A Memoir of a Mother’s Determination and Her Micro Preemie’s Struggle to Beat the Odds
Please join me on Wednesday, March 23 at 8:00 pm (EST) for an important, parent-led FREE webinar to examine new congressional legislation aimed at incentivizing research into therapies for neonates.
We are discussing Senate Bill S.2014 (Promoting New Life Saving Therapies for Neonates Bill) and we can all help get it passed. I am a member of the speaker’s panel and I hope that you will tune in to learn more of what the bill is about.
Your participation and engagement in this activity is essential to focusing Washington’s attention on the decades-long crisis concerning the lack of innovation in preemie health.
This special policy event will feature experts with unique backgrounds and experiences in preemie health- who will discuss the issues related to pharmaceutical innovation in this unique space and help educate parents and other stakeholders on what we can do to help.
Click HERE to register.
The Newborn Health Initiative represents a coordinated effort of healthcare stakeholders – individuals and organizations – to support legislation that has been introduced in the United States Senate to address the dire gap in our innovation pipeline for neonatal therapies.
We are parents and loved ones, nurses and doctors, researchers and innovative pharmaceutical companies. We are people who recognize, either due to personal experience or professional background, that our healthcare system is failing its most vulnerable constituency – our newborn babies.
Annually, approximately 200,000 newborns in the United States require admission to a neonatal intensive care unit for treatment of prematurity, costing more than 26 billion dollars per year. Prematurity is the leading cause of newborn mortality and the second leading cause of infant mortality. 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.
Federal legislation implementing a combination of pediatric incentives and obligations has led to an increase in pediatric studies submitted to the FDA, resulting in over 500 product labeling changes since the enactment of the Food and Drug Administration Modernization Act (FDAMA) in 1997. Despite these policy efforts, few drug-labeling changes have included neonates (premature and full term infants up to 28 days of age); and the last new drug for neonates was approved in 1999.
Current incentives have not been sufficient to stimulate innovation for the neonatal population due to numerous challenges. For example, very few patients are available for study at any given time so it is difficult and costly to get sufficient numbers. The patients are also very sick so it is difficult to get informed consent from caregivers. Furthermore, many conditions for which drug therapy is needed in the neonatal population do not occur in older children and adults.
Fortunately, legislation has been recently introduced to stimulate drug development specifically for the neonatal population. Specifically, the legislation will:
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.
So, please join me and other members of the “preemie expert panel” to discuss Senate Bill S.2041 on Wednesday night at 8 pm (EST) to learn more about the bill and what you can do to help.
Again, click HERE to register.
Most of this information was originally posted on www.newbornhealth.org