BioNJ Statements

“BioNJ is deeply concerned about the 100% tariffs on drugs announced by the Administration which will go into effect this Wednesday, October 1, 2025. These proposed tariffs have the potential to increase manufacturing costs, disrupt supply chains, slow research and development timelines and ultimately hurt Patient access to essential medicines at a time when affordability remains a major concern in the U.S. healthcare system.  As the organization in New Jersey that represents the full continuum of biopharmaceutical companies including the most frangible early-stage companies, BioNJ urges all policymakers to do all within their power to protect innovation and the investments that all of our companies are making in innovation and Patients. Because Patients Can’t Wait®.”

“The centrality of the life sciences sector to both the U.S. economy and the nation’s national security, and the importance of onshoring manufacturing in the sector, has been contemplated by multiple presidential administrations. Over the past several years, BioNJ Member companies have conveyed that we all share the goal of ensuring the U.S. life sciences ecosystem is as innovative and durable as possible for decades to come.

“Focusing on this fundamental mission will both accomplish those economic and security goals — and ultimately redound to the benefit of American life sciences companies and the global Patient community whose wellbeing is at the core of the work that we all do. This is why numerous BioNJ Member companies have already demonstrated their willingness and intention to begin putting shovels in the ground to expand manufacturing in the United States.

“However, despite sharing these goals, not every biopharmaceutical company is capable of doing so on such short timelines. In particular, many small- and medium-sized biotech companies are still in the process of plotting out how they will restructure their manufacturing relationships and rely upon partnerships for manufacturing. This has been a strength of American biotechnology and has enabled the U.S. to lead the world in biomedical innovation — and it will take time to transition in a way that sustains that dominance.

“To successfully accomplish this goal, the U.S. government needs to work in tandem with the whole of BioNJ’s membership — including both small- and medium-sized biotechnology companies along with the nation’s larger biopharmaceutical companies. The pursuit of this goal, and achieving success in accomplishing this mission, requires that we avoid unintended collateral damage of undermining the nation’s status as the premier source of biomedical innovation globally by moving with excessive haste.

“Due to the magnitude of investment, the long timelines associated with R&D, and the uniquely high level of expertise needed in our sector’s manufacturing, companies need time to effectively reorient their strategies and relationships. Many companies have demonstrated to us and to policymakers that they are effectively incapable of establishing new manufacturing pipelines overnight.

“Immediate 100% tariffs on medications simply cannot accomplish our shared goal of fortifying domestic biomedical manufacturing. Further, doing so will disproportionately undermine small- and mid-sized life sciences companies whose existence and solvency depend upon time and stability to attract the significant capital needed to continue fueling the engine of biomedical innovation in the U.S.

“This comes at a time when international competitors are pulling out every stop to overtake the U.S. in dominating both innovation and manufacturing in the life sciences. BioNJ is proud that New Jersey is one of a handful of crucial nodes of American biomedical innovation, and we ardently agree that the U.S. should do all that we can to maintain our status as the global center of this innovation. To do so will require a nuanced and intentional plan, and BioNJ welcomes the opportunity to support this mission while ensuring that innovation can flourish to ensure the U.S. is as competitive and secure as possible for years to come. Overnight 100% tariffs are not the pathway to success, but we — along with our Member companies — stand ready to chart out that pathway with policymakers at all levels of government.”

A statement by BioNJ President & CEO Debbie Hart:
“A proposed new patent fee under consideration by the U.S. Commerce Department threatens to undermine America’s innovation ecosystem. The plan would impose an annual fee of up to 5% of a patent’s assessed value ― effectively taxing innovations as if they were tangible property. This fee structure would punish invention rather than promote it, discouraging risk-taking and driving talent and investment overseas. Innovation often begins with individuals or small entities with limited resources; raising barriers to protecting their ideas reduces the chances that those breakthroughs will ever reach the Patients who need them.

