The Senate and Assembly have released their calendars, providing some clarity regarding what to expect from now until the end of the year. Despite an expectation that the Senate might reconvene prior to the election due to outstanding judicial appointments and confirmations, neither the Senate nor Assembly will reconvene prior to the elections on November 7.

The Assembly currently intends to meet on November 20 and the Senate on November 27 — a fair bit of time following the elections. Once both legislative bodies resume activity, a rather dense series of committee hearings and votes in the lame duck period are anticipated on Mondays and Thursdays through December.

As a reminder, every seat in the Legislature is up for a vote and there will be over 30 new occupants of seats — either by members of the Assembly moving to the Senate or by newly elected legislators. As a result, the next Legislature is going to be composed of a significant number of new legislators.

Given that this is all subject to change, BioNJ will update upon any changes to the current legislative calendar.

On Saturday, Congress ultimately passed a continuing resolution to maintain government funding levels until November 17, providing for additional time to pass FY 2024 appropriations. The Senate had voted 88-9 to pass the legislation, and while the House minority party represented most of the votes in the lower chamber, the legislation passed with a comfortable margin of 335-91. 

Yesterday, Rep. McCarthy (R-CA) was removed from the role of speaker following a motion to vacate brought by members of the House majority party by a vote of 216-210. As a result, Rep. Patrick McHenry (R-NC) took the gavel and now acts as speaker pro tempore until the next speaker is elected.



Considering the broad ramifications of a government shutdown, including an inhibition of the ability of the Food and Drug Administration (FDA) to review new submissions, BioNJ was pleased to see this shutdown averted. While the majority of FDA operations devoted to reviewing submissions are funded by the fees that the life sciences industry provides — amounting to 81% of the over 19,000 personnel involved — the FDA would be incapable of accepting new user fees to provide for the review of new submissions during a government shutdown. As a result, we hope that the Congress will come to a funding agreement prior to November 17 to avoid any unnecessary delay in the access that Patients will have to the newest generation of innovation in the life sciences.

Today, the Partnership for the U.S. Life Science Ecosystem, or “PULSE”, was launched to facilitate greater engagement and education of policymakers on the unique economic characteristics of the life sciences ecosystem. Given that federal agencies are contemplating new policies that would affect entities throughout the industry, this partnership is intended to convey clear, real-world perspectives on issues, including the role that mergers and acquisitions play in bringing innovations from the bench to the bedside.

As a member of PULSE, BioNJ looks forward to working with this coalition to ensure that the unique characteristics of this ecosystem are conveyed to policymakers.

For more information on PULSE, click here or contact Ian McLaughlin, Vice President of Government Affairs at BioNJ at IMcLaughlin@BioNJ.org.

A coalition of advocacy organizations and entities in the life sciences is preparing an amicus brief to be submitted to the U.S. Supreme Court for their consideration of the case involving FDA’s approval of mifepristone. As the ruling would not be limited to one therapeutic, it enables any entity to challenge the approval of all therapeutics irrespective of demonstrated safety, and extensively circumscribes FDA’s flexibility in the types of evidence it can consider, the ramifications of a potential ruling extend well beyond only the availability of mifepristone.

Accordingly, the coalition is soliciting entities throughout the life sciences to sign on to the amicus brief it will be submitting. Signatories will be collected until the end of the day on Friday, October 6.

For more information on the amicus brief or interest in signing on, please contact Ian McLaughlin, Vice President of Government Affairs, BioNJ at IMcLaughlin@BioNJ.org.

John Crowley, who has been a longtime leader in efforts to develop treatments and cures for rare and orphan diseases, testified before the House Committee on Energy and Commerce Subcommittee on Oversight and Investigations on September 20. Sharing his personal story of his family members diagnosed with a rare disease, Mr. Crowley explained how he reoriented his life towards addressing the rare condition that his family members were confronting — ultimately resulting in an enzyme replacement therapy that saved their lives. Further, Mr. Crowley explained the landscape of how the life sciences confront rare diseases, as well as the “dawn of a golden age” of innovation in the life sciences.

Mr. Crowley also characterized the inhibitory effects that certain provisions of the Inflation Reduction Act (IRA) will have on biomedical innovation — all being implemented at a time that has been particularly difficult for the industry, ultimately diminishing the opportunities for more success stories like Mr. Crowley's family's to emerge. He also discussed the journey of Amicus Therapeutics, the company he founded, in having a small molecule therapeutic approved —involving 13 years of research and massive investment — to treat Fabry Disease. His testimony also speaks to the problematic provisions in the IRA associated with orphan drug indications.

BioNJ is proud to have awarded Mr. Crowley the Dr. Sol J. Barer Award for Vision, Innovation and Leadership in 2011, and we continue to be grateful for his resolute advocacy on behalf of Patients.

