“The safety of American children is paramount. We should encourage the research and medical professional communities countrywide to excel, imagine, and innovate to keep that protection in the forefront,” said Sen. Casey. “Providing the resources needed to ensure that the hundreds of thousands of premature newborns are cared for and that as a community we are making strides to significantly lower the cases of preventable infant mortality is key.”
Annually, approximately 200,000 newborns in the U.S. require admission to a neonatal intensive care unit for treatment of prematurity, costing more than $26 billion per year. 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.
Despite this, the last new drug approved by the FDA for neonates was in 1999. The Promoting Life Saving New Therapies for Neonates Act looks to stimulate innovation for the neonatal population by increasing incentives and reducing some of the challenges the medical community faces.
The legislation will:
- Close the treatment gap by stimulating the development of safe and effective drugs for a challenging and neglected pediatric population.
- Ensure that new neonatal drugs address the most critical needs in the neonatal population by collaborating with multiple stakeholders, such as the NIH, the Critical Path Institute, and patient advocacy groups, to identify priority conditions.
- Create a new incentive model by providing a transferrable “exclusivity voucher” to drug sponsors who successfully develop products for neonates. This voucher would enable the product sponsor to extend the exclusivity period on another drug by one year.