“America’s global leadership in innovation has long depended on a strong, accessible patent system that rewards breakthrough thinking ― not one that penalizes it. BioNJ urges policymakers to reject this harmful proposal and protect the integrity of a system that has fueled U.S. economic and scientific leadership, with New Jersey at the helm, for more than two centuries.”

“The Centers for Disease Control and Prevention (CDC), along with the scientists and public health specialists whose work and guidance have always been grounded in the best available evidence, represent the global standard for how nations can navigate emerging and ambiguous threats to public health and national security. Together with the National Institutes of Health (NIH), these institutions form critical components of the nation’s public life sciences infrastructure. They are essential threads in the tapestry that has made the United States the global leader in both innovation and resiliency.

“BioNJ is pleased to see that the House Appropriations Committee has recognized the value the NIH brings in supporting early-stage innovation ― an area central to U.S. international competitiveness. However, we are hopeful that the CDC’s equally vital role is also acknowledged. The CDC is key in strategically deploying the strength, capabilities and resources of the entire U.S. life sciences ecosystem to respond to unpredictable public health threats as rapidly and effectively as possible. We urge that the proposed cuts to CDC funding be reconsidered.”

“BioNJ is concerned by the abrupt dismissal of the members of the Advisory Committee on Immunization Practices (ACIP) ― a body that is critical to ensuring that vaccines are thoroughly vetted to be safe and effective. ACIP is the global gold standard and a source of significant scientific pride for the United States. Any action that weakens its ability to evaluate emerging vaccines would jeopardize global health and our nation’s leadership in developing the most effective vaccines in the world. It is imperative that every individual selected for this critical role demonstrates a proven track record in immunology and vaccine development. Any delay in ACIP’s vital work will directly hinder Patients’ access to the newest, most effective vaccines ― costing lives that could otherwise be saved.” 

“BioNJ is deeply concerned about the Most Favored Nation Executive Order issued by President Trump today. This concept, which intends to link prescription drug prices that are paid in the United States, to those in other nations, is a deeply flawed attempt to enable the government to control prices which economic assessments have shown will not only decimate innovation in the life sciences — but will also essentially mimic policymaking in nations that generate a fraction of the diversity of treatments and cures that American companies have been able to bring to Patients.

New Jersey is home to one of the most productive centers of biomedical innovation in the world. We are tremendously proud that our State produces so many new and effective medications for Patients globally. I’m very hopeful that policymakers in D.C. will appreciate that the implementation of a policy concept like this would not only inhibit our state’s ability to innovate — it will mean that Patients will have access to fewer new treatments and cures.

As we have over the past few weeks, BioNJ will continue to connect with members of multiple state congressional delegations to convey why this is misguided policymaking and how it will fail to redound to the benefit of anyone other than our nation’s economic competitors who are aggressively pursuing policies to foster innovation in their own life sciences sector rather than inhibit it.”

“Following the Governor’s Budget Address, BioNJ looks forward to continuing to work with the Governor’s office and the Legislature to accomplish our shared goals of attracting even more world class life sciences companies to New Jersey. We support ensuring that New Jersey remains a ‘bedrock of innovation’, and we look forward to seeing the full budget soon. To ensure that New Jersey remains nationally competitive, offering the types of credits and incentives outlined by the Governor can effectively attract companies from across the globe. It is prudent policy to both support the State’s economy — and also, importantly, ensure the life sciences sector continues to create new and more effective medications, Because Patients Can’t Wait®.” 

“BioNJ is concerned by the announced cut of indirect cost rates at the National institutes of Health (NIH). The life sciences ecosystem in the United States is the world’s dominant source of biomedical innovation. A critical component of that international competitiveness is the relationship between academic biomedical research and the ability of the life sciences sector to translate those innovations at their earliest stages to medicines and treatments that improve the lives of Patients. This relationship is key, and the federal government’s support for the innovation that takes place at universities is at the heart of why the United States leads the world in the research that quite literally saves and improves lives. Beyond that, investment in America’s universities, and investment in the NIH, has been repeatedly shown to produce a significant return on investment — ultimately reducing rather than increasing costs.