To view John Crowley’s testimony, along with the rest of the Subcommittee hearing, click here.

The longest-serving woman in U.S. Senate history, Senator Dianne Feinstein (D-CA), passed away at the end of last week. Following an acknowledgement of the pioneering legacy of Senator Feinstein’s service to the country, Governor Newsom selected Laphonza Butler to serve in Sen. Feinstein’s seat until the end of her term, which will be in January 2025.

On October 2, the U.S. District Court for the District of Columbia struck down a federal rule that permitted health insurers to exclude copay assistance provided by drug manufacturers from counting towards beneficiaries’ out-of-pocket costs. The case was brought against the U.S. Department of Health and Human Services by a coalition of Patient advocacy groups along with three Patients who depend on copay assistance and who have had to confront copay accumulator policies.

Given the impact that copay accumulator policies have on Patient access and affordability, and the ability for insurers to essentially pocket copay assistance, this is a salutary ruling from the perspective of Patients.

For comments on the ruling from the HIV+Hepatitis Policy Institute, click here.

At the end of last week, Senator Cassidy (R-LA), who is the Ranking member of the Senate Health, Education, Labor and Pensions (HELP) Committee, announced an investigation into how some hospital systems spend revenues derived from the 340B program. Initially devised in 1992 to ensure that Patients with lower incomes are able to access the medications that they need, 340B was modified in 2010 to adopt new guidance that enabled the use of an unlimited number of contract pharmacies under the program. Since then 340B has grown to be second only to Medicare Part D in size. As a result, there are concerns that the program is now operating in a fashion that fails to serve the Patient population for which it was originally conceived.

Among a variety of concerns, an assessment conducted by IQVIA in 2022 found that the “only claims segment displaying substantial evidence of Patient discount-sharing was the 1.4% of branded, 340B-eligible claims at contract pharmacies that used a 340B discount card.” Additionally, there are concerns that the program lacks transparency and oversight. We look forward to the findings of this assessment of 340B.

Last Thursday, September 28, the Bayh-Dole Coalition sent a letter to the Senate Health, Education, Labor and Pensions Committee (HELP), the Chair and Ranking Member of the House Ways and Means Committee, and to Secretary Becerra of Health and Human Services regarding both the Bayh-Dole Act and 28 U.S.C. Section 1498. The letter, signed by 25 scholars, former judges and former government officials emphasizes that these policies were never intended to enable the federal government to arbitrarily set prices in the life sciences.

On Monday, October 2, it was announced that Katalin Karikó and Drew Weissman, two scientists who were critical to the development of the mRNA vaccines developed to treat COVID-19, were awarded the 2023 Nobel Prize in Physiology or Medicine. The evolution of these crucial vaccines from scientific theory to lifesaving therapeutics, administered over 13 billion times and saving millions of lives, is a testament to the capabilities of effective partnerships between government and the life sciences industry. BioNJ applauds both scientists and is grateful for the ingenuity and perseverance of Drs. Karikó and Weissman. We look forward to their future innovations.

On September 19, the bipartisan Maintaining Investments in New Innovation (MINI) Act was introduced. The bill essentially addresses therapeutics that would otherwise be considered small molecules by the Inflation Reduction Act’s price provisions, but are genetically targeted, to render them being treated as large molecules.

The National Institutes of Health’s Small Business Innovation Research (SBIR) is soliciting proposals for new contracts. This is devised to provide early stage funding to small businesses that are developing cancer technologies, and this year’s topics are the following:

• NIH/NCI 455 - Point-of-Care Detection of Prostate-Specific Antigen
• NIH/NCI 456 - Rapid and Affordable Point-of-Care HPV Diagnostics for Cervical Cancer Control
• NIH/NCI 457 - Technologies for Detecting Tumor-Derived Cell Clusters
• NIH/NCI 458 - Microbiome-Based Tests for Cancer Research, Diagnosis, Prognosis and/or Patient Management
• NIH/NCI 459 - Automated Software for Point-of-Care Testing to Identify Cancer-Associated Malnutrition
• NIH/NCI 460 - Evaluation Datasets as Medical Device Development Tools for Testing Cancer Technologies
• NIH/NCI 461 - Ultra-Fast Dose Rate (FLASH) Radiation Detectors and Safety Systems for Cancer Treatment
• NIH/NCI 462 - Organ-on-Chip for Preclinical and Translational Radiobiological Studies
• NIH/NCI 463 - Translation of Novel Cancer-specific Imaging Agents and Techniques to Mediate Successful Image-guided Cancer Interventions
• NIH/NCI 464 - Cloud-Based Multimodal Data Analysis Software for the Cancer Research Data Commons
• NIH/NCI 465 - Cancer Prevention and Treatment Clinical Trials Tools for Recruitment and Retention of Diverse Populations

The deadline for submission is November 14 at 5:00PM ET.

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.

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