Long introduces legislation to boost treatment for at-risk newborns

Statement

Congressmen Billy Long (MO-07) and Ben Ray Luján (NM-03) have introduced the "Promoting Life-Saving New Therapies for Neonates Act of 2016" to increase the availability of life-saving treatments for at-risk newborns. The bill will heighten innovation in neonatal drug therapies, improve outcomes for infants with devastating ailments, and give hope for a healthy life to those newborns that are most vulnerable.

"Families with children who are born prematurely or sick simply do not have enough options to save their newborns," said Rep. Long."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 well-being of these children should be our top priority. 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."

Congressman Luján: "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. 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."

The Promoting Life-Saving New Therapies for Neonates Act

For these reasons, we have introduced the Promoting Life-Saving New Therapies for Neonates Act of 2016 to stimulate drug development specifically for the neonatal population. 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.

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