The Legislature remains in recess, with the Assembly expected to meet on November 20th and Senate on November 27.

Yesterday, the United States International Trade Commission (ITC) released its report on the potential expansion of the TRIPS waiver to include diagnostics and therapeutics at the behest of the United States Trade Representative (USTR). While we are still reviewing the 500-page report, we hope that the USTR will consider the ramifications that such an expansion would have— and particularly in the context of public health emergencies that have been concluded by both the United States and World Health Organization.

In March, Debbie Hart, President & CEO of BioNJ, provided oral testimony and post-hearing briefs to the ITC that articulated the impact that such an expansion of the waiver would have on the life sciences sector in New Jersey. Debbie Hart released the following statement in response to the ITC report.

John Murphy, Chief Policy Officer of the Biotechnology Innovation Organization, released the following statement:

“This report reiterates our stance that there is no credible evidence supporting the need for an expanded TRIPs waiver -- or other expansions that would hinder critical intellectual property protections within the biomedical field -- to increase global access to COVID-19 diagnostics and therapeutics. 

“Innovation and intellectual property go hand-in-hand. We look forward to advocating for American ingenuity and the global innovation ecosystem that ushers in new generations of treatments. We will continue to work with this Administration to find solutions that encourage innovation within the life sciences fields and increase patient access to critical diagnostics, therapeutics, and vaccines.” 

As of the release of this update, the U.S. House of Representatives still has yet to name a new Speaker. While several members of the majority party in the House were considered, with Rep. Steve Scalise (R-LA) winning nomination by the Republican caucus by a narrow margin of 14 votes, then followed by Rep. Jim Jordan (R-OH) being nominated after the withdrawal of Rep. Scalise, none have secured the 217 votes needed to ultimately take the gavel. The House has been without a Speaker for over 2 weeks, and Rep. Jordan was 17 votes short of the necessary 217 to be elected following the first round of voting yesterday. Today, two fewer Republicans voted for Rep. Jordan to become Speaker in the second round of voting relative to the first round.

Given that any significant legislation will be delayed until a Speaker is ultimately named, and the looming end of the current spending bill signed at the end of last month, BioNJ hopes that the House is able to determine leadership and come to an agreement prior to the bill’s end date next month.

Earlier this month, Governor Murphy signed legislation that is going to enable the Commission on Science, Innovation and Technology (CSIT) to provide grants to employees of institutions of higher education, such as professors and researchers at institutions like Rutgers University. S3402, led by Senator Zwicker (LD-16) and Assemblyman Tully (LD-38), will enable the Commission to provide the resources and support that can accelerate the earliest stages of innovation at these institutions throughout the State. BioNJ is pleased with this new policy and looks forward to even greater innovation in the life sciences and beyond throughout New Jersey as a result.

On October 10, the Senate HELP Committee released a report entitled,-“Major Non-Profit Hospitals Take Advantage of Tax Breaks and Prioritize CEO Pay Over Helping Patients Afford Medical Care.” The report, which was compiled by the staff of Senate HELP Chair Sanders, explores 16 of the largest non-profit hospital systems.

In addition, the Senate HELP Committee will consider the nomination of Dr. Monica Bertagnolli to be the next Director of the National Institutes of Health (NIH). This will be the first nomination hearing for the department in over 20 years. Dr. Bertagnolli served as the sixteenth Director of the National Cancer Institute (NCI), conducted research in oncology and was the first woman to hold the position of Chief of Surgical Oncology at the Dana-Farber Cancer Institute.

The Senate HELP Committee hearing took place today at 10:00AM. Concerns regarding the potential implementation of drug pricing provisions from Ranking Member Cassidy (R-LA) were raised, and much of the initial questioning focused on drug pricing policies — and particularly “reasonable pricing” policies, which would require any therapeutics arising from any funding from the NIH to be pegged to international prices. Dr. Bertagnolli conveyed that she would do what she can to ensure affordable care is available to everyone who needs it, but she did not speak to Committee Chair Sanders’ (D-VT) explicit question of whether she would implement these specific policies. In addition, Dr. Bertagnolli pledged to preserve the integrity of the Bayh-Dole Act following questions from Senator Marshall (R-KS).

Tomorrow at 10:00AM, the House Subcommittee will hold a hearing entitled “Intellectual Property and Strategic Competition with China: Part III - IP Theft, Cybersecurity and AI.” The hearing will focus on current capabilities and risks in the race between the U.S. and China in the development of artificial intelligence, including cybersecurity implications and potential impacts on U.S. intellectual property protections.

On the topic of AI, the House Energy & Commerce Committee is holding a hearing titled “Safeguarding Data and Innovation: Building the Foundation for the Use of Artificial Intelligence” today. This will be the first in a series of hearings that the Committee will hold focused on AI across every economic sector.

As noted in the most recent Public Policy Update, the National Institutes of Health’s Small Business Innovation Research (SBIR) program is soliciting proposals for new contracts. A resource based in New Jersey, the Small Business Development Center (NJSBDC), offers coaching and guidance to companies based in New Jersey that are looking to apply to the SBIR/STTR program.

For those interested in assistance on applications to SBIR/STTR, contact Christian Pichardo at Christian.Pichardo@njsbdc.com.

On October 13, the Securities & Exchange Commission (SEC) announced the adoption of a new rule focused on providing greater transparency to investors and other market participants by requiring greater disclosures. The goal of this rule is to inhibit illegal behavior associated with some short sellers, such as promulgating false social media campaigns with the intention to artificially reduce share prices. While this positive new rule will apply to more sectors than the life sciences, it is particularly beneficial to the industry due to its uniquely protracted R&D periods relative to other sectors.

On October 12, additional charges against U.S. Senator Bob Menendez (D-NJ) were released. The new charges focus on undue interactions that the Senator has allegedly had with a foreign government. To read this superseding indictment, click here.

On October 11, BIO CEO, Rachel King, wrote an article published in Fortune entitled, “We’re on track to miss out on the next Katalin Karikó as women in STEM continue to bear the brunt of the pandemic’s lasting impact.” Among the points she raises is the fact that women departed from the workforce at greater numbers than men during the COVID-19 pandemic, resulting in a sustained workforce impact and requiring an intentional course correction.

The actuarial and consulting firm, Milliman, released a report earlier this month focused on the Medicare Prescription Payment Plan (MPPP or M3P) under the Inflation Reduction Act. This program allows beneficiaries to spread their out-of-pocket costs over a full year, enabling the maximum of $2,000 to be paid over 12 monthly payments.

As the report demonstrates, payment amounts under M3P are significantly different relative to the prior alternative over time.

There are three ways that votes can be submitted for the upcoming General Election: vote by mail, in-person early voting and at polling places on Election Day.

For more information on ways to vote, 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 2023. 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