September 10, 2026

Today, September 10, several Assembly committees are meeting for the first time since returning following the summer — and a handful of bills of interest are being considered.

The Assembly Community Development & Women’s Affairs Committee, chaired by Assemblywoman Tennille McCoy, met at 10AM with an agenda that included two bills focused on women’s health:

• A2723 (Katz/Venezia) - Requires certain health care facilities to offer lactation counseling and consultations to persons who have given birth.
• A4704 (Speight) - Requires employer to provide certain accommodations to employee who is breast feeding.

The Assembly Regulated Professions Committee, chaired by Assemblyman Dan Hutchison, is meeting at 2PM and will also consider a few bills focused on women’s health:

• A2181 (Speight/Haider/McCoy) - Establishes requirements to evaluate certain people who are pregnant and who have given birth for endometriosis.
• A2188 (Speight/Reynolds-Jackson/Fantasia) - Establishes requirements to evaluate certain people who are pregnant and who have given birth for preeclampsia.

Next week, Group C & D Committees, which include Health Infrastructure, Judiciary, Aging & Human Services, Environment and Science/Innovation/Technology Committees will potentially meet on September 14.

At the end of August, Senate President Nick Scutari (D, LD22) sent a letter to Governor Sherrill conveying that his office has heard concerns that the New Jersey Department of Labor’s “ABC” test regulations remain overly broad. He is now asking for a delay until July 1, 2027 to allow for a comprehensive review between the Legislature, workers, unions and business community. “ABC” is an initialism describing three criteria of the test.

In short, the State’s ABC test determines whether a worker is an independent contractor or employee. If a business fails to demonstrate one of the three criteria, it fails the “ABC” test.

This week, the New Jersey Business and Industry Association (NJBIA) launched a campaign to urge the Governor to pause implementation following codification by the Department of Labor on May 5. NJBIA notes that the new test presumes a worker is an employee, and businesses are required to prove all three criteria of the test to establish whether a worker is an independent contractor.

To read Senate President Scutari’s message to the Governor, click here.

For more information from NJBIA on the status of the ABC Test, including information to submit a request to delay implementation of the ABC Test, click here.

For the Department of Labor’s explanation of the ABC Test, click here.

Last month, IQVIA released a white paper entitled “The Cost of 340B to States in 2025.” The study estimates the cost of the program’s rebate displacement to commercial health plans, employers, states and the federal government, building upon prior research that the organization had conducted — broadening the scope of the work to include non-group plans and Managed Medicaid plans.

Top-line findings include that commercial-market lost rebates more than doubled from 2023 to 2025, “reaching $14.5 billion, while Managed Medicaid rebate displacement added approximately $4.2 billion in combined state and federal costs, for a total estimated cost of $18.7 billion.” Further, the report indicates that the program’s financial effects extend beyond covered entities and affect employers, enrollees, state Medicaid programs and the federal government.

Interestingly, IQVIA found that 340B utilization rates vary by more than tenfold, from a high of 45% in Vermont to the lowest of 4% in New Jersey, as demonstrated in Figure 3.1. Further, “per-beneficiary lost rebates closely track 340B utilization, ranging from $25 in New Jersey to $260 in Vermont.

In short, the report found that the significant growth in the 340B program is associated with “substantial and geographically uneven increases in lost rebates.”

To read the full IQVIA report, click here.

At the beginning of August, the FDA announced actions intended to accelerate and modernize clinical research across drug development, from the Investigational New Drug (IND) phase to late-stage pivotal trials.

To read the FDA’s announcement of this pilot program, click here.

At the end of August, the Biotechnology Innovation Organization (BIO) posted comments on the pilot program, acknowledging both the potential benefits and potential risks that the Organization perceives. In particular, BIO highlighted the concept of “rolling reviews,” enabling sponsors to provide individual modules of IND applications instead of waiting until all modules of an application are complete.

However, the pilot’s requirement that applicants partner with a Qualified Research Institution (QRI) introduces a “third-party layer” to the process with ambiguous benefits. QRIs are defined as academic medical centers, contract research organizations and other institutions with deep subject matter area expertise. The stated goal of this component is to ensure that applicants provide “complete data, meet FDA standards and provide submissions with recommendations from external experts.”

BIO notes that this proposal may result in an additional layer of review with unclear ultimate benefit.

To read BIO’s full post on this pilot program, click here.

To read BIO’s formal submitted comment to the FDA, click here.

Next week on September 16, the FDA will be holding a public meeting to discuss proposed recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA) for fiscal years 2028 through 2032. While the meeting will be held at the FDA White Oak campus from 9AM—2PM, there will be a virtual option.

For more information and registration, click here.

Additionally, BIO has provided an explanation of their goals and approaches during this reauthorization. To explore their resources, click here.

In late August, Congressman Bob Latta (R, OH-5) and Congresswoman Debbie Dingel (D, MI-6) announced the introduction of the Biomanufacturing Excellence, Domestic Resilience, Output, and Competitive Know-how Act — or the BEDROCK Act. Among the goals of the act are to designate a senior Department of Commerce official to lead efforts focused on U.S. biomanufacturing competitiveness, assess biomanufacturing supply-chain inputs and develop an action plan and federal commercialization processes.

Given the findings and recommendations by the National Security Commission on Emerging Biotechnology (NSCEB), with whom BioNJ collaborated during the preparation of their final report, and the interest expressed by a variety of lawmakers across the federal government, BioNJ is pleased to see ongoing intent and action to support the U.S. biopharmaceutical sector.

To read a pressor on the BEDROCK Act, click here.

To read the NSCEB’s final report, click here.

Earlier this month, the NIH and Defense Officials announced an interagency agreement for “research and development of therapeutics, diagnostics and personal protective equipment against chemical, biological, radiological and nuclear (CBRN).”

The agreement is officially between Robert Kadlec, the Assistant Secretary of War for Nuclear Deterrence, Chemical and Biological Defense Policy and Programs and Jay Bhattacharya, Director of the NIH. Prior to serving as Assistant Secretary for War, Robert Kadlec served as Assistant Secretary of Health & Human Services for Preparedness and Response at the Administration for Strategic Preparedness and Response (ASPR).

According to Nature, the NIH is currently identifying projects it would transfer to the Pentagon with the goal of completing that transfer by the end of September — and a senior NIH official conveyed that this new arrangement is “…trying to get research that’s more Department of War-related back to the Department of War,” citing concerns that the public perceives NIH funding allocated to biodefence as being used to develop bioweapons.

Senior Democratic members serving on the Appropriations Committee have conveyed concerns that this arrangement amounts to a diversion of billions of dollars from the NIH to supplement the Pentagon’s budget, including Ranking Member Rosa DeLauro (D, CT-3).

To read the full agreement between the NIH & Pentagon, click here.

To read coverage of this agreement in Nature, click here.

To read concerns published by House Appropriations Committee Ranking Member DeLauro, click here.

Last week, Minority Leader Hakeem Jeffries (D, NY-8) noted that two of the four policy priorities that the democratic caucus is prioritizing if they are to win a majority in the House will be focused on health care. In an interview with NBC, Leader Jeffries conveyed an intention to extend the Affordable Care Act tax credits and to address changes that were made to the Medicaid program. Additional reporting indicates an intention to lower the age for Medicare eligibility and adding dental, vision and hearing benefits.

To read Leader Jeffries’ interview in NBC, click here.

For broader coverage and commentary in STAT, 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 2026. You can help to ensure that BioNJ continues to deliver our message of improved Patient access and enhanced innovation through a Public Policy Support Series Sponsorship.

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