Statement Regarding Ruling on FDA Regulatory Authority by
Federal Judge
| |
On April 7, a federal district judge ruled that the Food and Drug Administration (FDA) improperly approved a medication over 20 years ago. Debbie Hart, President & CEO of BioNJ, has issued the following statement: | |
On the same day, a different federal district judge issued a contradictory ruling, resulting in what is expected to be a series of appeals that will escalate the issue to the Supreme Court. | |
Debbie Hart Delivers Testimony before the United States
International Trade Commission
| |
On March 30, Debbie Hart provided testimony in Washington, D.C. regarding the potential expansion of the TRIPS waiver to include diagnostics and therapeutics used for the treatment of COVID-19. The testimony emphasized the ramifications that the adoption of this expansion would have on the future of innovation in the life sciences both within New Jersey and nationally.
To read Hart’s full testimony, click here.
| | |
Opportunity to Submit Comments to CMS Regarding Implementation of the Inflation Reduction Act Before the April 14 Deadline | |
On March 15, the Centers for Medicare and Medicaid Services issued guidance for the provisions in the Inflation Reduction Act (IRA) that provide for the ability of the agency to negotiate and set prices for certain medications. The guidance includes a 30-day comment request which concludes on April 14.
Given the importance of conveying the concerns that the industry has had regarding how this legislation will be implemented, and what appears to be a deficit in understanding regarding how the life sciences industry operates, BioNJ is joining in signing on to comments that will be submitted by the Biotechnology Innovation Organization (BIO).
Additionally, Patient advocacy groups are contributing their voices to emphasize that the implications of misguided and imprudent policies associated with the legislation extend beyond solely the life sciences industry. For example, the Partnership to Fight Chronic Disease is collecting signatures to a draft of a letter to be submitted regarding the detrimental effects that certain approaches to implementation may have for the Patient community.
-To view the comment request and submit comments to CMS, click here.
-To view and sign the letter from the Partnership to Fight Chronic Disease, click here.
-To view and sign a letter regarding ensuring that value assessments are Patient-focused from the Partnership to Improve Patient Care, click here.
-To view and sign a letter focused on effective implementation of policies associated with Maximum Fair Price determinations, emphasizing the need for a consistent retrospective model, click here.
| | |
BioNJ and Member Companies Meet with Members of Congress | |
On March 29, representatives from a diversity of biopharmaceutical companies joined BioNJ in a series of meetings with members of the New Jersey Congressional delegation and their staffers in Washington, D.C.
Topics of discussion focused on the challenges and opportunities that the life sciences sector faces both in New Jersey and nationally—including the economic and societal impact of the sector; health disparities and equitable access to clinical trials; importance of protecting the U.S. intellectual property legal framework to innovation and investment; the evolution of 340B; prior authorization and step therapy; Section 174; and ensuring that the implementation of the Inflation Reduction Act is executed in a way that minimizes the inhibition of innovation within the sector.
BioNJ appreciates the opportunity to discuss these important issues with policymakers from our State, as well as their receptivity to the perspectives of New Jersey’s life sciences sector. We look forward to collaborating with the State’s policymakers to ensure that New Jersey continues to be home to a thriving life sciences sector.
Below are photos from a selection of the meetings our group had with members of the New Jersey delegation:
| | |
Foreground: Senator Cory Booker; Debbie Hart President & CEO, BioNJ; Paul Howard, PhD, Senior Director, Public Policy, Amicus Therapeutics; Joe Zorzoli, Head, U.S. Government Affairs & Policy, Genmab Background: Wendy Lazarus, Principal, WML Public Affairs; Mike Adatto, Head, Market Access Business Unit, Ferring Pharmaceuticals; Tegan Gelfand, Director, Government Affairs, Federal & Head, Public Policy, Ferring Pharmaceuticals; Ian McLaughlin, Ph.D., Vice President, Government Affairs, BioNJ | | |
Left to right: Ian McLaughlin, Ph.D., Vice President, Government Affairs, BioNJ; Joe Zorzoli, Head, U.S. Government Affairs & Policy, Genmab; Paul Howard, Ph.D., Senior Director, Public Policy, Amicus Therapeutics; Debbie Hart, President & CEO, BioNJ; Representative Bill Pascrell (NJ-9); Tim Swope, Director, Pharmaceuticals, U.S. Federal Affairs, Johnson & Johnson; Tegan Gelfand, Director, Government Affairs, Federal & Head, Public Policy, Ferring Pharmaceuticals; Wendy Lazarus, Principal, WML Public Affairs; Mike Adatto, Head, Market Access Business Unit, Ferring Pharmaceuticals | | |
Left to right: Jenny Nieto, Senior Director, Government Affairs & Policy, Gilead Sciences; Tegan Gelfand, Director, Government Affairs, Federal & Head, Public Policy, Ferring Pharmaceuticals; Representative Josh Gottheimer (NJ-5); Debbie Hart, President & CEO, BioNJ; Ian McLaughlin, Ph.D., Vice President, Government Affairs, BioNJ; Wendy Lazarus, Principal, WML Public Affairs | | |
Left to right: Joe Zorzoli, Head, U.S. Government Affairs & Policy, Genmab; Mike Adatto, Head, Market Access Business Unit, Ferring Pharmaceuticals; Tegan Gelfand, Director, Government Affairs, Federal & Head, Public Policy, Ferring Pharmaceuticals; Debbie Hart, President & CEO, BioNJ; Representative Robert J. Menendez (NJ-8); Paul Howard, Ph.D., Senior Director, Public Policy, Amicus Therapeutics; Ian McLaughlin, Ph.D., Vice President, Government Affairs, BioNJ; Wendy Lazarus, Principal, WML Public Affairs | | |
New Jersey State Legislative Update
State Legislative Seat Changes Reach 26
| |
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
- Anette 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)
- Beth Sawyer (R, LD-3) – Running for Senate, LD-3
The State Legislature is currently holding hearings regarding the Governor’s proposed budget that will continue until late next month.
To view the Governor’s Budget in Brief, click here.
To view the Governor’s Detailed Budget, click here.
| | |
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.
| | |
Thank You to Our Public Policy Sponsors | | | | |