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Letters to the Secretary, U. S. Department
of Health and Human Services
DEPARTMENT OF HEALTH &
HUMAN SERVICES
ADVISORY COMMITTEE ON HERITABLE DISORDERS AND GENETIC
DISEASES IN NEWBORNS AND CHILDREN
The Honorable Michael O. Leavitt
Secretary of Health and Human Services
200 Independence Avenue, S.W.
Washington, DC 20201
Dear Secretary Leavitt:
In 2001, the Health Resources
and Services Administration (HRSA), Bureau of Maternal and Child Health, contracted
with the American College of Medical Genetics (ACMG) to convene an expert group
to review available information on newborn screening and to make recommendations
based on the best scientific evidence and analysis of that information to strengthen
State-based newborn screening programs in this country. The report from ACMG
contains a summary of the project, a review of the current and future landscape
of newborn screening, the process used for the expert group's analysis and the
expert group's recommendations. The report also describes the decision making
algorithm used by the expert group and outlines recommendations for a minimum
uniform panel of conditions for screening in State newborn screening programs.
In January 2005, the Advisory Committee on Heritable Disorders and Genetic Diseases
in Newborns and Children (Committee) reviewed and discussed the final report
and recommended the report be released to the public and agreed to review the
public comments and provide advice to the Secretary on those comments and the
report.
On March 8, 2005, HRSA announced a 60 day public comment period on the report
through publication of a Federal Register notice. The 60-day public comment
period has ended and the Committee has reviewed the public comments in the ACMG
report sent to HRSA.
The Committee notes that the majority of comments were favorable to the report
and its findings. Almost all of the comments supported the notion of using a
uniform panel in state newborn screening programs. Upon review of the final
report and the public comments to that report, the Committee is satisfied with
the work of the ACMG expert panel, its methodology, its findings and its recommendations
and again endorses the report and its recommendations.
However, the Committee notes that there were a few but significant concerns
raised by some of the commentators about the methodology used by the expert
panel. The Committee has reviewed that methodology with experts and has found
the methodology satisfactory and that the concerns about the methodology do
not negate the findings of the ACMG expert panel. The Committee concludes that
the report and its findings are based on the best methodology available at this
time. The Committee recognizes that analysis and evaluation is a dynamic process,
and therefore, the methodology used by this Committee for its own work in recommending
conditions, tests and technologies will evolve over time.
The Committee also realizes that there were some concerns from commentators
about issues the ACMG expert panel did not address in detail although the report
did note their importance. Many commentators, as did the ACMG expert panel,
emphasized the importance
of placing newborn screening within the context of our health care system and
to view it as a system: that is, newborn screening is more than a test. Newborn
screening includes not only the screening test, but importantly follow-up, diagnosis,
management and treatment, evaluation, and education. In addition, commentators
indicated:
- Access to health care
services should be addressed, such as supporting systems to facilitate connection
to the medical home for infants identified as screened positive,
- A need for organized
information systems to allow for the collection and analysis of relevant health
information about screen positive newborns.
- The definition and implementation
of a process within the Committee for evaluating and recommending conditions,
tests and technologies to be used in newborn screening programs.
- With expansion of newborn
screening many financing issues need to be considered, including costs of
care and treatments such as medical foods and formulas; cost of newborn screening
expansion; and the cost of the newborn screening system.
- Newborn screening processes
need to be standardized to bring more uniformity and equity to the newborn
screening system.
The Committee has begun
to examine and address many of these issues through the formation of subcommittees
on laboratory standards and procedures, education and training, and follow-up
and treatment.
In conclusion, the Committee strongly and unanimously recommends that the Secretary
initiate appropriate action to facilitate adoption of the ACMG recommended screening
panel by every State newborn screening program.
Sincerely yours,
R. Rodney Howell, M.D. Chairperson
ACHDGDNC
DEPARTMENT
OF HEALTH & HUMAN SERVICES |
-RECEIVED
""
Jun 13,2005 14 57:36 WS# 06
OFFICE OF THE SECRETARY
CORRESPONDENCE CONTROL
CENTER |
The Honorable Michael O.
Leavitt
Secretary of Health and Human Services
200 Independence Avenue, S. W.
Washington, DC 20201
Dear Secretary Leavitt:
The Advisory Committee on
Heritable Disorders and Genetic Diseases in Newborns and Children (the Committee)
held their second meeting on September 22-23, 2004. One of the central tasks
of this meeting was to review a draft report to the Health Resources and Services
Administration (HRSA) on newborn screening from the American College of Medical
Genetics (ACMG).
In 2002, the Maternal and
Child Health Bureau (MCHB) of HRSA commissioned ACMG to review available information
on newborn screening and to make recommendations based on the best scientific
evidence for strengthening State based newborn screening programs in the country.
The ACMG report contains a summary of the project, a review of the current and
future landscape of newborn screening, the process used for the expert group's
analysis and the expert group's recommendations. At the September meeting, a
draft of the report was shared with the Committee for their review and comments.
The Committee met again
on January 13 and 14, 2005 and received an update that the report was in a final
form (The Committee has not yet reviewed the final report.). The Committee made
the following recommendations, with a unanimous vote:
- The ACMG report to HRSA
be sent to the Secretary of Health and Human Services
under Chairman Howell's signature on behalf of the Committee.
- The ACMG report be released
into the public domain as soon as possible for review
and comment.
- The Committee review,
report, and make comments on the report as a Committee during the public comment
period.
- The Committee provides
advice to the Secretary on the public comments received by the Secretary.
A copy of the meeting summary and the public comments made at
the September meeting are included for your review. Please know that the Committee
stands ready to be of service to you to help strengthen newborn screening programs.
Effective newborn screening programs play a significant role in improving the
health of our Nation's children.
Sincerely yours,
R. Rodney Howell, M.D.
Chairperson
ACHDGDNC
Enclosures (1):
Tab A: Meeting Summary and Public Comments of the 2°d ACHDGDNC Meeting,
September 22-23, 2004
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