These cuts will inevitably result in a diminished workforce among New Jersey’s universities and nationwide. These are the jobs that fundamentally enable the R&D at universities that are major contributors to the ability of the life sciences sector to support the global competitiveness of the United States — and equally importantly — result in the treatments and cures that are the main source of hope for Patients worldwide. Ideally, the Trump administration will reconsider seeing these funding reductions as a potential cost saver and will rather appreciate that it is an investment in the nation’s national competitiveness and ultimately a cost saver.”

“BioNJ is pleased to see that Congress continues to scrutinize the business practices of pharmacy benefit managers (PBMs), following the release of the Federal Trade Commission’s (FTC) second interim staff report. As expected, the FTC found that the three largest PBMs have engaged in practices that dramatically inflate the prices of medications — in some cases by over 1000% for specialty generic drugs dispensed at their affiliated pharmacies. Further, the FTC found that the ‘majority of the most highly marked up specialty generic drugs were dispensed by PBM-affiliated pharmacies’.

As the government continues to uncover the impact that PBM business practices have had on the prices that Patients confront, we hope to see legislatures at both the state and federal level seize opportunities to address the core drivers of unaffordability. These practices are what separate Patients from the medications they need, and so we look forward to working with policymakers to ensure that every opportunity to increase access and innovation is pursued.”

“BioNJ was pleased to see that, in his State of the State Address, Governor Murphy emphasized the importance of innovation to the health and success of New Jersey’s economy. As we have over the course of the Governor’s administration, we look forward to working with the Governor and other policymakers as well as our Members to continue earning the reputation as the “Medicine Chest of the World” and supporting the Governor’s priority to ensure that our State is home to a growing number of innovators who are making their mark. As the Governor noted, “the best way to predict the future is to create it” — and as representatives of the industry responsible for more FDA approvals than any other State in the country, we will continue to support that vision, Because Patients Can’t Wait®.”

“Ahead of its December 20th deadline, Congress has released language for an end-of-year continuing resolution (CR) that will keep the government funded for three more months. BioNJ applauds the inclusion of several pivotal, Patient-centered programs, such as enhancing transparency in pharmacy benefit managers (PBMs) and extending the Pediatric Priority Review Voucher (PPRV) program through 2029, a vital incentive for developing treatments for rare pediatric diseases. The package also extends provisions in the Pandemic and All-Hazards Preparedness Act (PAHPA), and BioNJ was pleased to join our partner organizations across the country to urge the included PPRV reauthorization. This bipartisan spending package includes policies aimed at improving access to life-saving medicines, strengthening America’s biotechnology leadership and enhancing preparedness for future public health emergencies. We strongly urge our congressional representatives to support this critical legislation – Because Patients Can’t Wait®.”

“BioNJ applauds New Jersey Senator George Helmy for joining Senator Cory Booker in supporting the Health Equity Innovation Act of 2024 (S.4592). This bill would provide federal resources to institutions that have demonstrated an effective devotion to addressing health inequities and underserved communities. Any effort to ensure that Patients have access to the treatments that they need is paramount, and this bill would further that effort. We look forward to continuing to work with both Senators and other policymakers at the state and federal levels to achieve the fundamental goal of ensuring that every Patient has access to the most effective therapeutics as soon as possible.”

“BioNJ is heartened that the Supreme Court has decided to ensure access to mifepristone, as the alternative would have impeded a pregnant person’s right to choose. Importantly, it also would have jeopardized the FDA’s authority and decision-making, fundamentally undermining the scientific basis by which they determine safety and efficacy of medications. We realize that this conversation may not be over but we applaud the Supreme Court’s decision today.”

