Privacy Issues Stall Newborn Screening Bill

by jeeg 1. December 2014 21:55


A bill that would support newborn screening nationwide has stalled in Congress because some Republican senators have privacy concerns about genetic research funded by the legislation.

The senators won’t comment individually, but the Senate Steering Committee has indicated it wants a provision added to the bill to require parental consent before genetic research and genomic sequencing could be done on a child’s newborn screening sample.

Nearly every baby in the country is tested for genetic disorders shortly after birth. Blood is collected on a card that is sent to state public health labs for testing, in order to identify conditions that are often easily treatable. The cards are often later used anonymously for research. The senators holding up the bill believe that a child could be identified from such research.

Newborn-screening advocates have said they are willing to discuss ways to more clearly define and limit research but are worried that the focus on the research — just one part of the bill — will derail it from becoming law before Congress ends its lame-duck session this month.

“We certainly hope we don’t have to start this process over from scratch in 2015 — this issue is far too important for infants and families,” said Cynthia Pellegrini, senior vice president at the March of Dimes, one of several advocacy groups supporting the Newborn Screening Saves Lives Reauthorization Act.

The bill, which involves $19.9 million in spending, would reauthorize a 2008 measure that funds many programs supporting the country’s state-run newborn screening systems. Newborn screening will still continue in all states even if the bill does not pass — as each state operates its own program — but amendments to the bill would not be instituted.

This year both the House and Senate added timeliness measures to the bill after a Milwaukee Journal Sentinel investigation in November 2013 found that thousands of hospitals were sending babies’ blood samples late to state labs.

Those changes will require that experts systematically track and improve the timeliness of newborn screening programs nationwide. The Journal Sentinel found that newborn screening varies widely in quality depending on the state or hospital where a child is born. Other amendments made to the bill include:

∎ The U.S. Centers for Disease Control and Prevention would be directed to evaluate laboratory quality and surveillance activities, with a focus on timeliness, so state labs can collect and share standardized data.

∎ The Government Accountability Office, the investigative arm of Congress, would be required to prepare a report within two years that examines the timeliness of newborn screening throughout the country, while also summarizing guidelines, recommendations and best practices to support a timely newborn screening system.

∎ A committee of experts that advises the U.S. Health and Human Services secretary would be directed to provide recommendations on improving timeliness in newborn screening programs.

If the bill does not pass in December, funding for that committee would run out in the spring. A new sponsor in the Senate would also be needed, as U.S. Sen. Kay Hagan, D-N.C., was defeated in the November election.

Ellen Gabler, Milwaukee Journal Sentinel


Comments are closed
Log in