Dear Chairman Alexander,

Thank you for your consideration of the privacy issues concerning newborn screening and the issues surrounding state government storage, use and sharing of the newborn’s dried blood spots (DBS). We greatly appreciate that you have added language to the Newborn Screening Saves Lives Reauthorization Act of 2019 that will require parent consent for the use of DBS— newborn DNA—in federally funded research.

Most states conduct newborn (genetic) screening on every newborn within 48 hours of birth. After delivery, a few drops of blood from the baby’s heel are squeezed onto a card with special filter paper, sent to the state’s public health laboratory and tested for all or most of the 35 genetic conditions recommended by a national panel. While most parents who know about the program – many don’t – support newborn screening, most do not understand it is a government genetic testing program or that the newborn’s dried blood spots and test results can be used and shared without parental consent for purposes beyond newborn screening.

These blood spots contain the private genetic makeup of the baby and should not be shared or used, without parental consent, for research or other purposes. Yet today, California is selling newborn DNA to researchers for about $20 to $40 per blood spot. And the state of Indiana has given researchers access to 666 banker boxes of DBS (newborn DNA) collected from babies born over a 23-year period. Many of these children are now adults. No consent is required.

When parents discover that their child’s DNA has been stored by the state, shared and used by researchers, they often sue. To date, parents in Minnesota and Texas have filed lawsuits and won. Parents in Michigan are currently pursuing a case against the state’s biobank and have won a recent victory in federal court.

Newborns cannot protect themselves from genetic analysis and exploitation. Congress was right in 2014 to protect these newborn citizens by adding a parental consent requirement to the Newborn Screening Saves Lives Reauthorization Act of 2014 (plus language acknowledging the use of DBS as research on human subjects) with the understanding that these protections would be included in the final Common Rule, which governs federally-funded research. Unfortunately, the final Common Rule, issued on the last day of the previous administration, specifically eliminated the parental consent requirement. 

Thus, we appreciate your support for making these privacy and parental consent protections a permanent part of federal law. The genetic privacy rights of the four million babies born in America each year are at stake. 

Please consider the information attached to this letter as you work with members of your committee to finalize the Newborn Screening Saves Lives Reauthorization Act of 2019. 

On behalf of the undersigned organizations, we thank you for your attention to this critical genetic privacy issue and your strong support for requiring parental consent for the use of newborn DNA by federally-funded researchers. 

Sincerely, 

Twila Brase, RN, PHN
President and Co-founder
Citizens' Council for Health Freedom

Jake Duesenberg
President
Action 4 Liberty

William J. Olson
General Counsel
Center for Medical Freedom

Kristin Held, MD
President
Association of American Physicians and Surgeons

Kim Crockett
Vice President & General Counsel
Charlemagne Institute

Sandy Rios
Director of Governmental Affairs
American Family Association

Lawrence D. Pratt
President
Conservative Legal Defense and Education Fund

Bab Carlstrom
President
AMAC Action

Carol Stopps
President
Conservative Legislative Information Council of Virginia (CLIC-VA)

Dean Clancy
Senior Policy Fellow, Health Care
Americans for Prosperity

Nicole Theis
President
Delaware Family Policy Council

Andrew F. Quinlan
President
Center for Freedom and Prosperity

Katarina Lindley, DO, FACOFP
Board Trustee
DPC Action

Eunie Smith
President
Eagle Forum

John Helmberger
Chief Executive Officer
MN Family Council

Bob McEwen
US House of Representatives
Fmr. Member, Ohio

Dr. Allen Unruh
President
National Abstinence Clearinghouse

Lawrence W. Reed
President Emeritus
Foundation for Economic Education

Jason J. McGuire
President
New Yorker's Family Research Foundation

Jason Pye
Vice President of Legislative Affairs
FreedomWorks

CL Gray, MD
President
Physicians for Reform

Kimberly Legg Corba, DO
President
Pennsylvania Direct Primary Care Association

Judith Thompson, MD
Marion Mass, MD
Westby Fisher, MD
Practicing Physicians of America

Mario H. Lopez
President
Hispanic Leadership Fund

Jake Hoffman
President and CEO
Rally Forge

Beverly Gossage
President and Founder
HSA Benefits Consulting

Norm Singleton
President
Ron Paul's Compaign for Liberty

Heather R. Higgins
CEO
Independent Women's Voice

Jenny Beth Martin
Honorary Chairman
Tea Party Patriots Action

Merril Matthews, Ph.D
Resident Scholar
Institute for Policy Innovation

James Taylor
President
The Heartland Institute

Jordan Roberts
Health Policy Analyst
John Locke Foundation

Roger Stark, MD, FACS
Health Care Analyst
Washington Policy Center

Ginni Thomas
President
Liberty Consulting