“While we certainly share President Biden’s goals to reduce barriers to Patient access and develop new and more effective medications to cure cancer, BioNJ is disappointed that, in his State of the Union Address, the President continued to pursue policies that will inevitably diminish the ability of the life sciences industry in the United States to continue leading the world in biomedical innovation. As the sole sector poised to ultimately “end cancer as we know it,” as acknowledged by the President, the ecosystem is already adjusting to the challenges posed by the pricing provisions in the Inflation Reduction Act. We are proud that New Jersey is home to one of the nation’s crucial clusters of biopharmaceutical companies, and we are proud that so many life-saving medications emerge from our State. There are bipartisan opportunities to address some of the unintended consequences of the Inflation Reduction Act — and, if the President truly wishes to accomplish many of the goals highlighted in his speech, we hope that he and his administration will work with the sector to pursue policies that will enable that success rather than impede it.”

“BioNJ is pleased that the World Trade Organization did not expand the TRIPS waiver beyond its initial application to vaccines developed to defend against COVID-19. Given the crucial role that strong intellectual property protections play in the ability for life sciences companies to develop new and more effective medicines, and innovation across the life sciences ecosystem, it is encouraging that this expansion was not adopted. We look forward to continued collaboration with policymakers at the State and federal levels to pursue policies that will effectively ensure that every Patient has access to the treatments they need when they need them.”

“BioNJ is thrilled that a bill to reauthorize the successful Pediatric Rare Disease Priority Voucher Program for an additional four years has recently been introduced in the U.S. Congress. This program has been demonstrated to stimulate drug development for rare pediatric diseases, and these conditions affect over 10 million children in the United States alone. Assessments of this program have demonstrated that the program has effectively accelerated access that pediatric Patients have to medications developed to treat these conditions, for which only approximately 5% have effective treatments, and so we are hopeful that policymakers in New Jersey and across the country consider supporting the Creating Hope Reauthorization Act of 2024.”

“For the sixth year in a row, at BioNJ, we were heartened to see Drug Channels’ report that, once again, brand-name drug net prices fell…this year by 7.4% inflation-adjusted and are expected to fall further still in 2024. The narrative that drug prices continue to rise is patently false, ignores the facts and should be disputed and explained at every turn. Patients and policymakers deserve to know the truth so that policies and practices can be modeled to reflect reality. Because Patients Can’t Wait®.”

Earlier this month, the Biden Administration announced a proposal to allow the use of “March-In” rights under the Bayh-Dole Act to license the patent rights of drugs to other biopharmaceutical manufacturers when the price of the drug is deemed to be too high. Debbie Hart, President & CEO of BioNJ, released the following statement in response to the proposal: “BioNJ is deeply concerned by and disappointed in the Biden Administration’s proposed framework on March-In rights, which is a departure from previous interpretations of the Bayh-Dole Act and would enact price controls that will stifle biopharmaceutical innovation, reduce competition and harm Patients’ health. Bayh-Dole has been central to the creation of new and more effective therapeutics and has helped preserve important components of the life sciences ecosystem in New Jersey and beyond for decades. We urge the Biden Administration not to proceed with adoption of this proposed framework. BioNJ calls on White House leaders to preserve the value that the Bayh-Dole Act has generated, protect U.S. leadership in medical innovation from the severe consequences that a decline of patent incentives would create, and avoid discouraging vital public-private partnerships that enable significant medical breakthroughs for Patients. BioNJ will continue to convey to federal policymakers the crucial benefits that strong patent protections have produced for Patients. Rather than advancing policies that threaten the patent system, the bedrock of American leadership in innovation, policymakers must support commonsense reforms that address the true drivers of high Patient costs, such as opaque Pharmacy Benefit Manager (PBM) practices and insurer tactics that disrupt treatment access. We remain steadfast in our mission of ensuring that the life sciences ecosystem in New Jersey and across the country can continue to bring new and more effective therapeutics to Patients worldwide and hope the Biden Administration will consider the ramifications of its proposal.”

