BioNJ Mourns the Loss of New Jersey Assemblyman Dancer |
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Assemblyman Ronald Dancer, who represented New Jersey’s 12th Legislative District, passed away on July 23, 2022 at the age of 73. A veteran and former Mayor of Plumsted, Assemblyman Dancer served in the General Assembly beginning in 2002. Assemblyman Dancer was known for his integrity and willingness to collaborate with members of the State’s Assembly and Senate on substantive legislation in a truly bipartisan fashion. In addition, he served as a member of the Board of Social Services, the Natural Land Trust Fund Advisory Committee, the Senior Citizens Advisory Board and the Human Services Advisory Council in Ocean County. Governor Murphy, Assembly Speaker Coughlin, Assembly Minority Leader DiMaio and State Senator Bramnick have all commented on the impact that Assemblyman Dancer has had throughout the State and how he will be honored and remembered.
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Update on Build Back Better Drug Pricing Provisions |
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The Senate Parliamentarian is currently reviewing whether a diminished version of the Build Back Better package will be viable for the budget reconciliation process, which requires only a simple majority vote, but must have some direct budgetary relevance. Due to concerns over the broader Build Back Better package from Senator Manchin (D-WV) regarding language focused on climate and tax reform, the broader legislation was diminished to focus specifically on drug pricing.
BioNJ continues to engage in outreach campaigns to our Members of Congress to convey concerns regarding the ramifications that this legislation would have on innovation, Patient access to medications and the broader biopharmaceutical landscape.
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BioNJ released the following statement in response to these provisions:
“The drug pricing legislation being considered by Congress to address prescription drug costs is misguided and will ultimately harm medical innovation and Patients,” said Debbie Hart, President and CEO of BioNJ. Government price-setting polices will threaten Patient access and future innovations. Congress should focus on policies that would actually support Patient access and reduce costs by focusing on the role of PBMs and all insurance middlemen who drive up drug prices and shift more of the cost burden to Patients.
"BioNJ stands ready to work with our Members of Congress on policy solutions that would positively impact Patient out-of-pocket costs. The proposed legislation would have a detrimental impact on future investment in research and innovation, with a disproportionate impact on the smaller biotechnology companies. With the COVID pandemic and other diseases, such as cancer and diabetes impacting the health of Patients, now is the time to strengthen the innovative biopharmaceutical ecosystem and combat health inequity, not harm it through price controls."
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Update on FDA User Fee Negotiations |
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On July 14, 2022, Senator Burr (R-NC) announced his opposition to the Senate version of the Food and Drug Administration (FDA) user fee reauthorization bill following the introduction of amendment language by other senators, emphasizing that the amendments would inhibit innovation within the industry. Without the reauthorization of policies under the Prescription Drug User Fee Act (PDUFA), the Generic Drug User Fee Act (GDUFA), the Biosimilar User Fee Act (BsUFA) and the Medical Device User Fee Amendments (MDUFA) by the beginning of August of this year, the FDA will be required to move towards the layoff of staff and closure of this work prior to the expiration of current authorizations on October 1, 2022.
The novel amendments in the Senate version would extend to reforming how the FDA regulates diagnostics, dietary supplements and cosmetics. In response to the introduction of these amendments, Senator Burr has proposed the passage of a "clean" reauthorization package, while the House has urged the passage of their legislation which does not include these Senate amendments.
Several outcomes remain possible. "Clean" user fee reauthorization language may be incorporated into the continuing resolution that Congress will likely pass prior to September 30 to avoid a lapse in appropriations, or government shutdown. Alternatively, the Senate may advance clean language, though this would eliminate amendments introduced by both Democrats and Republicans. FDA Commissioner Califf has publicly commented on how critical user fees are to the stability of the Administration, and how a failure to pass legislation would severely inhibit operations and significantly extend timelines, all at a time when they already struggle to achieve full staffing.
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Antimicrobial Resistance and the PASTEUR Act |
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On July 12, 2022, the CDC released a report demonstrating a significant reversal in the progress towards addressing antimicrobial resistance. Specifically, the CDC notes that the threat of antimicrobial-resistant infections has been exacerbated over the course of the COVID-19 pandemic, with resistant hospital-onset infections and fatalities both increasing by a minimum of 15% during the first year of the pandemic.
CQ Roll Call, in partnership with Pfizer, hosted a panel discussion on July 20, 2022, which included comments from Senators Young (R-Indiana) and Bennett (D-Colorado), along with physicians and scientists, regarding the importance of the "Pioneering Antimicrobial Subscriptions to End Upsurging Resistance Act”, or “PASTEUR” Act, in the fight against antimicrobial resistance. This bipartisan legislation aims to encourage the development of new therapeutics by establishing novel funding structures made available to the industry, including subscription contracts, grants and more sophisticated data tracking systems to improve surveillance of antimicrobial resistance. BioNJ supported an outreach campaign to federal legislators regarding the concern of antimicrobial resistance, contacting the full New Jersey delegation for a briefing on the topic.
The webinar can be viewed here.
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We Need Your Help: Support BioNJ Policy and Advocacy Efforts |
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BioNJ is the voice of New Jersey’s life sciences sector in Trenton and Washington. BioNJ’s Public Policy Support Series sponsorship opportunities are still available for 2022. Help ensure BioNJ continues to deliver our message of improved Patient access and enhanced innovation through a Public Policy Support Series Sponsorship.
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Thank You to Our Public Policy Sponsors |
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