The Institute for Patient Access recently wrote a blog post that recapped some of the presentations at the 2017 Infant Health Policy Summit. The blog post highlights the speech given by Newborn Health Initiative Director Andy Rosenberg, who stressed the need for new incentives to develop life-saving neonate drug therapies. "Incentives have led to an increase in pediatrics studies submitted to the FDA, Rosenberg explained, but few labeling changes have included neonates – babies 28 days old or younger. The Promoting Life-Saving New Therapies for Neonates Act, HR 2641, gives Rosenberg hope that this trend can finally be reversed.
Newborn Health Initiative's Andy Rosenberg Stresses Need for New Therapy Innovations at the 2017 Infant Health Policy Summit
Today, Newborn Health Initiative Director Andy Rosenberg delivered a presentation at the National Coalition for Infant Health's 2017 Infant Health Policy Summit. His powerful story in his opening remarks underscored the urgent need to promote innovation in drug therapies for our healthcare system's most vulnerable constituency - our newborn babies. "When I first became involved with the Initiative, I fully expected to learn a lot, and was prepared to be moved by the experience of working on such an emotional issue," said Rosenberg. "What I didn’t really expect, however, and what I somehow failed to see, was that I would find myself becoming personally invested because I myself was, a neonate patient."
Newborn Health Initiative champion Jennifer Degl recently penned an article in the International Neonatal Consortium (INC) newsletter, sharing her story and experience as the mother of a premature baby. In the piece, Degl emphasizes the importance of INC’s role in increasing the number of neonatal drug therapies available in order for this extremely vulnerable population to grow up and live happy, healthy lives. “With proper timing and communication strategies in place, I believe that the INC can work to increase the neonatal drug options and availability of those drugs, so that we can improve the lives of our future neonatal population,” wrote Degl. “I am excited to be a part of such important work.”
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.
Last night, Comedian and Television Host Jimmy Kimmel gave a heartfelt, emotional opening monologue detailing his newborn son Billy's emergency surgery to correct defects in his heart. A few hours after his birth, a nurse noticed a murmur in Billy's heart. Kimmel noted that the hospital team started doing some tests to see whether it might just be fluid in the lungs. Doctors then pivoted to his heart, and performed an echocardiogram that found Billy was born with a heart defect called tetralogy of Fallot with pulmonary atresia. Kimmel recounted the events leading up to and after the surgery.
Newborn Health Initiative Champion Jennifer Degl's Blog on experience at the 3rd Annual FDA-INC Neonatal Scientific Workshop
A recent study reported in the Associated Press has found that a surge in U.S infants born with symptoms of withdrawal from heroin or strong prescription painkillers is driven largely by rising drug use among women in rural areas. "Newborns whose mothers use these drugs during pregnancy are at risk for seizures, excessive crying, problems with breathing, sleeping and feeding and other withdrawal symptoms," the article notes. "Treatment sometimes includes methadone and babies may need to be hospitalized for weeks or months."
A recent article in the British Journal of Clinical Pharmacology (BJCP) highlights the history behind why there is currently a severe shortage of medical innovation for newborns. "The need for paediatric studies persists and new efforts to increase the study of drugs in neonates and to improve the efficiency of these studies are underway," the study says. "We can look to a future when neonatal drug therapy has the same solid data base that is provided for treatment of older children and adults."
Incoming Chair of AAP, SOATT Section Focuses on Advancing Therapeutics and Technology for Neonates in First Newsletter Post
In the Fall 2016 American Academy of Pediatrics (AAP) Newsletter, incoming Chair of the Section on Advances in Therapeutics and Technology (SOATT) Dr. Mitchell Reid Goldsten focuses on the need to improve medical innovation for neonates. "There is no excuse for lack of acceptable pediatric devices or medications due to inadequate resources for research and development," he writes. "The Promoting Life Saving New Therapies for Neonates Act of 2015 (S. 2041 and H.R. 5182) is an example of legislation designed to bridge the gap... This legislation would mark a promising step forward in creating appropriate incentives to bring new treatments forward to benefit this vulnerable population."