April 16, 2025

On April 10, the Assembly Financial Institutions & Insurance Committee met to consider a bill that will apply guardrails to step therapy practices associated with medications prescribed for serious mental illness and to hear testimony from invited guests focused upon the impact that pharmacy benefit managers (PBMs) have on the broader health insurance system and how they affect drug prices.

Two speakers were invited to speak: Professor Michael Carrier from Rutgers University Law School and Dr. Geoffrey Joyce, Director of Health Policy at the University of Southern California Schaeffer Center.

BioNJ is pleased to see the State Legislature continue to scrutinize the prime drivers of unaffordability and diminished access that Patients face due to the unproductive business practices of PBMs that fundamentally cause higher prices and reduced Patient access.

To read a press release on the hearing focused on PBMs from the Assembly Majority Office, click here.

A4838 (Pintor Marin/Park/Bagolie) — Requires prescription drug coverage for serious mental illness without prior authorization or utilization management, including step therapy.

Several legislators on the Committee emphasized the role that step therapy practices have played in the negative outcomes that constituents have shared with them and highlighted the importance of the relationship that Patients have with their clinicians. Legislators also highlighted that the decisions that both Patients and clinicians make together ought to determine what medication is best for the Patient.

BioNJ is pleased to see this bill continue to make progress and we hope to see it reach the Governor’s desk soon.

In addition, the following bill was introduced last week:

A5566 (Pintor Marin/Park) / S4374 (McKeon/Lagana) — Requires disclosure of third-party litigation funding agreements and establishes certain responsibilities for litigation funders.

BioNJ looks forward to supporting this legislation and hopes to see it make progress as the Legislature contemplates its provisions.

At the beginning of April, BioNJ joined our state BIO affiliate organizations across the country in visiting our congressional delegations. We were fortunate to be joined by a variety of our Member companies. Our group represented the full spectrum of the life sciences ecosystem — from small biotech companies to some of the largest biopharma companies in the world.

BioNJ's coalition was fortunate to meet with the majority of New Jersey’s congressional delegation. We are grateful for the receptivity that the legislators and their teams conveyed during our discussions of the challenges and opportunities that the ecosystem faces.

BioNJ is hopeful that several of our priorities will make progress, including, but not limited to:

• R&D Amortization/Section 174 fix
• SBIR Reauthorization
• Rare Pediatric Priority Review Voucher program reauthorization
• EPIC & ORPHAN Cures acts
• HELP Copays Act
• Prescription Information Modernization Act



We were pleased to see that Rep. Kean Jr. (R, NJ-7) signed on as a co-sponsor of the ORPHAN Cures Act soon after our visit and are grateful for all of the additional support that members of the New Jersey congressional delegation have provided in the past and continue to provide. We also thank all of the advocates who have conveyed how essential these policies are to enabling the life sciences sector to continue developing new therapeutics.

We look forward to continuing to work with New Jersey’s congressional delegation to ensure that both New Jersey — and the United States — continues to be the central nucleus of biomedical innovation worldwide.

A selection of photos with New Jersey’s congressional delegation:

Rep. Pou (D, NJ-9) with BioNJ Life Sciences delegation

Rep. Kean Jr. (R, NJ-7) with BioNJ Life Sciences delegation

Rep. Conaway (D, NJ-3) with BioNJ Life Sciences Delegation

The Bureau of Industry and Security, Office of Strategic Industries and Economic Security in the U.S. Department of Commerce recently released a notice requesting public comments on the 232 investigation that began on April 1. This investigation spans medications and active pharmaceutical ingredients (API) and other materials critical to manufacturing.

This is anticipated to be an introduction to future tariffs imposed on pharmaceuticals in the future. BioNJ has recently conveyed, and we will continue to convey, the impact that abrupt supply chain disruptions can have for the ability of Patients to have access to the medications that they need while ensuring that the U.S. continues to develop the most robust life sciences ecosystem in the world.

To read the request for public comment, click here.

To read coverage by STAT, click here.

