January 11, 2023

Governor Murphy Delivers State of the State Address

On January 10, Governor Phil Murphy delivered this year’s State of the State address. In addition to describing sustained priorities focused on increasing affordability and opportunity throughout the State, the State’s life sciences ecosystem received recognition as a priority...

“We are reclaiming our historic standing as the Medicine Chest to the World, welcoming tomorrow’s leaders in the life sciences while keeping companies that have proudly called New Jersey home right here,” said Governor Murphy.

BioNJ looks forward to continuing to work with the Governor and Legislature and stand ready to provide a voice for the life sciences industry as this effort comes to fruition in 2023.

For the Governor’s full State of the State Address, click here.

Rep. Kevin McCarthy Elected Speaker

Following a protracted series of 15 votes, the longest in over 100 years, Congressman Kevin McCarthy was elected Speaker of the House on January 6 with a slim majority of 216 to 212 votes, including six Republican legislators voting “present”.

The new Congress met at the end of the day Monday to vote on a new rules package to establish the procedural framework that will determine how the House will operate for this Congress. Given the narrow majority in the House, the process was as contentious as anticipated. As a result of the negotiations required to secure U.S. Rep. McCarthy’s election as Speaker, the resulting rules package includes a diminution of the typical powers associated with the Speakership — including an ability of a single legislator to motion to vacate the chair, triggering a vote that could remove the Speaker, as opposed to the majority of legislators that was formerly required.

Moving forward, the narrow Republican majority in the House is expected to result in significant deadlock and an emphasis on oversight hearings and investigations in lieu of significant legislation.

The Office of Science & Technology Policy Requests for Information for the Biotechnology and Biomanufacturing Initiative

At the end of last December, the OSTP posted a few notices of requests for information (RFI). One is a broader effort to collect comments on how advances in biotechnology and biomanufacturing can help to achieve the goals described by President Biden for the Initiative. The second seeks comments that might include data, information and case studies to identify regulatory ambiguities, gaps, inefficiencies or uncertainties in the Coordinated Framework for the Regulation of Biotechnology — with an emphasis on new and emerging biotechnology products.

BioNJ would invite and appreciate any input from all sources that may be relevant to the RFIs to help convey insights regarding the initiative to the OSTP.

If anyone would like to discuss these requests further, please email Ian McLaughlin, VP of Government Affairs, BioNJ at IMcLaughlin@BioNJ.org

The United States Patent and Trademark Office Seeks Public Comments on 2022-2026 Strategic Plan

The USPTO announced that the Office is seeking public comments on its draft 2022-2026 Strategic Plan. Given the stated goals of the Office to drive inclusive U.S. innovation and global competitiveness, promote the protection of IP against new and persistent threats and bring innovation to positive impact, the Office would benefit from insights derived from entities in the life sciences.

Comments can be provided to the USPTO via email by January 31, 2023 to: strategicplan@uspto.gov

BioNJ Survey on the Ramifications of the Inflation Reduction Act

Last week, BioNJ shared a survey with Member companies with the goal of understanding how the implementation of the IRA has affected what, if any, critical decisions organizations have made — or anticipate making — following the signing of the legislation. We understand that many companies have modified their development strategies, and it will be critical to convey the implications of this legislation as accurately and comprehensively as possible as we continue to engage policymakers.

Please click here to take the survey.

U.S. Securities and Exchange Commission Adopts Amendments to Modernize 10b5-1

Following advocacy from a variety of entities, including BioNJ, the SEC has adopted changes to the 10b5-1 regulations to avoid unforeseen consequences as a byproduct of its proposed changes. BioNJ, with help from Member companies, engaged the Commission in March of last year to convey issues with the initial plans to reform the regulation and has incorporated nearly all of the suggested changes. We are grateful for both the partnership with Member companies, as well as the receptivity of the Commission to substantive insights from the life sciences industry, on this important issue. We look forward to continued collaboration moving forward.

Editorial Discusses the True Implications of the Provisions of the Inflation Reduction Act

Former New Jersey State legislator and Chief of Staff to Governor Chris Christie, Rich Bagger, authored an editorial that addresses many of the broad misconceptions regarding the provisions of the IRA — and particularly misconceptions arising from the ramifications of its provisions for investment, R&D and overall Patient access to therapeutics.

In addition to acknowledging the diminished indications for approved medicines and investment in small molecule R&D as consequences of the IRA, the piece emphasizes the missed opportunities to truly achieve greater affordability, including the complete absence of any provisions that would render the business practices of Pharmacy Benefit Managers (PBMs) less predatory.

We Need Your Help: Support BioNJ Policy and Advocacy Efforts

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.

We hope 2023 is off to a productive start for everyone and look forward to keeping you up to date on policy developments at the State and federal levels.

Thank You to Our Public Policy Sponsors

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