April 2, 2025

Two bills that BioNJ vigorously supported were passed by the State Assembly last week.

A5217, sponsored by Assembly Majority Leader Greenwald (D, LD6) and the Senate President, was passed unanimously by the Assembly. BioNJ is pleased to see such universal support for a policy that will fundamentally ensure that Patients truly receive the affordability assistance that has always been intended for them and avoid the assistance being absorbed by PBMs and their parent companies. In the Senate, the bill is currently referred to the Senate Budget & Appropriations Committee, and we are hopeful to see the bill make progress and reach the Governor’s desk for a signature soon.

Secondly, a bill that will require coverage for biomarker diagnostic testing, passed both the State Senate and Assembly, A4163. BioNJ was pleased to see unanimous support for this bill in both the Senate and Assembly, and we were happy to offer as much support as possible to the coalition led by the American Cancer Society – Cancer Action Network. Click here to read BioNJ's recent op-ed in support of the bill as published in ROI-NJ.

Meanwhile, the Legislature has commenced budget hearings to consider the Governor’s proposed budget. While both the Senate and Assembly will continue holding hearings, Senate Budget and Appropriations Chair Sarlo (D, LD36) noted the following at the opening of their first public hearing held at NJIT:

“...I’m quite confident, the budget that has been produced will be modified. There are certain fees and taxes that were proposed that I’m quite certain will be eliminated...and, the biggest unknown: what will happen to our federal funding, especially with regards to Medicaid and higher education.”

To watch the first seven-hour Senate Budget hearing, click here.

Last week, the Trump administration notified Governor Murphy that New Jersey has lost $350 million in federal funding as a component of a cut of the federal Department of Health and Human Services (HHS) of $11.4 billion. The rationale provided by the federal government is that funding for state programs associated with COVID-19, with HHS conveying “The COVID-19 pandemic is over, and HHS will no longer waste billions of taxpayer dollars responding to a non-existent pandemic that Americans moved on from years ago."

The Governor has shared that he is contemplating legal action against the Trump administration to recover the funding that was already approved by Congress as a part of the COVID-19 pandemic funding. States were permitted to allocate funding to programs beyond COVID-19.

While the Governor has not shared specifics regarding which programs in the State would be affected, nor how he sees the budget that he proposed in February might evolve as the Legislature contemplates the budget in light of this announcement, he noted “We will do everything we can to restore this funding — including taking legal action.” He also noted that the cuts will make it harder for children to access vaccination, for diagnostics to be processed efficiently and for Federally Qualified Health Centers to deliver care.

To read a statement from Governor Murphy, click here.

Peter Marks, the former Director of the Center for Biologics Evaluation & Research (CBER) in the FDA, announced his resignation at the end of last week. Dr. Marks, who has served in the role since 2016 and even longer in the FDA, has been widely appreciated as central to a thoroughly productive period of biomedical innovation — and also was a major contributor to the unprecedented productivity of Operation Warp Speed, bringing crucial vaccines to Patients in record time.

Debbie Hart, President and CEO of BioNJ, released the following statement on Dr. Marks' resignation:

"Dr. Peter Marks has been a leader of the life sciences sector during one of the most productive periods in our history, overseeing the testing and approval of a tremendous number of new treatments and cures for Patients around the world. His wisdom and insights are irreplaceable. BioNJ is concerned that the ability of the Food & Drug Administration to ensure that new medications are safe, effective and accessible will be diminished by his absence.

Dr. Marks has always been generous with his time, actively participating in numerous BioNJ events to offer his invaluable insights to New Jersey's life sciences community.

BioNJ thanks Dr. Marks for all of his contributions to the life sciences ecosystem and to Patients globally. We are hopeful that he will continue to do what he can to ensure that every Patient — regardless of who they are or where they are located — has access to the most advanced and effective treatments, Because Patients Can't Wait.^®" 

John Crowley, President & CEO of the Biotechnology Innovation Organization, released the following statement on Dr. Marks’ resignation:

Last week, Federal Trade Commission (FTC) Chairman Andrew Ferguson, announced the appointment of Taylor Hoogendoorn as Deputy Director of the Bureau of Competition and Katherine White as Deputy Director of the Bureau of Consumer Protection. Hoogendoorn previously clerked for Supreme Court Justice Samuel Alito and then worked at a private practice law firm in Houston, TX. White spent many years at the FTC, including as Attorney Advisor to former Commissioner Noah Phillips under the first Trump administration.

To read the full announcement from the FTC, click here.

On March 28, the President announced intended tariffs on pharmaceuticals coming into the United States — and also highlighted Ireland’s pharmaceutical industry as a target for tariffs.

To watch coverage by Bloomberg, click here.

To read coverage by the BBC, click here.

After conducting a survey of BIO member companies, the Organization released the results, noting that “U.S. Biotechs Sound the Alarm.” The findings include:

1. Tariffs on European Union and Canadian imports would increase manufacturing costs for 94% and 82% of biotech firms, respectively.
2. 70% of companies anticipate higher manufacturing costs due to tariffs on China.
3. Tariffs on the European Union would force 50% of biotech firms to identify new research and manufacturing partners.
4. More than 50% of biotech firms predict “increased difficulty” in funding and conducting research if EU tariffs are enacted.
5. 80% of biotech firms would need at least 12 months to find alternative suppliers; 44% would need over two years.

The survey noted that sudden tariffs would fundamentally punish American companies, threaten vital research projects and imperil United States leadership in biomedical science. We hope that the administration will prioritize Patients as past administrations have in exempting medicines from tariffs.

To read a statement from BIO, click here.

Secretary RFK Jr. has announced plans to diminish the HHS workforce by 25% and create a new agency for a “Healthy America”. He noted that his plan will save $1.8 billion annually and cut the agency’s 28 divisions by almost half. Combined with earlier cuts, the Department anticipates roughly one-quarter of its full-time workers to depart. The plan also includes a consolidation of the 28 divisions into 15 and cutting the current 10 regional offices to five. The Secretary also conveyed that most of the job cuts will focus on administrators and an intention to hire more scientists and frontline health care providers.

The FDA, which is housed in HHS, is intended to decrease its workforce by approximately 3,500 full-time employees. A fact sheet released by HHS notes that these reductions will not affect drug, medical device, food reviewers or inspectors. The Centers for Disease Control & Prevention (CDC) is intended to have a 2,400 employee reduction and the Administration for Strategic Preparedness and Response (ASPR) will be moved under the CDC. The National Institutes of Health (NIH) will be diminished by 1,200 employees with a focus on procurement, human resources and communications. Finally, the Centers for Medicare & Medicaid Services (CMS) is intended to lose approximately 300 employees, though HHS notes that the “reorganization will not impact Medicare and Medicaid services.”

Layoffs are anticipated around May 27.

To read a fact sheet from HHS regarding this plan, click here.

To read coverage of the general announcement in STAT, click here.

To read coverage of the impact on the Food & Drug Administration (FDA), click here.

To watch the announcement by Secretary RFK Jr. on X/Twitter, 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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