In-Depth: Rep. Lucille Roybal-Allard (D-CA) introduced this bill to eliminate preventable newborn deaths and severe disabilities through the increased use of comprehensive and standardized newborn screening tests by reauthorizing federal activities that assist states in improving and expanding newborn screening programs, supporting parent and provider newborn screening education and ensuring laboratory quality and surveillance:
“Newborn screening is one of the great public health success stories of our age. Our bipartisan Newborn Screening Saves Lives Reauthorization Act continues the oversight, coordination, and advancements made possible by both the original Newborn Screening bill and the Newborn Screening Saves Lives Reauthorization Act. I am very grateful for the longtime support of my colleague, Congressman Mike Simpson, who was critical in our efforts to pass both the original bill and the 2014 reauthorization, and I am happy to be joined in this reauthorization effort by Congresswomen Katherine Clark and Jaime Herrera Beutler. We all share a strong belief that where a baby is born should not determine its chance at a healthy future. The Newborn Screening Saves Lives Reauthorization Act will help ensure all newborn babies receive the comprehensive and consistent testing they need to have healthy, happy, and productive lives.”
Original cosponsor, Rep. Jaime Herrera Beutler (R-WA) added:
“When we make the effort early on to help children live full, healthy lives, that effort makes a profound difference throughout our communities. Every year, thousands of babies are born with health conditions that require early detection so doctors and parents can intervene with proper treatment. Through early intervention and treatment, children can be spared from serious, long-term health issues. I’m proud to join this bipartisan effort to ensure that comprehensive newborn screening programs continue and are improved to protect more babies.”
Original cosponsor Rep. Mike Simpson (R-ID) adds:
“I believe early detection and preventative medicine are some of the best ways to saves lives and reduce the cost of care. There is perhaps no greater example of this than newborn screening and this bill delivers the tools that allow nearly 12,000 babies each year to identify conditions that are rare but treatable. I applaud my friend and colleague Congresswoman Roybal-Allard for her work on this issue and I look forward to working with her again to advance this important legislation.”
The American Association for Clinical Chemistry (AACC) is among a number of organizations that supports this bill. In a press release, the organization writes:
“Almost all infants born in the U.S. undergo newborn screening, which is the practice of testing newborns for medical conditions that can cause disabilities, illness, or even death if not diagnosed and treated early. The Newborn Screening Saves Lives Reauthorization Act of 2019 will renew essential federal newborn screening programs for the next five years. The legislation will also help these programs to address new conditions and leverage emerging technologies, in addition to commissioning a report from the National Academy of Medicine to make recommendations for modernizing newborn screening initiatives.”
AACC CEO Janet B. Kreizman added:
“We would like to thank Representatives Roybal-Allard and Simpson for introducing this important legislation, which is critical to ensuring the health of the more than 4 million infants born in the U.S. each year. Newborn screening is one of the most successful public health programs of our time, and federal involvement plays a crucial role in both maintaining and advancing this initiative.”
In a 2014 article in Law and the Public’s Health, researchers wrote that some newborn screening tests may be controversial due to concerns about costs, religious freedom and privacy:
“[T]ests may be more controversial, however, based on their cost, reliability, and predictive value, as well as the availability and success of treatment. This uncertainty about testing technology in a newborn context contributes to variation in both health care practice and state policy standards. Even when the correct standard is clear, it can take a long time for public policy to catch up with technology. When the standard of care itself is uncertain, variation in public policy can be even more pronounced. Furthermore, in the case of newborn testing, uncertainty in the science of predictive testing and treatment combines with issues of privacy and religious and cultural beliefs. Public health policy tends to intervene decisively when the science is sound and the resulting balance of interests around the protection of health is clear. As the scientific questions grow fuzzier, the balance of interests begins to shift as well. This is particularly true where the issue at hand involves the rights of parents to determine the course of medical care for their children.”
In a 2014 Newsweek article, Susan Scutti expounded on these concerns, writing that “many states have created biobanks funded by genetic material left over from our screening tests, and, even more surprising, our specimens may be used for purposes we do not fully understand or for which we have not granted informed consent.” At that time, Scutti wrote that while infants’ blood samples are retained for a couple of years at most, 12 states kept samples in biobanks for 21 years or longer to use the genetic information for research and analysis. In May 2018, CBS San Francisco reported that California was one of a handful of states that stores infants’ remaining blood spots indefinitely for research purposes, using a state-run biobank to do so.
In defense of California’s practice, Dr. Fred Lorey, former director of the California Genetic Disease Screening Program, explained that blood spot samples are invaluable to researchers “because these samples are needed to create new testing technology,” identify new diseases and improve current tests — all of which ultimately saves more babies. Additionally, Lorey notes that blood spots’ sale to researchers (at $20-40 per spot) allows the California Genetic Disease Program to be self-supporting, as required by regulations.
This bill passed the House Committee on Energy and Commerce with the support of 50 bipartisan cosponsors, including 34 Democrats and 16 Republicans.
This bill is endorsed by the American Academy of Pediatrics; American Association for Clinical Chemistry (AACC); American College of Medical Genetics and Genomics; Association of Maternal & Child Health Programs; Association of Public Health Laboratories; Cystic Fibrosis Foundation; Cure SMA; EveryLife Foundation for Rare Diseases; Expecting Health at Genetic Alliance; Hunter's Hope Foundation; Immune Deficiency Foundation; March of Dimes; Muscular Dystrophy Association; National Organization for Rare Disorders (NORD); and Parent Project Muscular Dystrophy (PPMD).
Of Note: In the U.S., newborn screening is a state-run program that identifies infants who may have genetic, metabolic or hearing disorders that may not be apparent at birth. If left untreated, these conditions can cause serious illness, lifetime disabilities and even death. In many cases, early diagnosis and treatment can prevent or lessen the severity of these conditions. Approximately 1 in every 300 newborns in the U.S. has a condition that can be detected through screening. Nationwide, it’s estimated that newborn screening leads to potentially life-saving early diagnoses for 5,000-6,00- children nationwide.
Before the original Newborn Screening Saves Lives Act was enacted in 2008, only 10 states and the District of Columbia required infants to be screened for a complete panel of recommended disorders. Additionally, there was no federal repository of information on the diseases. When the Newborn Screening Saves Lives Act was enacted, it:
- Established grant programs to provide education in congenital, genetic, and metabolic disorders;
- Established grant programs for training in newborn screening technologies;
- Established grant programs to coordinate follow-up care;
- Created an increase of consumer awareness and knowledge of family support services, research, and other resources in newborn screening;
- Improved laboratory quality standards;
- Developed a national contingency plan if a public health situation arises; and
- Established a central online clearinghouse for genetic conditions in newborns.
Today, 49 states and the District of Columbia screen for at least 31 of 35 recommended core conditions. Additionally, parents and medical professionals have access to a central database of newborn screening information when a baby is diagnosed with one of these disorders.
However, Rep. Roybal-Allard’s office notes, “critical gaps and challenges still remain,” as the number of tests given from state to state vary widely and approximately 1,000 infants either die or are permanently disabled each year due to treatable disorders that’d have been caught with newborn screening.
Reps. Roybal-Allard and Simpson were the original cosponsors of the Newborn Screening Saves Lives Act, which was passed and signed into law in 2008 and last reauthorized in 2014.
Summary by Lorelei Yang(Photo Credit: iStockphoto.com / chameleonseye)