The Bipartisan PASTEUR Act, which would support the development of innovative antibiotics to treat resistant infections and improve appropriate antibiotic use, was introduced on April 27 by Senators Michael Bennet and Todd Young, accompanied by Representatives Scott Peters, Drew Ferguson, Mike Levin and Jake LaTurner. To read the announcement of the bill’s reintroduction by Senator Bennet, click here.

Additionally, the House Energy & Commerce Subcommittee on Oversight and Investigations held a hearing focused on antimicrobial resistance on April 28.

In response to the federal district court ruling in Texas regarding mifepristone, BioNJ has signed onto an amicus brief, and will sign onto any future related amicus brief, focused on the court’s “misunderstanding of the statutory and regulatory provisions governing drug approval; the substantial chilling effect its decision, if not stayed in its entirety, will have on drug development; and the widespread harm that will result to the industry and its investors, as well as to healthcare providers and their patients.” This follows BioNJ signing onto an open letter from leaders of the life sciences industry in support of the FDA’s authority in the days following the initial ruling.

To read the amicus brief, click here.

Last week, Senators Bernie Sanders and Bill Cassidy, the chair and ranking member of the Senate Health, Education, Labor and Pensions Committee (HELP), announced an agreement on a bipartisan package consisting of four bills focused on pharmacy benefit managers (PBMs) and access to generic medications.

Among other provisions and a variety of proposed amendments, the bill that focuses on PBM transparency (S.1339) would require the middlemen to pass 100% of rebates from manufacturers to the plans that employ them and ban spread pricing. This follows an announcement by Senators Ron Wyden and Mike Crapo, the chair and ranking member of the Senate Finance Committee, of a bipartisan framework for reducing drug costs by, in part, reforming PBM business practices. The Senate Finance Committee previously held a hearing focused on PBMs on March 30.

The Senate HELP Committee hosted a hearing on May 2 which was intended to include markup of S.1339 that ultimately concluded in adjournment and a delay of mark-up until the morning of May 11. This will be the day after a hearing scheduled for May 10 with a variety of witnesses from three large biopharmaceutical companies and the three largest PBMs (CVS, Express Scripts, and Optum).

The Committee still has a hearing scheduled on May 4 focused on reauthorization of the Pandemic and All-Hazards Preparedness Act (PAHPA). PAHPA is legislation devised to improve the country’s preparedness for public health threats.

These hearings and pieces of legislation are in addition to The PBM Sunshine and Accountability Act, H.R.2816, introduced in the House by Rep. Diana Harshbarger on April 25, which would mandate new public reporting requirements by the middlemen.

A letter addressed to Administrator Chiquita Brooks-LaSure by Senator Mike Crapo and Representatives Cathy McMorris Rodgers and Jason Smith was sent regarding concerns resulting from the guidance for the drug price negotiation provisions in the Inflation Reduction Act released by CMS. The letter notes that this guidance “exacerbates the law’s statutory flaws and compounds the profound uncertainty and risk posed by the legislation’s sweeping drug price controls.”

On April 26, the House Energy and Commerce Subcommittee on Health held an expansive hearing entitled “Lowering Unaffordable Costs: Legislative Solutions to Increase Transparency and Competition in Health Care.” The future of accelerated approval was discussed following remarks from CMS Administrator, Chiquita Brooks-LaSure, indicating an expectation that the agency will continue to cover therapeutics approved via the pathway despite prior CMS determinations. Ranking member Rep. Anna Eshoo, noted bipartisan concerns over prior CMS determinations regarding novel treatments for Alzheimer’s Disease that were approved via accelerated approval, conveying deep concerns communicated to her office by constituents confronting the condition.

On April 26, Senators Kirsten Gillibrand and Mike Braun, along with Representatives Mike Gallagher and Mike Quigley, reintroduced legislation that would provide for an accelerated provisional FDA approval pathway for therapeutics that would treat diseases that are characterized by rapid pathological progression for which few or no treatment alternatives exist.

For an announcement by Senator Gillibrand, click here.

On April 27, the House Subcommittee on Courts, Intellectual Property and the Internet held an oversight hearing that included USPTO Director and Under Secretary of Commerce for Intellectual Property, Kathi Vidal. During the hearing, Director Vidal noted that the agency “will continue to drive innovation without discouraging the competition that allows family farmers to thrive and does not unnecessarily delay lower-cost medications needed by many.” She further articulated that the agency has received comments on “how we can issue more robust and reliable intellectual property protections that will attract investments and grow jobs.”

