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Who We AreThe Newborn Health Initiative represents a coordinated effort of healthcare stakeholders – individuals and organizations – to support legislation that has been introduced in the United States Senate to address the dire gap in our innovation pipeline for neonatal therapies.
We are parents and loved ones, nurses and doctors, researchers and innovative pharmaceutical companies. We are people who recognize, either due to personal experience or professional background, that our healthcare system is failing its most vulnerable constituency – our newborn babies. |
The ProblemAnnually, approximately 200,000 newborns in the United States require admission to a neonatal intensive care unit for treatment of prematurity. Prematurity is the leading cause of newborn mortality and the second leading cause of infant mortality. Among those who survive, one in five faces health problems that persist for life such as cerebral palsy, intellectual disabilities, chronic lung disease, and deafness. But unfortunately, current incentives have not been sufficient to stimulate novel therapies for the neonatal population due to numerous challenges.
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The SolutionFortunately, legislation has been recently introduced to stimulate drug development for the neonatal population. Specifically, the legislation will: (1) close the treatment gap by stimulating the development of safe and effective drugs for a challenging and neglected pediatric population; (2) ensure that new neonatal drugs address the most critical needs in the neonatal population by collaborating with multiple stakeholders to identify priority conditions; and (3) create a new incentive model by providing a transferrable "exclusivity voucher" to drug sponsors who successfully develop products for neonates, which would enable the product sponsor to extend the exclusivity period on another drug by one year.
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