September 22, 2004
Washington, D.C.

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First, let me begin by welcoming the members of Advisory Committee on Heritable Disorders and Genetic Diseases in Newborns and Children.
 
I am happy to see you again, so soon after we all met at the first meeting of the committee in June.
 
Dr. Rodney Howell of the University of Miami School of Medicine, thank you again for serving as chair of the committee.
 
Dr. Peter van Dyck, HRSA Associate Administrator for Maternal and Child Health, is HRSA’s representative to this committee.  Thank you, Peter, for your leadership in these issues and your counsel to HRSA Administrator Betty Duke and me.  Most of HRSA’s genetics programs, of course, reside in Peter’s bureau.
 
The Federal government’s maternal and child health experts have been involved with  newborn screening issues since the days of the Children’s Bureau -- long before there was a HRSA; long before there was a U.S. Department of Health and Human Services.
 
In 1962, after Dr. Robert Guthrie devised a practical system for collection and transportation of blood samples, Federal MCH experts supported the field trial for the phenylketonuria (PKU) test.   The field test eventually involved 400,000 infants in 29 states.  Soon thereafter, state laws mandating newborn screening became the foundation of HRSA's current genetics program.
 
Our concern now is that recent advances in technology have left a patchwork of screening standards in states across America.  States, of course, are responsible for their own newborn screening programs: the Federal government cannot impose standards on them.   But we can issue guidelines, which, as members of the advisory committee, you are here to help us do.
 
Your work is to advise us on steps states can take to assure that all American children receive a top-rate standard of care.  A child born in one state deserves the same basic standard of care as a child born on the other side of a state border.  Currently, differences in screening among states result in great inequity for parents.
 
We know that improving testing is an issue of paramount importance to parents.  To make sure their voices are represented, we have set aside a period for public comments tomorrow.  Parents who are unable to testify can send in letters that will become part of the official testimony of the committee.
 
The issue of equity for parents and their children is not confined just to the screening tests themselves.  Equity also must include the service infrastructure that is a necessary part of the entire newborn screening system. 
 
We also ask Committee members to weigh in on other crucial issues.  Among the most important of these is cost.  Testing incurs its own expense, and after-test costs to track patients and consult experts add to the expense.  We urge you to find a balance between cost and the need to do comprehensive testing.  These are difficult lines to draw, and we welcome your advice.
 
We also ask your advice on issues of privacy and ethics.  Newborn screening presents many ethical dilemmas and more will come as technology evolves.  Ethics and privacy issues need to be considered strongly in this debate.
 
Very shortly you will be briefed by Michael Watson from the American College of Medical Genetics on the draft report that was commissioned by HRSA.  The report assembles the available information on newborn screening, reviews the best scientific evidence, and presents options for model policies and procedures.
 
We ask you to analyze it and give us your advice.  Your work will inform and encourage a dialogue with MCH state directors and others.  Once that process concludes, HRSA will make recommendations to Secretary Thompson on the guidelines we feel states should follow to improve their newborn screening programs.  This is an important topic and a high priority for HRSA.  We plan to move quickly on it.
 
However, please note that the report itself is considered an internal document until the full process is concluded.  Discussion in this meeting about its contents becomes part of the public debate, but the report will not be made public until the Department prints and distributes it.
 
I don’t really need to emphasize the importance of the committee’s work to help us improve newborn screening services.  Your recommendations will literally have life-or-death implications for children and their families across America.  Newborn screening also is the focus of increasing interest from the press and the public at large.
 
We are very confident that your knowledge and expertise will help us recommend guidelines to Secretary Thompson that will greatly benefit children and their families across the United States, and we thank you for your participation.
 
Thank you.