July 24, 2024

On Monday, PsychoGenics hosted a BioNJ roundtable discussion with Patient advocates and policymakers focused on opportunities for New Jersey to support increased Patient access to new and emerging medications — as well as opportunities to support the early-stage innovation that produces novel therapeutics. Representatives from a variety of mental health and rare disease Patient advocacy organizations joined the discussion, including several members of the recently-appointed New Jersey Rare Disease Advisory Council.

Photo from left to right: Dr. Ian McLaughlin, VP, Government Affairs, BioNJ; Patricia Geurds, Rare Action Network, NORD; Dr. Debra Wentz, President & CEO, NJAMHAA; Dr. Howard Fillit, CEO, Alzheimer’s Drug Discovery Foundation; Julie Raskin, CEO, Congenital Hyperinsulinism International; Dr. Emer Leahy, President & CEO, PsychoGenics & BioNJ Chair; Asw. Shama Haider (LD37); Asw. Lisa Swain (LD38); Asm. Chris Tully (LD38); Debbie Hart, President & CEO, BioNJ; Allan Malievsky, Sr. Director, External Affairs, atai Life Sciences; and Dr. Martina Flammer, Chair, NJ Rare Disease Advisory Council & Chief Medical Officer, Insmed. Missing from the photo are Assemblyman Chris DePhillips (D-40) and Dr. Kenneth Sonnenfeld, Board Member, Brain and Behavior Research Foundation who also participated.

BioNJ looks forward to continuing to facilitate conversations and connections between Patients, policymakers, and life sciences companies to ensure that we continue pursuing the kinds of policies that will ensure that New Jersey remains the Medicine Chest of the World.

Councilwoman McIver, who serves as the Newark City Council President, won the special Democratic Primary for NJ-10 that had long been represented by the late Rep. Donald Payne Jr. The special primary, which was called by Governor Murphy to fill the remainder of Rep. Payne Jr’s current term, included 11 Democratic candidates. Councilwoman McIver won the election with 47.7% of the vote.

Additionally, following the special primary, McIver was chosen at a Democratic county convention last week to be the Party’s nominee for the general election in November as well. The committee members from Essex, Union, and Hudson Counties provided McIver 79% of the vote, determining that she will face Carmen Bucco, the Republican candidate in November.

The next step in this process will be a vote on September 18th where voters will determine who will ultimately fill the remainder of Rep. Payne Jr.’s current term, an election that Councilwoman McIver is widely expected to win.

On Monday evening, LeRoy Jones, Jr., the New Jersey Democratic State Committee Chair, announced that the State’s Democratic Party has voted to endorse Vice President Kamala Harris for President.

To read the Party’s statement and coverage of the endorsement in Insider NJ, click here.

Yesterday, the House Committee on Oversight & Accountability held a hearing entitled “The Role of Pharmacy Benefit Managers in Prescription Drug Markets Part III: Transparency and Accountability.” Executives from the three largest PBMs, including Express Scripts, CVS Caremark, and CVS Health — which handle approximately 80% of all prescriptions written in the United States — testified before the Committee, and a bipartisan group of legislators highlighted the role that this industry has played in driving up costs. Comments included examples of tremendous markups, including a “38,000% markup” on a medication used to treat multiple sclerosis by CVS Caremark, noted by Rep. Jake Auchincloss (D-MA).

This hearing coincided with CVS Caremark agreeing to pay at least $45 million to the State of Illinois to settle allegations that rebates failed to be passed through to Patients during a four-year period. 

To watch the hearing, click here.

For reporting on the CVS Caremark settlement in STAT, click here.

Last week, Senator Menendez, along with two businessmen, were found guilty on all 16 counts on charges of accepting bribes connected to the benefit of the Egyptian and Qatari governments. A third businessman pled guilty and testified during the Senator’s trial. The jury deliberated for 12 hours over three days before returning their verdicts.