On April 9, the Committee held a hearing with USTR Jamieson Greer. Interestingly, the hearing took place while significant changes to announced tariff policy was being made by the President, evolving from significant tariffs across the board to solely increasing tariffs on imports from China.

BioNJ is continuing to connect with Member companies to get a sense of how they are adapting to these changes in trade policy, as dynamic an environment as it is, and will look forward to conveying the implications for the ability of the life sciences sector to continue innovating in New Jersey and nationally.

To watch the hearing, click here.

A coalition of biotech companies conveyed their concerns regarding staff cuts of approximately 3,500 employees at the Food & Drug Administration (FDA) to U.S. Senator Cassidy (R, LA) who is the Chair of the Senate Health, Education, Labor and Pensions (HELP) Committee. Cuts to the FDA have included career employees. The Administration has also seen long-term leadership diminished as well, including the former Director of the Center for Biologics Evaluation and Research (CBER), Dr. Peter Marks who resigned as of April 5.

Debbie Hart, President & CEO of BioNJ, joined the diverse group of life sciences entities who signed on to the letter to Senator Cassidy.

To read the letter to Senator Cassidy, click here.

During our fly-in to D.C., BioNJ's coalition of life sciences companies conveyed similar concerns regarding the diminution of the FDA, as well as our hope for an effective and efficient FDA to ensure that medications are both safe and effective. We hope to see the FDA resourced to enable the Administration to accomplish its fundamental mission of ensuring Patients have access to the best possible treatments.

In addition, the National Organization for Rare Disorders (NORD) conveyed similar concerns regarding restructuring across the Department of Health and Human Services (HHS) more broadly. They emphasized the importance of the National Institutes of Health, FDA, Centers for Medicare and Medicaid Services (CMS) and the Health Resources and Services Administration (HRSA) to the rare disease community and conveyed their hope that the President’s administration will contemplate the unique challenges that the rare disease community faces.

To read coverage of the letter to Senator Cassidy in BioSpace, click here.

To read the letter from NORD, click here.

On April 3, the Chair of the House Committee on Oversight and Government Reform, James Comer (R, KY), announced a hearing entitled “Restoring Trust in FDA: Rooting Out Illicit Products.”

The hearing heard testimony from several witnesses, including representatives from the Reason Foundation, Mercatus Center, Partnership for Safe Medicine and an employee of the FDA.

To watch the hearing, click here.

After a last-minute halt to voting, the U.S. House adopted a framework for the government’s budget along party lines by a vote of 216-214, with two Republicans joining the Democratic party in opposing. While they have passed this framework, committees in both chambers will now begin writing the details of the budget with spending and tax cuts as the underlying goal — amounting to an intended $1.5 trillion cut in spending. However, military and both border security and immigration have the flexibility to increase spending. Both chambers will now begin turning resolutions into legislation.

BioNJ has conveyed, and will continue to convey, the importance of providing adequate funding to HHS to support everything from early-stage research to ensuring that Patients have access to the most advanced medications — while ensuring both are safe and effective.

Yesterday, the President signed an E.O that included suggested changes to components of the Inflation Reduction Act drug provisions. Among a variety of components, the order calls for ending the disparity in how the Inflation Reduction Act contemplates large- and small-molecule therapeutics. However, it fails to note that the best possible policy outcome, which would be to ensure that both are raised to the same period prior to being subject to price negotiation.

The E.O also includes provisions associated with generics and biosimilars, general healthcare transparency, and PBMs. Further components include aligning Medicare payment for certain prescription drugs with the cost by which hospitals acquire them, standardizing Medicare payments regardless of where Patients receive care, facilitating state-based drug importation programs, accelerating approval of generics/biosimilars/combination products and second-in-class brand name medications, and other provisions.

The E.O. also includes a call for a report on the reduction of anti-competitive behavior from pharmaceutical manufacturers. 

BioNJ looks forward to exploring this E.O. and hopes to continue finding opportunities to advocate for policies that will enable the life sciences ecosystem to continue to thrive.

For the Executive Order, click here.

For a post on the Executive Order by the White House, click here.

For coverage in Endpoints, 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.  

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