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  • Roy-Daines-Fischbach Pro-Life Letter To FDA On NIPT

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    Mary Margaret Olohan
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    Members of Congress wrote to the FDA Acting Commissioner to express concerns about the high rate of false positives from non-invasive prenatal tests (NIPT) as reported by The New York Times. They note many NIPT tests have not been approved by the FDA and request clarification on the FDA's oversight. The letter asks 13 questions regarding the FDA's awareness of test accuracy issues, review and approval processes, labeling requirements, and potential actions to regulate NIPT tests.

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    Roy-Daines-Fischbach Pro-Life Letter to FDA on NIPT

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    Roy-Daines-Fischbach Pro-Life Letter to FDA on NIPT

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    Members of Congress wrote to the FDA Acting Commissioner to express concerns about the high rate of false positives from non-invasive prenatal tests (NIPT) as reported by The New York Times. They note many NIPT tests have not been approved by the FDA and request clarification on the FDA's oversight. The letter asks 13 questions regarding the FDA's awareness of test accuracy issues, review and approval processes, labeling requirements, and potential actions to regulate NIPT tests.

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    15K views10 pages

    Roy-Daines-Fischbach Pro-Life Letter To FDA On NIPT

    Uploaded by

    Mary Margaret Olohan
    Members of Congress wrote to the FDA Acting Commissioner to express concerns about the high rate of false positives from non-invasive prenatal tests (NIPT) as reported by The New York Times. They note many NIPT tests have not been approved by the FDA and request clarification on the FDA's oversight. The letter asks 13 questions regarding the FDA's awareness of test accuracy issues, review and approval processes, labeling requirements, and potential actions to regulate NIPT tests.

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    of 10

    January 21, 2022

    The Honorable Janet Woodcock


    Acting Commissioner
    United States Food and Drug Administration
    10903 New Hampshire Ave
    Silver Spring, MD 20993-0002

    Dear Acting Commissioner Woodcock,

    On January 1, 2022, The New York Times published a deeply troubling article highlighting the
    concerning high level of false-positive results from non-invasive prenatal testing (NIPT). 1 We
    write to you today because it is our understanding that many of these tests have not been approved
    by the Food and Drug Administration (FDA), and we seek further clarification from the agency on
    this important matter.

    While breakthroughs in genetic sequencing have provided Americans and their health care
    providers with new tools, there must be proper oversight of these new technologies to protect
    vulnerable populations like persons with disabilities, pregnant mothers, and their unborn children.
    NIPT became commercially available in the U.S. in 2011 as a screening tool to analyze DNA in a
    mother’s blood to estimate the likelihood that her child will be born with certain genetic
    abnormalities. 2 Since then, the prevalence of NIPT has steadily increased, and several NIPT
    options are currently recommended by the American College of Obstetricians and Gynecologists
    (ACOG) and American College of Medical Genetics (ACMG) for use by pregnant women.
    Although the NIPT industry now performs tests on more than one-third of all pregnant women in
    the U.S., 34 NIPT has largely escaped FDA regulatory review.

    Companies that market and sell these products continue to see their profits grow and more products
    enter the market. According to a Pew Trust report from January of 2021, more than 40 non-invasive
    prenatal tests are now available on the market. 5 Unfortunately, many of the test manufacturers do
    not publish data on the accuracy of their tests, and others point to less than satisfactory studies to
    support their products. 6

    An examination of NIPT by The New York Times casts doubt on the efficacy of these tests.
    According to analysis conducted by The New York Times, positive results on certain tests were
    incorrect approximately 85 percent of the time. This is particularly troubling as NIPT is often

    1
    https://www.nytimes.com/2022/01/01/upshot/pregnancy-birth-genetic-testing.html
    2
    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4303457/pdf/ijwh-7-113.pdf
    3
    https://www.nytimes.com/2022/01/01/upshot/pregnancy-birth-genetic-testing.html
    4
    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4303457/pdf/ijwh-7-113.pdf
    5
    https://www.pewtrusts.org/-/media/assets/2021/01/clinical_lab_tests_need_stronger_fda_oversights.pdf
    6
    https://www.nytimes.com/2022/01/04/podcasts/the-daily/prenatal-tests-pregnancy-birth.html?showTranscript=1
    recommended to parents as a way of detecting certain rare disorders such as DiGeorge syndrome,
    1p36 deletion, Cri-du-chat syndrome, Wolf-Hirschhorn syndrome, and Prader-Willi and
    Angelman syndromes. While these tests can help parents prepare for the arrival of their child, we
    are concerned that they could be a predatory financial windfall for manufacturers and directly
    result in the termination of innocent human life.

