Last week, 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.
The Newborn Health Initiative applauds Rep. Long’s efforts on behalf of the neonatal population, and urges Congress to pass this crucial bill. 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.
As one of the first lines of engagement in 2017, The Newborn Health Initiative encourages stakeholders to Tweet messages of gratitude to @USRepLong and @RepBenRayLujan. Additionally, we have set up a portal including a draft e-mail which stakeholders can utilize to Members of Congress to join as a co-sponsor of the legislation.
(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.
The Newborn Health Initiative applauds Rep. Long’s efforts on behalf of the neonatal population, and urges Congress to pass this crucial bill. 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.
As one of the first lines of engagement in 2017, The Newborn Health Initiative encourages stakeholders to Tweet messages of gratitude to @USRepLong and @RepBenRayLujan. Additionally, we have set up a portal including a draft e-mail which stakeholders can utilize to Members of Congress to join as a co-sponsor of the legislation.
