As the New Jersey Legislature winds down toward the end of the year, there will be one more voting session in the Senate and Assembly on Thursday, December 21 — followed by another opportunity for committees to meet in early January before the next legislative session begins. BioNJ will provide updates upon the emergence of any new policy developments relevant to the life sciences.

Happy holidays to all!

Last week, two bills moved through Assembly committees that are worth noting. A1255, which moved through the Assembly beginning in June of 2022, was significantly amended when it moved unanimously through the Assembly Financial Institutions and Insurance Committee (AFI). The bill now focuses exclusively on implementing guardrails on prior authorization practices, repealing and replacing the “Health Claims Authorization, Processing and Payment Act” (HCAPPA) passed years ago. In particular, Section 10 of the original language, which dealt with step therapy/“fail first” practices, was omitted during negotiations with the opposition to the bill.

While the new language will implement welcome guardrails on prior authorization, we look forward to pushing for more effective policies during the next legislative session, along with our coalition partners, to ensure that Patients are able to receive the medications that they and their physicians determine are best for them when they need them. 

In addition, S3604, which authorizes the use of Internet-based services to obtain discounts on prescription and non-prescription drugs or devices, including telemedicine, also moved through AFI unanimously. The bill will authorize Patients to use memberships with these platforms and stipulates that licensees of the Board of Pharmacy will not be penalized for allowing Patients to use discounts from the healthcare platforms as a part of payment.

S332/A1971, which is a bill focused on consumer data privacy, passed the Senate last February and continues to be considered in the Assembly. It is an expansive bill that will include implications for the conduct of clinical trials throughout the State. On Monday, December 18^th, the bill was recommitted to the Assembly Judiciary Committee for the incorporation of extensive amendments. While the majority of amendment language was most directly relevant to other industries, language that more effectively insulates the collection and communication of clinical trial data from the bill’s provisions was amended into the bill. 

However, one component of proposed amendments that we and our partners shared focused on expanding the scope of this exemption to include a reference to the good clinical practice guidelines issued by “The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.” While we had hoped that this language would also be adopted, the bill sponsor expressed a willingness to address any outstanding issues during the next legislative session. Given that, if passed and signed, the bill would take effect a full year following its enactment. We look forward to working with legislators in 2024 to ensure that the fundamental goals of its provisions are achieved while not unnecessarily encumbering or preventing clinical trials from being conducted in New Jersey—and we are grateful for the receptivity of the bill’s sponsors and legislative leadership to the concerns of the life sciences sector.

Additionally, a bill that would establish a three-year sickle cell disease pilot program is posted for a final floor vote tomorrow. A4052, the Assembly version with Prime Sponsor Asw. Reynolds-Jackson (D-LD15), Asm. Conaway (D-LD7)—as well as a variety of additional prime and co-sponsors—was passed by the Assembly last June. If S2710, the Senate version of the bill with Sens. Turner (D-LD15) and Zwicker (D-LD16), is passed alongside the Assembly version tomorrow, the bill will be ready for the Governor’s signature. We are pleased to see this bill make progress and hope to see it ultimately enacted.

Finally, while the CBT Surtax is still expected to expire at the end of the session as the Governor has consistently expressed, calls have been emerging to extend the surtax once again with the particular goal of funding NJ Transit. BioNJ will continue to monitor developments until the end of the legislative session and into the next session. 

For further discussion of these efforts, please contact Ian McLaughlin, VP, Government Affairs, at IMcLaughlin@bionj.org.

On Monday, the Federal Trade Commission (FTC) and Department of Justice (DOJ) released new merger guidelines that have implications for the entire economy, including health care. Given that the announcement reflects the agencies’ proposal earlier this year, there are significant concerns, given the unique role that mergers & acquisitions play in innovation and the emergence of novel therapeutics from the life sciences sector. BioNJ, along with our partners, will continue to engage policymakers to convey the ramifications that a diminution of the ability of large companies to facilitate the access that Patients have to biomedical innovations.

For a statement from the Partnership for the US Life Science Ecosystem (PULSE), click here.

As we continue moving towards the next election following the election last month, several current and former policymakers have announced their intentions to run for offices at various levels of State and federal government.

On December 11, former Senate President Steve Sweeney announced his campaign for New Jersey Governor. This was followed by endorsements from several county chairs in South Jersey. He joins Jersey City Mayor and fellow Democrat, Steve Fulop, who announced his candidacy in April.

In September, Mayor of Mendham Borough Christine Serrano Glassner, a Republican, announced that she will run for the U.S. Senate seat currently occupied by Senator Bob Menendez (D-NJ). As we covered in early November, First Lady Tammy Murphy announced her campaign for the Senate seat in mid-November.

Additionally, longtime State Assemblyman and Chair of the Assembly Health Committee Herb Conaway, announced his candidacy for the U.S. House seat currently occupied by Rep. Andy Kim (NJ-3). Asm. Conaway will face his district mate in the State’s 7th Legislative District, Assemblywoman Carol Murphy, in the race for this congressional seat.

Finally, Hoboken Mayor Ravi Bhalla, announced his candidacy for the seat in the U.S. Congress currently occupied by fellow Democrat Rep. Rob Menendez (NJ-8) on December 12.

On December 7, the Biden Administration announced new efforts intended to lower prescription drug costs. While the announcement includes broader initiatives, one component targets March-In authorities and the Bayh-Dole Act. BioNJ is continuing to coordinate with our partners, including the Bayh-Dole Coalition, to convey why misusing this provision represents a fundamental misunderstanding of its purpose and to ensure that the ramifications of jeopardizing a policy that has been pivotal to the ability for the life sciences to thrive in the United States are heard by federal policymakers.

The Bayh-Dole Coalition held a fireside chat to discuss the significance of these policy decisions last week. To view the conversation, click here.

On December 11, the U.S. House of Representatives passed the “Lower Costs, More Transparency Act” (H.R. 5378). The bill was passed by the House by a significant bipartisan majority of 320-71 and is the first major bill pursuing transparency regarding the business practices of Pharmacy Benefit Managers (PBMs). BioNJ is pleased to see this legislation progress and will continue to advocate for the implementation of further guardrails on the practices of PBMs to ensure that Patients receive both the affordability assistance — and, most importantly, the treatments and cures — that they deserve.

A poll commissioned by the Biotechnology Innovation Organization (BIO) and conducted by Morning Consult, released earlier this month, demonstrates that a strong majority of U.S. voters (72%) find that research on rare disease treatments is very important, and more than four-in-five view the expansion of incentives for developing new therapeutics for rare conditions as being a critical priority.

BioNJ is pleased that Rep. Gottheimer (NJ-5) was among the first cosponsors of the ORPHAN Cures Act in the U.S. House, and we will continue to engage the New Jersey delegation to ensure that our policymakers support the passage of this bill on behalf of the Patients who confront rare diseases nationwide.

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 2024. 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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