymakers contemplate the ramifications that the implementation of this policy would have at a time when other nations are aggressively pursuing the expansion and domination of the life sciences sector. We are also hopeful that they will prioritize the true drivers of unaffordability across healthcare and pursue policies that will truly reduce the costs that Patients face without imperiling the ability of the life sciences sector to continue innovating.

In response to the E.O., Debbie Hart, President & CEO of BioNJ, released the following statement:

To read the full executive order, click here.

To read coverage of the EO and BioNJ comments in BINJE, click here.

Last week, Ian McLaughlin, VP of Government Affairs at BioNJ, joined a coalition of representatives from biopharma companies and other partner organizations in meetings with policymakers in Washington, D.C. focused on the unique role that mergers & acquisitions (M&A) plays in the life sciences.

In meetings with members of both the New Jersey and Maryland congressional delegations, we conveyed the symbiotic relationship that small biotechnology companies have with the large biopharma companies over the course of the life cycle of novel therapeutics. We conveyed that this relationship is rather unique to the life sciences sector, and that the imposition of significant friction to inhibit the relationships that are critical between companies in the sector are significant obstacles that prevent a molecule from becoming a medicine.

Sample of meetings of PULSE Coalition meetings with members of multiple state congressional delegations:

Kelly Schulz, Maryland Tech Council; Rep. Johnny Olszewski (D-MD); Ian McLaughlin, BioNJ;

Steve Issenman, HINJ

Steve Issenman, HINJ; Rep. LaMonica McIver (D-NJ); Ian McLaughlin, BioNJ

To read coverage of these meetings via the Partnership for the US Life Science Ecosystem (PULSE), click here.

Last week, the Patent Eligibility Restoration Act (PERA) was reintroduced. The bicameral legislation would be helpful in establishing greater certainty and protection for intellectual property by clarifying which inventions are eligible for patent protection. Currently, innovators in the life sciences face unpredictability regarding what precisely qualifies for patentability — and, as bill sponsor Senator Tillis (R-NC) conveys:

“This bipartisan, bicameral legislation maintains the existing statutory categories of eligible subject matter, which have worked well for over two centuries, while addressing inappropriate judicially created eligibility limitations by creating clear rules for what is eligible.”

The bill will clarify which inventions are viable for patentability in Section 101 of the Patent Act, and BioNJ will continue conveying the virtues of these clarifications to our State’s congressional delegation.

To read a statement from Sen. Tillis, click here.

Last week, it was announced that Dr. Vinay Prasad, a professor at the University of California, will succeed longtime Director Dr. Peter Marks at the Center for Biologics Evaluation and Research (CBER) at the Food & Drug Administration (FDA) who departed recently.

For coverage of this appointment by STAT, click here.

On June 4 & 5, the Bayh-Dole Coalition will host its third-annual American Innovator Award Ceremony and “Faces of American Innovation” Capitol Hill briefing. Five researchers, entrepreneurs and administrators are celebrating the Bayh-Dole Act’s 45th anniversary of its signing and will meet with members of Congress.

To RSVP for the Ceremony and Briefing, click here.

BioNJ is the voice of New Jersey’s life sciences sector in Trenton and Washington. BioNJ’s Public Policy Support Series sponsorship opportunities are now available for 2025. Help ensure BioNJ continues to deliver our message of improved Patient access and enhanced innovation through a Public Policy Support Series Sponsorship.  

Click here for more information.

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