The Council of State Bioscience Associations (CSBA) is convening in Washington, D.C. today and tomorrow to meet with legislators representing constituents across the country. BioNJ looks forward to meeting with the New Jersey delegation to discuss the challenges and opportunities that face organizations in the life sciences, as well as the near- and long-term implications of recent legislation, including the Inflation Reduction Act.

With the addition of Assembly members Gove, Mosquera and Giblin — along with the potential for even more changes to the compositions of both houses — the next legislative session will see a tremendous number of new members.

Senate

• Jean Stanfield (R, LD-8)
• Christopher Connors (R, LD-9)
• Steve Oroho (R, LD-24)
• Nicholas Sacco (D-32)
• Sam Thompson (R/D, LD-12)
• Sandra Cunningham (D, LD-31)
• Fred Madden (D, LD-4)

Assembly

• Gabriela Mosquera (D, LD-4)
• DiAnne Gove (R, LD-9)
• John Catalano (R, LD-10)
• Dan Benson (D, LD-14)
• Sadaf Jaffer (D, LD-16)
• Parker Space (R, LD-24) – Running for Senate, LD-24
• Hal Wirths (R, LD-24)
• Mila Jasey (D, LD-27)
• Ralph Caputo (D, LD-28)
• Angela McKnight (D, LD-31) – Running for Senate, LD-31
• Pedro Mejia (D, LD-32)
• Angelica Jimenez (D, LD-32)
• Raj Mukherji (D, LD-33) – Running for Senate, LD-32
• Annette Chaparro (D, LD-33)
• Britnee Timberlake (D, LD-34) – Running for Senate, LD-34
• Thomas Giblin (D, LD-34)
• DeAnne DeFuccio (R, LD-39)
• Kevin Rooney (R, LD-40)

A bill focused on altering corporate tax policy in New Jersey was introduced:

• S3737 (Sarlo) | A5323 (Pintor Marin) - Revises various provisions concerning State tax law.

The bill would address research and experimental cost amortization, the tax treatment of global intangible low-taxed income (GILTI) and foreign-derived intangible income (FDII). A hearing is planned and BioNJ will provide updates as the bill moves through the legislative process.

Following the submission of a petition sent to Secretary of Health and Human Services Xavier Becerra to exercise march-in authority in pursuit of lower cost of a particular medication, the NIH has declined to do so. As articulated in a letter from HHS, the Department determined that the medication is widely available to the public and that the NIH does not anticipate that the use of march-in authorities would effectively lower the cost of the medication.

The Bayh-Dole Act refers to federal legislation adopted in 1980 that modified the processes by which federal contractors who acquire ownership of inventions that arose from research that received federal funding. Ultimately, it enables contractors to retain ownership of those inventions. The Bayh-Dole act has been credited with helping to dramatically increase innovation in the life sciences. Prior to the legislation, not a single drug discovered with the aid of federal funding made it all the way to market — and there have been over 300 that have done so since the adoption of the legislation.

However, on March 21, 2023, both HHS and the Department of Commerce announced the intention to conduct a “whole-of-government” approach to reviewing march-in authorities. This Interagency Working Group for Bayh-Dole intends to develop a framework for the implementation of march-in authorities to more explicitly define the criteria that guide determinations, incorporating factors like price, when conducting these assessments.

BioNJ is pleased that the Department has upheld the law, given that march-in authorities were only intended to remedy circumstances where an enterprise does not make a good-faith effort to develop a particular product. The potential ramifications of such an inappropriate expansion of this provision were substantial, including a likely significant diminution of collaboration between the public and private sectors — and an inhibition of innovation in the life sciences as a consequence. We will continue to advocate on behalf of the appropriate application of this authority, as well as the salutary effects that the Bayh-Dole Act has had on the innovation that yields new and more effective treatments and cures on which Patients rely.

On March 15, 2023, the Centers for Medicare and Medicaid Services released guidance on how negotiations between companies and the federal government will proceed beginning in 2026. The guidance includes the requirements for the manufacturers of both Medicare Part D and B drugs, how CMS plans on setting initial negotiated prices, as well as exclusion criteria for a range of products. CMS is soliciting feedback prior to April 14 on these provisions.

BioNJ will continue to seek opportunities to engage regulators on the implementation of the Inflation Reduction Act to mitigate the inhibitory effects on innovation in the life sciences.

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.