This followed the release of an annual report by the U.S. Trade Representative (USTR) on April 26, determining that improvements to global intellectual property protections that are crucial to innovation remain to be made. In response to the report, the Biotechnology Innovation Organization (BIO) noted that, while several suggestions provided by the organization were incorporated by the USTR, the report signals the contradictory possibility of U.S. support for an expansion to the TRIPS waiver by the World Trade Organization (WTO).

BioNJ looks forward to continuing to engage the federal government regarding the potential TRIPS waiver expansion and the importance of a predictable, reliable and strong intellectual property framework to innovation in the life sciences.

The deadline for final written submissions for the USITC’s investigation, COVID-19 Diagnostics and Therapeutics: Supply, Demand, and TRIPS Agreement Flexibilities (Inv. No. 332-596), is this Friday, May 5. Debbie Hart, President & CEO of BioNJ, previously delivered oral testimony and a post-hearing brief articulating the importance of intellectual property protections to innovation in the life sciences industry — both in New Jersey and nationwide.

In addition to the testimony and materials submitted to the USITC, BioNJ will continue engaging policymakers at both the State and federal levels to convey the significance of this potential policy decision to the future of the life sciences industry in New Jersey and nationwide.

To read the request letter addressed to the USITC from the U.S. Trade Representative, click here.

To view all materials submitted to the USITC for this investigation, as well as submit materials to the Commission regarding the potential TRIPS waiver expansion prior to the May 5 deadline, register and create an account on the Commission’s Electronic Document Information System (EDIS) here. Search for the investigation number 332-596.

The New Jersey Senate and Assembly will continue to have their respective budget hearings through the end of May, including a Senate Budget and Appropriations hearing with the Department of Health on May 4 followed by the Committee’s hearing with the Department of Banking & Insurance on May 16.

There are several deadlines for New Jersey elections that are approaching:

• May 8: Non-budget committees and voting sessions resume
• May 16: Voter registration deadline
• May 30: Deadline to apply for a mail-in ballot for the primary election
• June 2-June 4: Early voting period
• June 5 by 3:00PM: Deadline for in-person mail-in ballot applications for the primary election
• June 6: Primary election day

For additional information on voting in the upcoming primary, you can find information here: https://www.nj.gov/state/elections/vote.shtml

There are opportunities at both the State and federal levels to address changes to Section 174 of the Internal Revenue Code that were implemented by the Tax Cuts and Jobs Act of 2017 (TCJA). Prior to the TCJA, Section 174 allowed taxpayers to choose whether to deduct research or experimental (R&E) expenditures in the year in which they were incurred — or capitalize and amortize. Following the TCJA, businesses must capitalize and amortize these expenses over a period of five years. This can result in a substantial increase in taxes that can become untenable for a variety of companies in the life sciences.

At the federal level, S.866 and H.R.2673 have been introduced by Senator Maggie Hassan and Representative Ron Estes, respectively. As we did during our meetings with legislators in D.C. last month, BioNJ will continue to convey the importance of addressing these recent changes to the tax code to the New Jersey congressional delegation.

At the State level, S3737/A5323 was introduced in March by Senator Paul Sarlo and Assemblywoman Eliana Pintor Marin, which would, among other provisions, allow for the deduction of R&D expenses in 2022 and the subsequent years in which they are incurred.

BioNJ will continue to engage policymakers at the State level to convey remaining concerns and opportunities to more effectively address issues derived from changes at the federal level to ensure New Jersey remains home to a thriving life sciences sector.

BioNJ joined a coalition of organizations in New Jersey, Pennsylvania and Delaware in a proposal submitted for a Greater Philadelphia Customer Experience Hub to be one of the three that will constitute the Advanced Research Projects Agency for Health (ARPA-H). ARPA-H is a research funding agency focused on breakthroughs in research spanning the entire biomedical landscape, from “the molecular to the societal.” The consortium would be led by the University City Science Center and would comprise a diverse “network of networks” that includes entities in academia, biopharma, governors and government agencies from all three states, health care and trade organizations—including our partner affiliates in DE and PA.

For further information and discussion, as well as a copy of the white paper that was submitted, please contact Ian McLaughlin, VP of Government Affairs at BioNJ: IMcLaughlin@BioNJ.org.

BioNJ released a whitepaper entitled “Health Equity in Clinical Trials MBA Business Case Competition: Identifying Innovative Approaches to Strengthening Diversity Within Clinical Trials” during the BioNJ BioPartnering Conference on April 18. The whitepaper includes a description of BioNJ’s Health Equity in Clinical Trials MBA Business Plan Case Competition and has been widely circulated.

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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