On December 16, BioNJ’s Public Policy Committee met with Tim Lydon, the returning Executive Director of the Senate Majority Office. Having been the leader of the SMO under different Senate Presidents and Governors, Executive Director Lydon provided a unique perspective on the status of the Legislature, thoughts regarding the end of 2022 and expected priorities heading into 2023. As achieving greater affordability throughout the State remains a priority among legislative leadership, BioNJ looks forward to continuing to work with policymakers and regulators to identify opportunities to bring this goal to fruition.

Congress released the omnibus spending bill on Tuesday morning. While we continue to explore the bill’s language for highlights, the Senate began to debate the bill with the expectation that it will pass both chambers — avoiding a government shutdown at midnight on Friday.

Among the bill’s provisions are reforms to the Accelerated Approval (AA) pathway, requiring the FDA to define conditions for post-approval studies of AA drugs, including the target date for study completion, by the time the drug is approved. The FDA would be authorized to require that post-approval studies be underway at the time of approval or within a specified period following approval — and the FDA would be enabled to waive these requirements, contingent upon an explanation provided by the FDA. Additional provisions include expedited procedures for withdrawing an AA while enabling sponsors to request that an advisory committee to review the withdrawal. Sponsors will be required to submit a report of the progress of any confirmatory study — including progress toward enrollment targets, milestones and other required information — every six months following approval. The Secretary of HHS will also establish an intra-agency coordinating council in the FDA focused on consistent and appropriate use of the AA pathway.

The omnibus includes provisions that further affect FDA policy, several of which focus on clinical trial diversity. This language includes a requirement that sponsors implement a diversity action plan for Phase III trials, with certain exceptions to this requirement incorporated. The FDA will produce updated guidance on the form and content of diversity action plans with more granular demographic categories, as well as report diversity action plans to Congress.

Further, the FDA will issue draft guidance addressing decentralized clinical studies, including engagement, enrollment and retention of diverse participant demographics. Finally, the FDA will issue guidance on the modernization of clinical trials, focusing on digital health technologies, decentralized clinical trials and other innovative clinical trial designs to support expedited development and review.

There will also be a platform technology designation at the FDA associated with the development of new treatments that use technologies that can be integrated into more than one drug or biological product.

The omnibus also includes language that focuses on antimicrobial resistance (AMR). While it fails to include the broad framework provided by the PASTEUR Act, the bill will provide for biological products to qualify as Qualified Infectious Disease Products (QIDP). The language also provides for priority review of innovative biological antifungals upon demonstration of safety or effectiveness without extending QIDP exclusivity to biological products. Finally, the bill will direct the CDC to use existing resources to monitor AMR.

Among provisions focused on rare diseases, there will be an endpoint advancement pilot program to facilitate increased interaction with sponsors of rare disease drug development along with a reauthorization of grants devoted to the development of treatments for rare diseases.

The language does not include provisions enabling R&D amortization. The bill also excludes the Advanced Research projects Agency for Health (ARPA-H) from being located at the NIH, and the Director will identify at least 3 locations that facilitate the advancement of the goals of the Agency.

BioNJ will continue to explore the expansive bill and provide updates as highlights are identified.

On December 16, the U.S. Trade Representative (USTR), Katherine Tai, sent a letter to the U.S. International Trade Commission (USITC) to request an investigation and public report of available data that characterize access to COVID-19 diagnostics and therapeutics.

The USTR requested that the Commission solicit public comments, hold a hearing and encourage foreign governments, health advocates and manufacturers to participate. There are no policy conclusions intended from this activity. The report is requested by October 17, 2023.

BioNJ will continue to seize opportunities to convey the ramifications that this expansion would have on the work of a wide variety of life sciences companies moving forward. For additional details on the intended content and scope of the USITC investigation, click here.

Given the continued interest in improving affordability for both the residents and businesses throughout New Jersey, we were pleased to see that S2707 (Greenstein/Testa) was heard in the Senate Commerce Committee (SCM) on Monday. In short, this bill will increase the qualified research expenses tax credit, as well as the basic research payments tax credit, from 10% to 15% — and render the tax credit refundable.

BioNJ submitted support for the bill and will continue to advocate on behalf of this and similar approaches to achieving greater affordability, as well as increased incentives in R&D investment in the life sciences, throughout New Jersey.

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.