The House June 24 passed a bill to reauthorize a program aimed at preventing newborn deaths and severe disabilities through the increased use of comprehensive and standardized newborn screening tests.
The proposed Newborn Screening Saves Lives Reauthorization Act of 2014 (H.R. 1281) would extend for five years a program administered by the Health Resources and Services Administration in the Department of Health and Human Services (HHS) to provide screening, counseling, and other services related to heritable disorders. It also would expand the program to include evaluation of the treatment and follow-up care provided for newborns and their families after screening and diagnosis.
The bill would continue the Hunter Kelly Newborn Screening Program, which helps researchers at the National Institutes of Health to develop better detection, prevention, and treatment strategies. The program is named after the son of Pro Football Hall of Fame quarterback Jim Kelly, who died at age 8 in 2005 of a rare, fatal genetic disorder affecting the nervous system.
The House passed the bill though a voice vote.
“By passing the Newborn Screening Saves Lives Reauthorization Act, the House has reaffirmed the importance of ensuring that babies continue to receive a comprehensive and consistent set of screening tests, and giving parents and professionals centralized access to newborn screening information,” bill sponsor Lucille Roybal-Allard (D-Calif.) said in a June 24 statement.
Roybal-Allard also introduced the original legislation, the Newborn Screening Saving Lives Act of 2007 (Pub.L. 110-204). Before the original law was enacted in 2008, Roybal-Allard said, just 10 states and the District of Columbia required infants to be screened for a complete panel of recommended disorders, and there was no federal repository of information on the diseases. Today, she said, 44 states and the District require screenings for 29 of the 31 core treatable conditions, and parents and professionals have access to a central database of newborn screening information when a baby is diagnosed with one of these disorders.
But Roybal-Allard said there are still discrepancies in the number of screening tests given from state to state, and about 1,000 infants face death or permanent disability each year as a result of what would have been treatable disorders. The 2014 reauthorization bill would help provide states with the resources they need to improve their newborn screening programs and to uniformly test for all recommended disorders. It also would provide states with assistance in developing follow-up and tracking programs, Roybal-Allard said.
The bill renews the Discretionary Advisory Committee on Heritable Disorders in Newborns and Children, which advises the HHS secretary on universal newborn screening tests, technologies, policies, guidelines, and standards. The Senate Jan. 29 passed a companion bill (S. 1417), sponsored by Sens. Kay Hagan (D-N.C.) and Orrin G. Hatch (R-Utah).
Privacy Concerns Raised
The Citizens’ Council for Health Freedom, a health freedom group based in St. Paul, Minn., described the legislation as supporting a “funding program that allows states to collect and store newborn DNA without parental consent.”
“In the name of public health, this legislation continues a program that strips parents of their right to have a say in who holds their child’s genetic code,
strips children of their privacy and property rights, and institutionalizes national data-sharing among federal and state governments,” Twila Brase, co-founder and president of the citizens’ council, said in a June 23
“It’s one thing for newborn blood samples to be tested for a specific set of newborn genetic conditions; it’s entirely another for the government to grant itself the right to store that data and those DNA samples indefinitely, to use them for genetic research without parental knowledge or consent, and to place virtual tracking devices on every child by following their health history into adolescence. Yet, these are exactly what this bill does,” Brase said.
In response to a request for comment, Roybal-Allard said that newborn screening is voluntary. “Parents have the option of opting out of any tests that a baby may receive,” Roybal-Allard said in her e-mail. “And individual state laws, not federal laws, determine specific policies regarding these specimens.”
Natasha F. Bonhomme, vice president of strategic development at Genetic Alliance, which runs the newborn screening resource center (http://BabysFirstTest.org
), said reauthorization of the Newborn Screening Saves Lives Act will ensure that federal programs can continue to support state public health departments in their efforts to improve screening for all children, expand education and awareness efforts for parents and health professionals, and promote laboratory quality improvement. Bonhomme added that each state has its own newborn screening program and has particular protocols regarding the parents’ ability to opt out of screening, storage and use of residual specimens, and data-sharing.
“These practices aim to provide the highest quality of care, including the protection of privacy,” Bonhomme said. “This act has supported multiple initiatives that have examined parent perspectives and preferences regarding screening across the country. State programs can now use these findings to improve how they communicate with and connect to families. This funding allows for the development of best practices for continued newborn screening program advancements and renews the commitment to improving and protecting the health of all newborns.”
H.R. 1281 was received by the Senate for its consideration June 25.
Takeaway: Legislation reauthorizing a newborn screening program has met some resistance from privacy groups, which raise concerns about states being able to collect and store DNA without informed consent.