There is a glaring innovation desert in neonatal health, and it’s due to a variety of factors. Unlike treatments used in other fields of medicine, most medications administered to preterm infants have not been fully studied to support their safety and efficacy. Over 90 percent have not been approved by the Food and Drug Administration for the prescribed indication. Performing clinical trials for a group of patients whose physiology is constantly changing — and whose physical health is already incredibly fragile — is extraordinarily difficult and also expensive. And despite previous legislative efforts directed at alleviating this problem, there has not been an FDA-approved new medication released for newborns since 1999.
That’s why this bill has historic importance. It provides incentives to our industry partners to take on the vital research and clinical trials that would otherwise be too complex and costly to perform. It helps identify and address the most critical needs in the neonatal population by fostering collaboration among multiple stakeholders, including the National Institutes of Health, the Critical Path Institute, patient advocacy groups, families, neonatal health professionals and more. And it encourages our health system to realize its potential in neonatal health by using every resource available to target the pressing issues facing babies.
At NANN, we are on the frontlines of providing the life-saving care needed by countless families across the country. But we recognize that we are not in this fight alone. With its power to grant the FDA the authority to issue new incentives for neonatal-specific drug development, we look to Congress to serve as powerful allies and advocates for their newborn constituents. It is only through a coordinated, comprehensive approach that we can ease the pressures placed on our healthcare systems and professionals, who are confronting the difficult challenges of neonatal disease with a limited arsenal of treatments. As someone who has witnessed newborns struggle simply to survive, I am convinced that there is more to be done.
Every loving parent, every caring nurse, and every beloved newborn is a reminder that we can – and we must – do more for the critically ill babies who cannot speak up for themselves or cast votes in their name. NANN applauds Sen. Casey and Sen. Cassidy for their vision and leadership in calling attention to an issue that has been too frequently overlooked, and for supporting a population that has for too long been underserved. We hope that their colleagues in the Senate will add their names to this vital piece of legislation and that it will be enacted into law during this session of Congress. And we urge the rest of the nation to join in on this important movement to ensure that we, as a healthcare community, bring groundbreaking cures for newborns into the 21st Century.
Wakako Eklund is a Neonatal Nurse Practitioner with the Pediatrix Medical Group of Tennessee in Nashville and the National Association of Neonatal Nurses representative to the International Neonatal Consortium.