Reps. Billy Long (R-MO) and Ben Ray Juján (D-NM) re-introduced legislation -- The Promoting Life Saving New Therapies for Neonates Act (H.R. 2641) -- to boost the amount of life-saving treatments available for at-risk newborn babies. Approximately 200,000 newborns in the United States require admission to a neonatal intensive care unit every year. 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.
Specifically, this legislation will:
(1) Close the Treatment Gap: The bill would stimulate and incentivize the development of safe and effective drugs for the most vulnerable, neglected pediatric population.
(2) Promote Stakeholder Collaboration: The bill would ensure that new neonatal therapies address the most critical needs of the neonatal population through collaboration of multiple stakeholders including the National Institutes of Health, the Critical Path Institute, and patient advocacy groups.
(3) Create a New Incentive Model: The bill calls for the establishment of a “exclusivity voucher” to drug sponsors who successfully develop therapies for neonates. The vouched would enable the sponsor to extend the exclusivity period on another drug by one year Overall, this legislation will spur innovation for new neonatal drug therapies, improving outcomes for devastating neonatal conditions and giving our most vulnerable children the chance to become healthy, productive citizens.
This legislation represents an important step for improving outcomes for devastating neonatal conditions. By incentivizing innovation for new neonatal drug therapies, our most vulnerable children will have the chance to become healthy, productive citizens.
(1) Close the Treatment Gap: The bill would stimulate and incentivize the development of safe and effective drugs for the most vulnerable, neglected pediatric population.
(2) Promote Stakeholder Collaboration: The bill would ensure that new neonatal therapies address the most critical needs of the neonatal population through collaboration of multiple stakeholders including the National Institutes of Health, the Critical Path Institute, and patient advocacy groups.
(3) Create a New Incentive Model: The bill calls for the establishment of a “exclusivity voucher” to drug sponsors who successfully develop therapies for neonates. The vouched would enable the sponsor to extend the exclusivity period on another drug by one year Overall, this legislation will spur innovation for new neonatal drug therapies, improving outcomes for devastating neonatal conditions and giving our most vulnerable children the chance to become healthy, productive citizens.
This legislation represents an important step for improving outcomes for devastating neonatal conditions. By incentivizing innovation for new neonatal drug therapies, our most vulnerable children will have the chance to become healthy, productive citizens.
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