Senator Menendez maintains that he has never violated his public oath and has conveyed the expectation that he will be successful upon appeal. The Senator will be sentenced on October 29^th. Representative Andy Kim (D, NJ-3) won the primary to run for the seat that Senator Menendez currently occupies, and Senator Menendez has filed to run as an Independent in November’s general election.

Yesterday, the NJ Globe reported that the Senator will resign his seat effective August 20. Accordingly, Governor Murphy will need to appoint a replacement to serve as Senator for the remainder of Senator Menendez’s term. Given that the Senate is scheduled to be on recess from the beginning of August until the beginning of September, the Governor has a few weeks to determine his selection.

This past week, Senate President Scutari (D, LD22), Assembly Speaker Coughlin (D, LD19), Senator Gopal (D, LD11), Senate Health, Human Services and Senior Citizens Chair Vitale (D, LD19), Assembly Health Committee Chair Conaway (D, LD7), and Senators Greenstein (D, LD14), Mukherji (D, LD32) and Singleton (D, LD7) all joined together to address the role that pharmacy benefit managers (PBMs) play in driving the escalating drug costs that Patients confront. Assemblywomen Donlon and Peterpaul (D, LD11) joined in commenting on the issue as well:

“We are proud to convene members of State Senate and Assembly leadership to take a comprehensive look at the status of PBMs and how they impact consumers, employers and independent pharmacists. The role of PBMs is to be an intermediary between pharmacists, employers and insurers to ensure the most cost-effective medication routes. If state health benefits programs and Medicaid are being taken advantage of by PBMs or given increasingly high premiums, as alleged by the New York Times investigation, those costs are footed by taxpayers for private gain. There is an urgent need to address the impact of PBMs on the current market. We are committed to working together in the legislature to protect the well-being of consumers, employers, and independent pharmacists” — Senator Gopal, Assemblywoman Donlon, and Assemblywoman Peterpaul (D, LD11).

BioNJ is pleased to see increased attention and scrutiny directed towards the role that PBMs play in driving the escalating costs that patients confront — as well as the role that they play in diminishing the ability of a variety of pharmacies to operate — and we look forward to continuing to work with policymakers to make progress towards greater affordability and patient access.

For more coverage and statements from policymakers, click here.

Last week, the U.S. Patent and Trademark Office (USPTO) released guidance and three examples of how they are addressing innovation in emerging technologies, including artificial intelligence (AI). The update provides additional clarity on how the USPTO will evaluate subject matter eligibility claims involving applications and patents that involve AI.

To read the USPTO’s new guidance, click here.

Earlier this month, a research article was published that explores the role that mergers & acquisitions (M&A) plays in supporting biopharmaceutical innovation. In short, the article demonstrates that M&A enables the achievement of economies of scale and scope, the combination of complementary assets, attracts investment and funding innovation and incentivizes R&D and scientific risk-taking.

To read a summary of the article and access the article, click here.

Earlier this summer, the Berkeley Research Group (BRG) published an assessment of the scale of the federal 340B program, which was initially intended to ensure that Patients with limited resources and safety net hospitals will have access to the medications that they need, and finds that it continues to experience disproportionate growth and utilization well beyond its initial intention.

“In 2022, total 340B program sales reached $54.6 billion when measured at the discounted 340B price. This figure represents enormous growth — more than double the level of 340B sales compared to just five years prior. However, the figure does not adequately represent the true size of the 340B program, as on average 340B prices were 57% lower than list prices in 2022, and the discounted 340B price for some medicines is just a penny. Expressed in terms of the undiscounted list price, measured as the wholesale acquisition cost, 340B sales reached $126.3 billion in 2022.”

To read the analysis by BRG, click here.

The Pharmaceutical Research and Manufacturers of America released a new campaign focused on highlighting the ways that pharmacy benefit managers (PBMs) play in driving up the costs that Patients confront.

For a summary of the campaign, click here.

For a video from the campaign, 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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