“BioNJ applauds the White House Initiative on Women’s Health Research to address gaps in women’s health research and to drive innovation. There is an urgent need to improve how research into women’s health needs is conducted and to close the gaps to diagnose and treat various conditions prevalent in women, such as cardiovascular disease, Alzheimer’s disease, rheumatoid arthritis, mental health conditions, menopause and endometriosis. This initiative will establish clear priorities on how research into women’s health needs is conducted, enhance coordination among Federal agencies, engage scientific communities and promote public-private partnerships. BioNJ is excited about the promise of this new initiative to address the unique health needs of women by fostering a more inclusive approach to advance women’s health research and to achieve the next generation of innovation.”

“BioNJ urges the passage of H.R. 2673, the American Innovation and R&D Competitiveness Act and S. 866, the American Innovation and Jobs Act, which would permanently repeal the Research and Development (R&D) amortization provision. For nearly 70 years, the tax code recognized the importance of R&D by allowing businesses to fully deduct their R&D expenses in the same year they were incurred. Unfortunately, starting in 2022, the tax code has required businesses to amortize (or deduct over a period of years) their R&D expenses, making R&D more costly to conduct in the United States. This harmful tax change has resulted in significant cash flow impact on businesses, particularly for start-ups and small biotechs that drive innovation. H.R. 2673, the American Innovation and R&D Competitiveness Act and S. 866, the American Innovation and Jobs Act seek to undo the 2017 provisions that disincentivize R&D investment. BioNJ participated in a multi-state Congressional briefing in Washington D.C. on this important legislation, where BioNJ member company PC Therapeutics conveyed the support for this policy remedy shared by the full life sciences ecosystem in New Jersey. BioNJ strongly encourages our elected leaders in Congress to support the extension of longstanding tax incentives for R&D and the passage of this important legislation which is essential to ensure future innovation.”

“BioNJ congratulates Monica Bertagnolli, M.D. on her confirmation in the U.S Senate to become Director of the National Institutes of Health (NIH). Dr. Bertagnolli is a renowned oncologist, cancer researcher and educator and will provide strong leadership as the NIH works to improve the health and well-being of Patients. Dr. Bertagnolli previously served as Director of the National Cancer Institute, becoming the first woman to lead the institute, as well as the Richard E. Wilson Professor of Surgery in oncology at Harvard Medical School. BioNJ is excited to have Dr. Bertagnolli lead the NIH and to address the health threats of today and in the future and ensure that the essential relationship between academia and the life sciences sector continues to support the innovation on which Patients rely.”

“BioNJ has significant concerns with The Centers for Medicare & Medicaid Services (CMS) proposed rule “Misclassification of Drugs, Program Administration and Program Integrity Updates under the Medicaid Drug Rebate Program” (MDRP). The proposed changes to the MDRP would require manufacturers to aggregate or “stack” all discounts and rebates provided throughout the supply chain when determining the “Best Price” benchmark used as the basis for Medicaid rebates for numerous drugs. In addition to the operational complexities in this sweeping proposal and changing the calculation of “best price,” “stacking” would negatively impact Patient access to innovative new treatments. These changes jeopardize the successful Medicaid program that has been in existence for 30 years and would place a significant burden on programs such as 340B. BioNJ recently joined with our peer members of the Council of State Bioscience Associations (CSBA) in sending this petition to federal lawmakers urging CMS to withdraw this rule as these significant policy changes will risk increasing out-of-pocket costs for Patients and inhibit access to innovative therapies and cures.”

“BioNJ strongly advocates the passage of the Optimizing Research Progress Hope and New Cures Act (ORPHAN Cures Act) to ensure new rare disease drug development in the face of harmful provisions in the Inflation Reduction Act (IRA). The ORPHAN Cures Act would change the incentive structure within the IRA to encourage follow-on investment into orphan drug development. Currently, the IRA only exempts orphan drugs for rare diseases from the price negotiations if the drugs are approved for a single indication. As a result, drug manufacturers are disincentivized to test whether a new drug can treat other indications. By discouraging research into second indications, the IRA hinders the discovery of orphan drugs. BioNJ urges our leaders in Congress to amend the IRA and pass the ORPHAN Cures Act so that scientists can continue to discover cures for the thousands of Patients suffering from rare diseases…Because Patients Can’t Wait®.”

