Legislation introduced on Wednesday by U.S. Rep. Billy Long (R-MO) would make life-saving treatments for at-risk newborns more widely available.
The Promoting Life-Saving New Therapies for Neonates Act, H.R.5182, introduced by Long and U.S. Rep. Ben Ray Luján (D-NM), would promote innovative neonatal drug therapies that improve outcomes for at-risk infants.
“Families with children who are born prematurely or sick simply do not have enough options to save their newborns,” Long said. “Only one drug has been approved to help treat these infant patients in the past 16 years, while about 200,000 children are still being born each year that need intensive neonatal care in the US.”
The bill would close the treatment gap by encouraging the development of safe, effective drugs for infants, and would ensure that new neonatal drugs address the most pressing needs of at-risk babies by fostering collaboration among stakeholders like the National Institutes of Health, the Critical Path Institute and patient advocacy groups.
“The well-being of these children should be our top priority,” Long said. “This crucial bill would undo federal barriers to treatment innovation, so that researchers and medical experts across the country can find new ways to stay ahead of this threat and reduce preventable infant mortality.”
Under the legislation, a new incentive model would be created by providing a transferrable “exclusivity voucher” to drug sponsors that develop therapies for neonates. The voucher would allow a product sponsor to extend a drug’s exclusivity period by one year.
“When it comes to the development of new treatments that have the potential and promise to save lives, our most vulnerable children are too often left behind,” Luján said. “The fact is a variety of factors and challenges have hindered the development of much-needed therapies and stood in the way of progress treating newborns. This legislation will provide incentives to stimulate innovation and encourage research and development in this area of great need. In recent years, we have seen tremendous medical advancements, and with this bill, we can see that that our youngest children can benefit from the next breakthrough.”