As the State has entered budget season, we look forward to the Governor’s budget address at the end of the month — as well as his remarks at the opening of BioNJ’s Annual Dinner Meeting and Innovation Celebration tomorrow evening. We hope to see you there!

Today, Debbie Hart, President & CEO of BioNJ, penned an op-ed in The Daily Record focused on how the nation’s strong intellectual property framework has nurtured the growth of our innovative life sciences sector. In particular, the article notes how pivotal the Bayh-Dole Act has been to the sector in cultivating the kinds of partnerships that are critical to the sector, as well as the perils of any potential expansion to the TRIPS waiver.

To read the op-ed, click here: "Washington Must Not 'March In' on NJ Universities, Life Sciences Industry and Patients"

While the 221st Legislative Session has only just started, there are a few bills that have been either posted, identified as legislative priorities or are worth noting.

A1838 (Conaway/Speight/Ramirez) / S1161 (Mukherji) – “Establishes New Jersey Active Pharmaceutical Ingredient Regulatory Commission”. This bill was initially posted to be heard for discussion only in the Assembly Health Committee on January 29th. While the hearing was ultimately cancelled for unrelated reasons, the bill contained a few provisions that we are evaluating for any potential concerns.

S1390 (Singleton/Pou) – “Requires carriers to pass prescription drug savings to consumers.” This bill would require that any rebates provided by manufacturers be transferred to carriers and then used to lower premiums or allow for remittance directly for individuals at the point of sale to reduce out of pocket costs.

A1421 (Haider/Conaway/Swain) / S1042 (Greenstein/Smith) – "“Protecting Against Forever Chemicals Act"; establishes requirements, prohibitions and programs for regulation of perfluoroalkyl and polyfluoroalkyl substances (PFAS).” This bill has been reintroduced and is expected to be heard this session.

S1413 (Singleton) – Requires health insurance coverage of preimplantation genetic testing with in vitro fertilization under certain conditions.

S210 (Smith) – “Provides corporation business tax and gross income tax credits for purchase and installation of electric vehicle charging stations and for commercial zero emission vehicle fleet conversions.”

A3451 (Quijano/Reynolds-Jackson/Coughlin) – “Revises law concerning family leave to extend protection by reducing, over time, employee threshold from 30 employees to five employees in definition of employer.” This bill is posted to be heard tomorrow in Assembly Appropriations.

BioNJ will continue to monitor bills that are introduced or posted and provide updates regarding any with particular relevance to the life sciences ecosystem.

In response to the change to R&D expensing policies adopted as a function of the Tax Cuts and Jobs Act of 2017, a policy remedy to reenable immediate R&D cost expensing has made progress in the U.S. Congress. Last week, the House passed a package, the “Tax Relief for American Families and Workers Act”, that included a provision that would render R&D expenses 100% deductible through 2025. This would be retroactively applied to tax year 2022 and remain in effect for tax years before the first of 2026. Foreign research costs, however, will continue to be amortized over 15 years.

BioNJ is gratified to see that the congressional delegation from New Jersey has provided among the greatest support among State delegations for this policy nationally, and we will continue to convey the importance of this policy remedy until this policy is ultimately adopted.

The Ensuring Pathways to Innovative Cures (EPIC) Act (H.R. 7174), which would address the “small molecule penalty” or “pill penalty” generated by the current provisions of the Inflation Reduction Act’s (IRA) drug pricing provisions, was introduced last week by Reps. Greg Murphy (R-MD), Don Davis (D-NC) and Brett Guthrie (R-KY). This bill would address the disparity in how the Inflation Reduction Act’s (IRA) pricing provisions approach small vs. large molecule medications. The bill would accomplish this by raising the length of time that small molecules are provided by the legislation to be equivalent to large molecules by striking “7 years” and inserting “11 years” in the legislation.

Given the impact that these provisions have had, and are projected to continue having, BioNJ looks forward to supporting the passage of this bill and will engage New Jersey’s congressional delegation to convey the importance of adopting these provisions.

For a statement from Rep. Greg Murphy, click here.

To read the bill, click here.

On January 25th, a bill was introduced into the U.S. House by the Chair and Ranking Member of the House Select Committee on the Strategic Competition between the U.S. and the Chinese Communist Party that is devoted to preventing U.S. funding to be available to biotech companies based in countries deemed to be adversaries. The “BIOSECURE Act” is intended to restrict federally funded medical providers from using foreign adversary biotech companies of concern.

For a statement from the Select Committee, click here.

Last week, the Biden Administration and the U.S. Department of Health and Human Services announced that it was sending their initial offers to drug manufacturers for the first drugs selected for the pricing provisions of the Inflation Reduction Act. All of the manufacturers receiving these initial offers have until early March to propose counteroffers, which can be followed by subsequent interactions until decisions are ultimately made.

Given the challenges that these provisions will face in the federal judiciary, as well as the prospect of addressing some of the more egregious provisions in this legislation, BioNJ will update upon any developments regarding the implementation of these policies.

The Chair (Sen. Ron Wyden, D-OR) and Ranking Member (Sen. Mike Crapo, R-ID) of the Senate Finance Committee released a bipartisan white paper focused on addressing shortages of generic medications. The group announced that the Committee will be focused on Medicare Part A & B payment reforms, new incentives along the supply chain, pilot incentive programs in Medicare Part D and reforms to the Medicaid Drug Rebate Program.

To read a statement from the Chair and Ranking Member, click here.

Last week, a bipartisan group of Senators sent a letter to the Chair of the Federal Trade Commission (FTC) regarding the body’s investigation into the business practices of pharmacy benefit managers (PBMs). The letter pursues updates on the status of the investigation, urging completion as soon as possible. It also notes progress that certain pieces of legislation have made, including S. 127 and S. 113, which would implement transparency and expand authorities of the FTC over PBMs and also require an assessment of the ramifications that consolidation and anticompetitive behavior have had on prescription drug pricing.

The Subcommittee’s hearing was focused on overall health care spending and opened with an emphasis on the “Lower Costs, More Transparency Act” (H.R. 5378), which has been passed by the U.S. House. The hearing also included a discussion of the roles that pharmacy benefit managers (PBMs) play in driving costs.

To watch the Committee’s hearing, click here.

Today at 9:00AM, the Trade Subcommittee of the U.S. House Ways and Means Committee is holding a hearing focused on the World Trade Organization’s 13th Ministerial Meeting later this month, at which the potential expansion of the TRIPS waiver from COVID-19 vaccines to encompass diagnostics and therapeutics will be discussed.

BioNJ will continue to convey the ramifications that adopting this expansion would have to policymakers, following the testimony that Debbie Hart, President & CEO of BioNJ, provided to the U.S. International Trade Commission and other outreach. We are hopeful that, given recent reporting, the Biden administration recognizes the crucial role that the nation’s intellectual property framework has played in promoting innovation in the life sciences — as well as the lack of evidence that adopting this expansion would result in increased access.

For information on the hearing, click here.

The Senate HELP committee will be holding a hearing tomorrow at 10:00AM entitled, “Why Does the United States Pay, by Far, the Highest Prices in the World for Prescription Drugs?”

To watch the Senate HELP Committee Hearing, click here.

The Senate Finance Committee will be holding a hearing tomorrow at 10:00AM entitled, “Artificial Intelligence and Health Care: Promise and Pitfalls”.

To watch the Senate Finance Committee Hearing, 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 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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