“The United States International Trade Commission (ITC) has released its report on the potential expansion of the TRIPS waiver for COVID-19 vaccines to include diagnostics and therapeutics. As Debbie Hart, President & CEO of BioNJ, testified before the ITC earlier this year, this expansion would not only fail to increase Patient access it would also have a disproportionate impact on the life sciences ecosystem in New Jersey, one of the State’s foundational economic sectors. BioNJ hopes that the U.S. Trade Representative considers all the data that informed the ITC’s report and comes to a determination that facilitates continued biomedical innovation in the United States and beyond and ensures that Patients can access the treatment they need when they need it. We look forward to the final decision.”

“BioNJ is concerned by the ramifications of the shutdown of the federal government, both due to the resulting inhibition of innovation in the life sciences ― and, more importantly, for the delay in access to new treatments and cures on which Patients are relying. While a majority of the FDA reviews of new medications are funded by the fees that life sciences companies pay, and are insulated from the shutdown as a result, the FDA will be incapable of receiving fees for new applications for the duration of the shutdown. As a result, there will be an inevitable delay in the availability of new therapeutics to Patients. We hope that policymakers will come to a compromise soon because Patients Can’t Wait.”

“BioNJ applauds the Food and Drug Administration (FDA) announcement approving updated COVID-19 shots for everyone 6 months and older to give Americans added protection ahead of a potential winter increase in infections. BioNJ also commends the biopharmaceutical companies and their researchers who in response to an unprecedented public health crisis developed multiple vaccines that were critical to saving lives and getting the country back to normal. COVID-19 treatments and vaccines have saved millions of lives and billions of dollars. In fact, between December 2020 and March 2022. U.S. vaccination efforts prevented: 2.3 million deaths and 66 million infections. As we continue to fight COVID-19, while also developing new cures in all disease states, it is important to preserve the robust U.S. biopharmaceutical research ecosystem by ensuring we have policies that support Patient access and affordability without undermining the development of tomorrow’s life-saving medicines.”

“BioNJ congratulates Secretary Tahesha Way on her appointment as Lieutenant Governor. We look forward to continuing to work with Governor Murphy and his administration, including the Lieutenant Governor, to foster growth across the State’s life sciences ecosystem to ensure that New Jersey remains one of the nation’s primary hubs of biomedical innovation.”

“BioNJ has serious and significant concerns regarding the Centers for Medicare and Medicaid Services (CMS) announcement today outlining the 10 Medicare Part D Drugs subject to “price negotiation” under the Inflation Reduction Act (IRA). The government’s arbitrary, opaque and unpredictable process for deciding the price of medicines will drive research and investment away from potentially lifesaving treatment options for Medicare Patients. The companies targeted by this policy account for a substantial proportion of all investment in R&D across the life sciences which will be severely diminished and undermined as a result. Even worse, seniors may not actually benefit from this government price setting and could, in fact, see their access restricted. The IRA ignores the existing savings from private sector negotiation and competition in Part D and fails to require insurers and PBMs to share these savings with seniors which would more directly lower out-of-pocket costs than government-mandated price setting. We hope that policymakers will consider more effective opportunities to implement policies that would truly lower the costs that Patients face.”

“BioNJ expresses its heartfelt condolences on the passing of the Honorable Sheila Y. Oliver, Lieutenant Governor of New Jersey. Lt. Governor Oliver was a true trailblazer and tireless advocate for the people of New Jersey. We are all indebted to her dedication and service and know her life will serve as an inspiration for all of those whose lives she has touched and for generations to follow. Our thoughts and prayers are with Lt. Governor Oliver’s family, friends, colleagues and all who knew and loved her.”

