Newborn Screening Saves Lives Act of 2007

This bill, S. 1858, was a bipartisan bill sponsored by Sen. Chris Dodd, Sen. Orrin Hatch, and Sen. Hillary Clinton. It passed the U.S. Senate by unanimous consent on December 13, 2007. The bill passed the House of Representatives of the United States by Voice Vote on April 8, 2008. President George W. Bush signed the bill into law 16 days later. This legislation was first introduced as the Newborn Screening Saves Lives Act of 2002 in the second section of the 107th United States Congress. Senator Chris Dodd (D-CT) and Representative Lucille Roybal-Allard sponsored the bill in the U.S. Senate and House of Representatives of the United States, respectively. Like most new legislation, S. 2890 and H.R. 4493 garnered minimal support and received no further action after being referred to the Senate Committee on Health, Education, Labor, and Pensions, and the House Subcommittee on Health.

The Newborn Screening Saves Lives Act was again introduced in subsequent sessions of Congress. The bills were introduced as S. 1068 and H.R. 4493 in the 108th United States Congress, S. 2663 and H.R. 5397 in the 109th United States Congress, and S. 1634 and H.R. 1634 in the first session of the 110th United States Congress. During the 110th United States Congress, the Newborn Screening Saves Act was reintroduced as S. 1858 after S. 1634 was combined with the competing legislation, the Screening for Health of Infants and Newborn Act [S. 1712] sponsored by Senator Hillary Clinton (D-NY). With this merge, Senator Chris Dodd (D-CT), Senator Hillary Clinton (D-NY), Senator Orrin Hatch (R-UT), and Senator Edward Kennedy (D-MA) led the way on this bill, which became the Newborn Screening Saves Lives Act that was ultimately passed and signed into law. The companion bill was H.R. 3825.[3]

The Newborn Screen Saves Lives Act (NBSSLA) expanded the authorizations and duties of the Health Resources and Services Administration in dealing with newborn screening. This legislation has allowed HRSA to spearhead the creation of federal recommendations on newborn screening, and assists State programs in meeting these requirements. It also facilitates the establishment of grant programs to support education and outreach initiatives to increase adoption and knowledge of newborn screening. Furthermore, it gives HRSA the power to establish, maintain, and operate a system designed to evaluate and manage treatments concerning congenital, genetic, and metabolic disorders.

On April 24, 2008, programs and activities were expanded by the "Newborn Screening Saves Lives Act of 2008" to facilitate the creation of Federal guidelines on newborn screening, assist State newborn screening programs in meeting federal guidelines, and establish grant programs to provide for education and outreach on newborn screening, and implement coordinated follow-up care once newborn screening has been conducted.

While this legislation has received strong support from the medical community, and patient advocacy groups, there has been continued opposition to its mandates. Most notably, the Citizen's Council on Health Freedom strongly opposed the passage of NBSSLA over privacy concerns. Twila Brase, the president of the Minnesota based activist group, voiced concerns over the storage of bloodspots, and is a strong proponent of having all bio-banks destroyed. Brase cited concerns over "government-sponsored genetic research." It is worth noting that states have been storing samples since the 1960s when NBS was first implemented, and each state has its own policy on DBS storage and research. As of 2008, California has stored over 12,000 samples since 1980, while Texas destroys the samples within months. Privacy advocacy groups voiced concerns on the potential abuse of these samples in both medical and forensic uses. Some have cited the sharing of genetic information with the Department of Homeland Security . However, past practices and clear policies on use and limitations indicate that there is a distinct separation between medical and forensic use. State laboratories have been known to turn down requests from law enforcement to access NBS data and samples, even in cases for the identification of missing children.

The legislation has allowed newborn screening to be enhanced and expanded, and has also established federal guidelines for conditions all newborns should be screened for. Additionally, it has created a comprehensive, public-facing, educational repository on newborn screening in the form of Baby's First Test.[6] This funding has increased the awareness among parents and health professionals. Since the passage of NBSSLA, the Secretary Advisory Committee on Heritable Disorders in Newborns and Children has added Severe Combined Immunodeficiences (SCID) and Critical Congenital Heart Disease (CCHD) to the Recommended Uniform Screening Panel (RUSP).

NBSSLA funding was also key to enhancing programs within the Regional Genetic and Newborn Screening Service Collaboratives, along with the National Coordinating Center for the Collaborative. By November 30, 2010, every state and territory had the ability to enter positively screened newborns into their clinical management systems. This outcome is a 7% improvement from the 93% figure from December 2008 when the evaluation first occurred.

The Newborn Screening Saves Lives Reauthorization Act of 2013 (H.R. 1281; 113th Congress) was introduced into the House of Representatives in 2013 in order to reauthorize this bill.[7]

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• Senate Report
• Senator Dodd’s Introductory Remarks