BioNJ Statements

“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.”