“We would like to congratulate Health Commissioner Judith Persichilli on her upcoming retirement. In 2022, BioNJ had the honor of presenting Commissioner Persichilli with the Dr. Sol J. Barer Award for Vision, Innovation and Leadership for her tireless work on behalf of Patients and her unwavering dedication as she led the State’s response to the COVID-19 pandemic. A longtime nurse and hospital executive, Ms. Persichilli proved time and time again her unwavering commitment to the residents of New Jersey by diligently working to protect our communities and improve New Jersey’s health care system. We would like to thank the Health Commissioner for all that she has done for the State and wish her a wonderful and joyful retirement.”

“BioNJ is disappointed in the recent decision by the Centers for Medicare & Medicaid Services (CMS) that Medicare will cover drugs that slow Alzheimer’s disease only once they receive “traditional full approval” by the U.S. Food and Drug Administration (FDA) and require physicians to participate in registries that collect evidence about how these drugs work in the real world after already receiving accelerated approval. Mandating that doctors participate in a health agency database and Patients to participate in registries that collect data will pose unnecessary barriers to the access of these important medicines. CMS also needs to recognize that medicines approved through the Accelerated Pathway, which began more than three decades ago, with 260 medicines having been granted accelerated approval today, are safe and effective. With more than 6.7 million individuals in the U.S. suffering from Alzheimer’s disease, BioNJ is concerned the decision by CMS severely limits coverage for an entire class of new Alzheimer’s therapies with FDA approval.”

“BioNJ is disappointed in the decision of the U.S. Court of Appeals for the 5th Circuit to uphold a federal court ruling that ordered the U.S. Food and Drug Administration (FDA) to withdraw its authorization of mifepristone used in medication abortion, a drug approved more than two decades ago. This decision undermines the FDA’s drug approval authority, establishes a dangerous precedent to potentially contest approvals or regulatory decisions related to other medications and ultimately will have an impact on future drug research and development by biopharmaceutical companies. The FDA is the gold standard for drug approval. We need to defend and uphold FDA’s role and mission of ensuring the safety and efficacy of medicines and preserve a policy environment that supports the agency’s ability to regulate and provide access to FDA-approved medicines. BioNJ urges the U.S. Supreme Court to overturn the Texas Court decision so that the biopharmaceutical industry can continue to develop medical breakthroughs that will improve and extend the lives of Patients in the U.S. and around the world.”

“BioNJ strongly supports the passage of the reintroduced PASTEUR (Pioneering Antimicrobial Subscriptions to End Upsurging Resistance) Act which would commit $6 billion to reinvigorate innovation in much needed Research and Development of new antimicrobials and antibiotics. Superbugs were linked to nearly 5 million deaths worldwide in 2019, making antimicrobial resistance (AMR) a leading cause of mortality worldwide. The Centers for Disease Control and Prevention (CDC) estimates that at least 2.8 million people across America suffer from antibiotic resistance annually, and at least 35,000 people die as a result. The PASTEUR Act is an integral solution to addressing the global public health crisis of AMR and will drive the development of new, innovative treatments for Patients. It is critical that this bipartisan legislation be passed to ensure the expansion of the pipeline for next generation antibiotics to combat the threats we face today and will face in the future.”

“BioNJ commends the decision of the U.S. Supreme Court to defend and uphold the U.S. Food and Drug Administration’s (FDA) role and mission of protecting the public health by ensuring the safety and efficacy of medicines. The recent Texas Court decision to suspend the FDA’s approval of abortion pill mifepristone would have undermined the FDA’s drug approval authority, establish a dangerous precedent to potentially contest approvals or regulatory decisions related to other medications and ultimately have an impact on future drug research and development by biopharmaceutical companies. The FDA is the gold standard for drug approval since Congress gave the FDA overarching authority to determine whether drugs are safe and effective in the Food, Drug and Cosmetic Act of 1938. BioNJ is encouraged by this decision that will help to ensure a policy environment that supports the agency’s ability to regulate and provide access to FDA-approved medicines. This ruling will enable the biopharmaceutical industry to continue to develop medical breakthroughs that will improve and extend the lives of Patients in the U.S. and around the world.”

