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May 22, 2024

As we near the deadline for the State’s budget to be signed, July 1, legislative committees have resumed considering a variety of bills. This general schedule is expected to continue until the end of June, after which the Legislature will break for the summer.

New Jersey Legislative Update

Since our last Public Policy Update on May 8, several legislative committees have considered a few bills that are worth monitoring due to their relevance to the life sciences sector:


S3135 (Smith/McKeon) - Requires producers of plastic packaging and certain other plastic products to reduce quantity of plastic sold; restricts additional substances under "Toxic Packaging Reduction Act."


Prior to being amended by the Senate Environment and Energy Committee on May 13, this bill had an exemption for FDA approved products in a section of the bill — but this exemption did not appear to apply to a subsequent section that would prohibit the use of PFAS in any package, packaging component, or any product contained in a package. Following Committee amendments, an FDA exemption has been modified to apply more broadly. Please contact Ian McLaughlin, VP of Government Affairs, with any thoughts or concerns regarding the status of the exemptions for life sciences companies: IMcLaughlin@BioNJ.org.


S208 (Smith) - Requires producers of packaging products sold in New Jersey to adopt and implement packaging product stewardship plans.


S226 (Smith/McKeon) - Prohibits use by certain retailers of shipping box greater than two times volume of product being shipped.


A2365 (Tully/Murphy/DePhillips) - Increases amount of tax credits for investments made in certain technology business ventures under "New Jersey Angel Investor Tax Credit Act."


This bill was reported by the Assembly Science, Innovation and Technology Committee unanimously on May 16 — and BioNJ was glad to support this progress towards ensuring that New Jersey’s Angel Investor Tax Credit remains nationally competitive. We look forward to continuing to advocate for this prudent policy in both the New Jersey Senate and Assembly.

Additionally, on May 17, the Assembly Science, Innovation and Technology committee received testimony from invited guests concerning the use of artificial intelligence (AI) by New Jersey businesses. The hearing focused on opportunities to support workforce development in the AI field. Senior Vice President, Global Head of Data Science & AI at BioNJ member company, Genmab, Hisham Hamadeh, shared insights about our industry, the use of AI, and what policymakers can do to create an ecosystem that will allow the AI field to thrive in New Jersey.

Biotechnology Innovation Organization (BIO) Conducts Survey on

Supply Chain Connections with China

BIO’s survey of 124 companies found that 79% have at least one contract or product with a CDMO/CMO that is either based in China or owned by a Chinese entity. This effort was, in part, motivated by the recent introduction and movement of legislation that would target relationships with Chinese entities at the federal level, which would severely diminish the ability of Chinese biotech companies from pursuing partnerships and business in the United States.


However, on May 9, legislators in the U.S. House produced a new draft of the BIOSECURE Act. The latest draft incorporates language that would help to avoid sudden and severe disruptions to supply chain relationships.


BioNJ appreciates the receptivity of New Jersey’s congressional delegation to the nuances that are inherent to the biomedical supply chain and looks forward to continuing to work with every office to ensure that the life sciences sector in the Garden State continues to thrive.


For comments from BIO and a statement from BIO CEO, John Crowley, click here.

Rare Pediatric Priority Review Vouchers Program Progresses in U.S. House

The rare pediatric disease priority review vouchers program (PPRV) is a program devised to incentivize the development of therapeutics for rare pediatric diseases, enabling approved sponsors to receive priority review for a different product or sell the voucher to another sponsor.


H.R. 7384 was advanced by the House Energy & Commerce Health Subcommittee, which would extend the PPRV program. Given the impact that the implementation of this policy has already had on the development of therapeutics to treat one of the most vulnerable communities nationwide, BioNJ is thrilled to see this effort make progress and will continue to convey the virtues of ensuring this program continues to incentivize the innovation on which children and their loved ones are relying.

Bayh-Dole Coalition Releases Video on Importance of the Bayh-Dole Act and Perils of Exploiting March-In

Last week, the Bayh-Dole Coalition, which is devoted to conveying the importance and efficacy of the Bayh-Dole Act and is led by one of the central framers of the legislation, Joe Allen, released a video to articulate the importance of this legislation. The video includes interviews of a variety of directors of technology transfer at leading biomedical research universities, including Johns Hopkins University, Washington University in St. Louis, Emory University, Duke University, Wake Forest University, Dartmouth College, Florida State University as well as the Association of American Universities.


BioNJ is proud to support the efforts of the Coalition and will continue to convey the innovation that the Bayh-Dole Act has accelerated nationwide to policymakers.


To view and share this video, click here.

Senate Committee on the Judiciary Holds Hearing on Competition in the Prescription Drug Market

Yesterday, the Senate Judiciary Committee held a hearing titled “Ensuring Affordable & Accessible Medications: Examining Competition in the Prescription Drug Market”.


To view the hearing, click here.

Centers for Medicare & Medicaid Services Announces Medicaid Drug Rebate Program (MDRP) Proposed Rule Not to be Finalized

Last week, the Centers for Medicare & Medicaid Services (CMS) announced, following input on the proposed rule for the Medicaid Drug Rebate Program (MDRP), that it will not be finalizing the proposal associated with stacking. The MDRP rule would require manufactures to “stack” all price concessions across the entire supply chain for a single unit of a medication, potentially increasing Medicaid rebate liabilities with inevitable broader ramifications for the 340B program and commercial markets. While we are glad to see that CMS will not finalize this stacking provision, BioNJ will continue to monitor for any developments associated with the MDRP.


To read the CMS statement, click here.

House Energy & Commerce Committee Holds Hearing on Regulation by the Food and Drug Administration (FDA)

Today, the U.S. House Energy & Commerce Health Subcommittee is holding a hearing entitled “Check Up: Examining FDA Regulation of Drugs, Biologics, and Devices.” The hearing will include testimony from several key FDA officials regarding what is and is not working well at the FDA.


To view the hearing, click here.

We Need Your Help: Support BioNJ Policy and Advocacy Efforts

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.

BioNJ | www.BioNJ.org

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