BioNJ would like to congratulate the members of the House from the State of New Jersey for their respective elections in last Tuesday’s election. As the medicine chest of the world, the biopharmaceutical industry in New Jersey has played a pivotal role in accelerating and promoting biomedical innovation that has not only provided crucial medicines to Patients who need them world-wide — but also contributed tremendously to the State’s communities and economy. BioNJ is grateful to have the privilege of representing the industry at both the State and national levels, and we very much look forward to continuing to work with the New Jersey delegation to find opportunities to support the innovation of companies in the life sciences, avoid policies that inhibit this work and ensure that Patients have the treatments that they need when they need them.

As we all know, last Tuesday was Election Day throughout the country — and all 12 members of the New Jersey House delegation were up for election. In short, there are only two New Jersey House seats that will no longer be occupied by their incumbents. District 7 will flip from being held by Tom Malinowski (D) to Tom Kean Jr. (R), and District 8 will be occupied by Robert Menendez, Jr, a Democrat and son of Senator Bob Menendez.

Please see below for a more detailed breakdown of each election (winner listed first, *=incumbents):

• District 1: Donald Norcross* (D, 62.2%) vs. Claire Gustafson (R, 35.4%)
• District 2: Jeff Van Drew* (R, 59.3%) vs. Tim Alexander (39.6%)
• District 3: Andy Kim* (D, 55%) vs. Bob Healey (R, 44.1%)
• District 4: Chris Smith* (R, 67.1%) vs. Matthew Jenkins (D, 31.2%)
• District 5: Josh Gottheimer* (D, 54.4%) vs. Frank Pallotta (R, 44.7%)
• District 6: Frank Pallone* (D, 57.1%) vs. Susan Kiley (R, 41.4%)
• District 7: Tom Kean Jr. (R, 52.1%) vs. Tom Malinowski* (D, 47.9%)
• District 8: Robert Menendez Jr. (D, 73.3%) vs. Marcos Arroyo (R, 23.8%)
• District 9: Bill Pascrell* (D, 54.4%) vs. Billy Prempeh (R, 44.2%)
• District 10: Donald Payne Jr.* (D, 77.2%) vs. David Pinckney (R, 20.5%)
• District 11: Mikie Sherrill* (D, 58.1%) vs. Paul DeGroot (R, 41.1%)
• District 12: Bonnie Watson Coleman* (D, 60.2%) vs. Darius Mayfield (R, 38.8%)

Nationally, while the Republican Party was expected to make very significant gains in the House by election forecasters, it appears that they may take the House majority with a slim margin. However, there are still about 18 races yet to be called which will determine whether the Republicans will take the majority in the House.

In the Senate, with John Fetterman flipping a Pennsylvania Senate seat from Republican to Democratic control, along with Senators Mark Kelly in Arizona and Catherine Cortez Masto winning reelection over the weekend, the Democrats will retain control of the upper chamber. The size of the Democratic majority in the Senate will be determined by a run-off election in Georgia on December 6, making for what is likely to be a split federal legislature, with the Republicans having the majority in the House and Democrats in the Senate.

Several companies have decided to modify their therapeutic development strategies as a function of the drug pricing provisions in the Inflation Reduction Act signed into law earlier this year. Eli Lilly has removed a Phase 1 drug, a BCL2 inhibitor, as it would no longer satisfy thresholds for continued investment following the signing of the IRA. Similarly, Alnylam ended Phase III intentions for vutrisiran, developed to treat the rare Stargardt disease.

Finally, Amgen explicitly noted the role that the drug pricing provisions in the IRA are playing in their strategy, stating “The IRA’s drug pricing controls and Medicare redesign is likely to have a material adverse effect on our sales (particularly for our products that are more substantially reliant on Medicare reimbursement), our business and our results of operations.”

These decisions and deliberations reflect those of other companies as well, including AbbVie, Amgen, GSK and Roche. BioNJ will continue to engage policymakers at both State and federal levels to emphasize the ramifications of these provisions on biomedical innovation, the invention of new and more effective therapeutics and Patient access to the medications that they need.

On November 1, Massachusetts Governor Charlie Baker signed H.4929, which will regulate the ability for insurers to implement step therapy practices. Step therapy, also called “fail first”, is a procedure by which insurance companies require covered individuals to be treated with a pre-determined prescription, and to fail on that treatment, prior to having another prescription prescribed and covered under their plan — irrespective of the prescribing decisions that physicians and Patients have made together. It can include lengthy deliberations that delay Patient access to medications prescribed by their physicians.

The Massachusetts legislation will require insurers to either approve or deny step therapy exemption requests within 3 business days, or 24 hours in emergency conditions, resulting in more efficient and rapid access to prescribed medications. This will count Massachusetts among the majority of U.S. States that have some form of regulation applied to step therapy and prior authorization.

While there are debates regarding legal semantics, and despite past efforts to curtail step therapy through policy, New Jersey continues to be among the remaining handful of States that have no substantial regulatory limitations on the implementation of step therapy. Accordingly, BioNJ has joined with coalition partners to advocate on behalf of A1255 (Stanley/Conaway/Benson) — "Ensuring Transparency in Prior Authorization Act." The bill has made progress in both the State Senate and Assembly, and was most recently pulled from an agenda in the Assembly Financial Institutions and Insurance Committee (AFI) on September 15.

BioNJ will continue to work with our coalition partners to advocate on behalf of the passage of this important legislation to ensure that Patients have access to the medications that they and their physicians decide are best for them as rapidly and efficiently as possible.

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.  

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