“BioNJ is very concerned about the Medicare Payment Advisory Commission (MedPAC) proposal being considered this week to adjust the payment for Part B medicines with accelerated approval. This MedPAC proposal could compromise Patient access to serious and life-threatening diseases and have a disproportionate impact on smaller and rural communities, where independent practices struggle to cover the cost of medicines. Accelerated approval has helped speed the availability of over 250 new medicines for Patients, often for serious or life-threatening diseases while adhering to the same safety and effectiveness standards as traditionally approved medicines. If biopharmaceutical companies know that reimbursement for a medicine is going to be artificially cut simply based on the use of accelerated approval, they are less likely to seek it. Knowing that Part B medicines make up less than 5% of total government Medicare spending, that prices for Part B medicines have grown more slowly than medical inflation, and the vast majority of the required confirmatory trials for drugs approved under Accelerated Approval are on schedule, BioNJ encourages MedPAC not to approve this proposal and to protect Patients’ access to medicines in Part B.”

“BioNJ is concerned that the recent Texas Court decision to suspend the U.S. Food and Drug Administration’s (FDA) approval of abortion pill mifepristone could undermine the FDA’s drug approval authority, establish a dangerous precedent to potentially contest approvals or regulatory decisions related to other medications and ultimately have an impact on future drug research and development by biopharmaceutical companies. The FDA is the gold standard for drug approval since Congress gave the FDA overarching authority to determine whether drugs are safe and effective in the Food, Drug and Cosmetic Act of 1938. It is critical to ensure a policy environment that supports the agency’s ability to regulate and provide access to FDA-approved medicines. Furthermore, the expensive and risky research and development undertaken by the biopharmaceutical industry could be compromised with a greater focus on medicines perceived to be safer investments. Bottom line: It is of paramount importance that the FDA remains the authority of determining drug safety.”

“Giving away American intellectual property on treatments to foreign countries will undercut American medical innovation, outsource U.S. manufacturing jobs, and weaken U.S. leadership in the biopharmaceutical sector. The potential negative impact of the extension of the TRIPS waiver is real.”

“BioNJ is deeply concerned that President Biden’s 2024 budget proposal which would expand price negotiations for more drugs as well as move up the start date of negotiations to shortly after the launch of new medicines – will stifle life sciences innovation and undermine access to life-saving medicines for Patients. The Inflation Reduction Act already forces life sciences companies to make difficult choices, including shifting focus away from certain types of medicines and discouraging the research that takes place after medicines are first approved. BioNJ stands ready to work with our legislators to advance policies that can help lower costs for Patients, protect medical innovation and ensure access to the cures and treatments Patients need.”

“BioNJ is disappointed in the recent decision by the Centers for Medicare and Medicaid Services (CMS) to limit coverage of Alzheimer’s drugs. CMS declined to reconsider the national coverage determination (NCD) that Medicare would cover monoclonal antibodies targeting amyloid plaque for the treatment of Alzheimer’s ‘only if they have received traditional approval from the U.S. Food and Drug Administration (FDA): drugs receiving Accelerated Approval would only be covered for Patients in clinical trials. The CMS decision severely restricts Patient access to FDA Accelerated Approvals for breakthrough Alzheimer’s drugs ― Aduhelm and LEQEMBI the first in 20 years. These restrictions represent a significant setback for the over 3 million Americans who are experiencing mild symptoms of Alzheimer’s, an unprecedented infringement on FDA’s scientific autonomy and decision making and will significantly influence future innovation and investments in these novel therapies.”