February 19, 2025

As we approach the Governor’s Budget Address on February 25, there are a few updates across the State Legislature that are worth noting.

Last week, the BioNJ Public Policy Committee met with Assemblywoman Carol Murphy (D, LD7) to discuss her priorities as the new Chair of the Assembly Health Committee. Topics included copay accumulators, mental health, Patient access, step therapy and women’s health. BioNJ looks forward to supporting Chairwoman Murphy’s efforts to ensure Patients have access to the medications they need.

S3398 (Smith/Moriarty) was reported by the Senate Environment and Energy Committee last week. The “Packaging and Paper Product Stewardship Act” would impose a set of requirements on all producers of packaging and paper products. The bill now incorporates language that will ensure that the life sciences industry will continue to be able to produce medications and medical devices as they have in the past without being subject to the provisions of the bill.

Other bills worth noting:

• S2886 (Greenstein/Turner) — Requires pharmacies to provide certain information regarding insulin manufacturer assistance programs.
• A1899 (Conaway/Speight/Vitale/Mukherji) — Expands authority of pharmacy technicians in administering drugs and vaccines and permits certain pharmacists and pharmacy interns, externs and technicians to administer COVID-19 vaccine.
• This bill was signed into law at the beginning of February.

Additionally, Assemblywoman Shavonda Sumter (D, LD35) announced that she will not seek reelection. The current Chair of the Assembly Community Development and Women’s Affairs has served in the Assembly since 2012 and on the New Jersey Legislative Black Caucus. BioNJ is thankful for Assemblywoman Sumter’s commitment and service and looks forward to her finding new ways that New Jersey can benefit from her Intellect and other talents.

To read a statement by Assemblywoman Sumter, click here.

Finally, the next Prescription Drug Affordability Council meeting is scheduled for February 20. BioNJ will monitor and update upon any developments relevant to the life sciences ecosystem.

On February 13, Robert F. Kennedy Jr. (RFK) was confirmed to lead the Department of Health and Human Services (HHS) by a vote of 52 to 48, with Senator Mitch McConnell representing the sole vote against his confirmation among republican senators.

In his responses to questions following the initial hearings, Secretary Kennedy acknowledged that the March-In-Right provision, as outlined by the Bayh-Dole Act, is an unsuitable mechanism for the federal government to impose price controls.

BioNJ looks forward to taking every opportunity to ensure that the federal government is fully aware of the fundamental driving force of the life sciences sector in discovering new opportunities to reduce suffering and promote well being — and that our sector is an optimal partner in pursuing longer and healthier lives globally.

On February 7, the National Institutes of Health (NIH) announced a 15% across-the-board reduction in indirect funding allocations. Indirect costs are devoted to sustaining the administrative and personnel expenses that are required for laboratories at universities to conduct the research that fuels the earliest stages of R&D.

BioNJ continues to connect with the entire landscape of institutions which are recipients of this funding to develop as accurate a picture as possible of the ramifications of this cut to indirect cost funding.

Given that research institutions are a critical part of the economic activity that underlies the United States’ dominance in biomedical innovation, these reductions will inevitably reverberate from academia to the private sector. Fundamentally, this will cause a diminution of the kind of workforce that President Trump and past presidents have all highlighted as priorities for growth.

Please reach out to Ian McLaughlin, Ph.D., VP of Government Affairs, with any insights regarding the impact of this announced cut to indirect costs: IMcLaughlin@BioNJ.org.

For coverage of the cut to NIH indirect cost funding in Science, click here.

Last week, BioNJ released the following statement:

BioNJ's Statement on the Announced Cut of Indirect Cost Rates

at the National Institutes of Health (NIH)



"BioNJ is concerned by the announced cut of indirect cost rates at the National Institutes of Health (NIH). The life sciences ecosystem in the United States is the world’s dominant source of biomedical innovation. A critical component of that international competitiveness is the relationship between academic biomedical research and the ability of the life sciences sector to translate those innovations at their earliest stages to medicines and treatments that improve the lives of Patients. This relationship is key, and the federal government’s support for the innovation that takes place at universities is at the heart of why the United States leads the world in the research that quite literally saves and improves lives. Beyond that, investment in America’s universities, and investment in the NIH, have been repeatedly shown to produce a significant return on investment — ultimately reducing rather than increasing costs.

These cuts will inevitably result in a diminished workforce among New Jersey’s universities and nationwide. These are the jobs that fundamentally enable the R&D at universities which are major contributors to the ability of the life sciences sector to support the global competitiveness of the United States — and equally importantly — result in the treatments and cures that are the main source of hope for Patients worldwide. Ideally, the Trump administration will reconsider seeing these funding reductions as a potential cost saver and will rather appreciate that it is an investment in the nation’s national competitiveness and ultimately a cost saver."

The bill, which is devoted to accelerating pediatric cancer treatments and increasing access to medications developed to treat rare diseases that children confront, has been reintroduced in the U.S. House of Representatives. The bill is an amalgamation of two efforts, including the Creating Hope Reauthorization Act. As a result, this bill would reauthorize the pediatric priority voucher (PPRV) program, which is critical to catalyzing the development of significantly more therapeutics that can save lives.

BioNJ looks forward to continuing to support these priorities and will find every opportunity to advocate to do so.

To read a press release regarding the bill, click here.

On February 13, the President issued an Executive Order (EO) that establishes a Commission devoted to addressing chronic illnesses. The EO directs a variety of federally funded institutions to prioritize addressing root causes for illnesses, disease prevention and establishes the Commission that includes the leaders of a wide variety of departments, including the Commissioner of the FDA, Director of the CDC, Director of the NIH, chairs of economic agencies, the Director of the Office of Science and Technology Policy and several others.

The EO orders an assessment to the President focused on these policy priorities within 100 days.

BioNJ will continue to convey the important role that the life sciences sector plays in achieving better health across the United States and looks forward to finding opportunities to support this shared effort.

To read the EO, click here.

Last week, the U.S. Senate Finance Committee approved the President’s nominee to serve as the United States Trade Representative (USTR). If approved by the Senate, Jamieson Greer would follow Katherine Tai, former USTR under the Biden Administration. Greer formerly served as an officer in the U.S. Air Force Judge Advocate General’s Corps, and served as Chief of Staff to the USTR from 2017-2020.

Given the critical discourse associated with intellectual property (IP), the TRIPS waiver and the role that U.S. protection of the inventions of companies in this country, BioNJ looks forward to continuing to connect with the USTR to ensure that the U.S. IP protection framework remains intact and strong. As Debbie Hart, President & CEO of BioNJ, conveyed in testimony before the United States International Trade Commission, "the integrity of the U.S. legal framework that protects innovation is crucial to the ability of this sector to continue attracting the investment that is essential to sustaining biomedical innovation".

Earlier this week, STAT and Reuters both reported on staffing cuts at the FDA. According to the FDA’s recent deputy commissioner for foods, Jim Jones, 89 people have been fired from the Administration’s food division with a focus on employees who were recently hired. Reuters reported that about 20 people in the FDA’s office of neurological and physical medicine devices have also been fired.

To read the article published by STAT, click here.

To read the article published by Reuters, 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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