    We respectfully request a response to the following questions related to non-invasive prenatal tests:

    1) Is the FDA aware of the efficacy of these tests as reported by The New York Times and
    validated in published literature such as The New England Journal of Medicine and
    Prenatal Diagnosis? 789
    2) To what extent and under what circumstances does the FDA review the safety and efficacy
    of these tests?
    3) What additional tools or authorities does the FDA need to evaluate and review the efficacy,
    including the validity, of these tests?
    4) If the FDA is aware of a safety concern regarding tests currently on the market, what
    authority, if any, allows the FDA to take action on such tests?
    5) What, if any, labeling requirements does the FDA require for these tests regarding safety
    or efficacy and the likelihood of potential adverse events?
    6) How does the approval process differ between laboratory developed tests and medical
    devices?
    7) Why are non-invasive prenatal tests regulated through the laboratory developed tract rather
    than the medical device tract?
    8) Is the FDA considering evaluating the accuracy of claims made by the manufacturers of
    non-invasive prenatal tests?
    9) Is the FDA considering requiring that manufacturers report adverse outcomes related to
    non-invasive prenatal tests?
    10) Is the FDA considering taking any action to monitor the quality of non-invasive prenatal
    tests?
    11) What data, if any, is the FDA examining or collecting related to non-invasive prenatal
    tests?
    12) What steps can the FDA take to regulate non-invasive prenatal tests through department
    action?
    13) Can you please provide us with data regarding which (if any) of the prenatal genetic
    screening tests are FDA approved?

    Thank you for your attention to this issue.

    Chip Roy Steve Daines Michelle Fischbach


    Member of Congress U.S. Senator Member of Congress

    7
    https://pubmed.ncbi.nlm.nih.gov/24571752/
    8
    https://www.nejm.org/doi/full/10.1056/nejmoa1407349
    9
    https://pubmed.ncbi.nlm.nih.gov/26715197/
    Roger Marshall, M.D. Ben Sasse
    United States Senator United States Senator

    Jerry Moran Tom Cotton


    United States Senator United States Senator

    James E. Risch James M. Inhofe


    United States Senator United States Senator

    Jake Ellzey Jeff Duncan


    Member of Congress Member of Congress

    Steven M. Palazzo Jim Banks


    Member of Congress Member of Congress

    Mary Miller Randy Feenstra


    Member of Congress Member of Congress
    Alex X. Mooney Ronny L. Jackson, M.D.
    Member of Congress Member of Congress

    Jeff Fortenberry Tom Emmer


    Member of Congress Member of Congress

    Michael Guest Ralph Norman


    Member of Congress Member of Congress

    Don Bacon Lisa McClain


    Member of Congress Member of Congress

    Virginia Foxx Doug Lamborn


    Member of Congress Member of Congress

    Jim Jordan Adrian Smith


    Member of Congress Member of Congress
    Michael Waltz Bob Good
    Member of Congress Member of Congress

    Randy K. Weber Rodney Davis


    Member of Congress Member of Congress

    Robert B. Aderholt David B. McKinley, P.E.


    Member of Congress Member of Congress

    Glenn Grothman Jason Smith


    Member of Congress Member of Congress

    Andy Biggs Andrew Clyde


    Member of Congress Member of Congress

    Daniel Webster Markwayne Mullin


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    Doug LaMalfa Mike Johnson
    Member of Congress Member of Congress

    Scott Franklin Brian Babin, D.D.S.


    Member of Congress Member of Congress

    Ben Cline Robert E. Latta


    Member of Congress Member of Congress

    Marjorie Taylor Greene Jim Hagedorn


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    Tim Walberg Bill Johnson


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    Louie Gohmert Mike Bost


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    Pete Sessions Julia Letlow


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    Jody Hice Pete Stauber


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    John H. Rutherford Bob Gibbs


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    Jack Bergman August Pfluger


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    Jackie Walorski Lloyd Smucker


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    Chris Smith William R. Timmons


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    David Rouzer Bill Huizenga


    Member of Congress Member of Congress
    Lauren Boebert Brian Mast
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    Young Kim Tim Burchett


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    Blake Moore Mariannette J. Miller-Meeks, M.D.


    Member of Congress Member of Congress

    Steve Chabot Bill Posey


    Member of Congress Member of Congress

    Rob Wittman Vicky Hartzler


    Member of Congress Member of Congress

    Mo Brooks Glenn Thompson


    Member of Congress Member of Congress
    Scott DesJarlais Mike Carey
    Member of Congress Member of Congress

    Darin LaHood Roger Williams


    Member of Congress Member of Congress

    John Moolenaar John Joyce, M.D.


    Member of Congress Member of Congress

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    Member of Congress

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