担当者. Chip Roy, R-テキサス, その. Steve Daines, R-Mt., および担当者. Michelle Fischbach, R-Minn., along with over 90 colleagues in both chambers, sent the 文字 to the federal agency on Jan. 21.
The legislators addressed the letter to Acting Commissioner of Food and Drugs Janet Woodcock.
“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,” the letter read.
The letter is in response to a ニューヨーク・タイムズ article that claims the tests, which are used to detect the risk of a fetus having rare genetic abnormalities, often result in false positives. According to the article, a recent study shows that “positive results on those tests are incorrect about 85 percent of the time.”
Screenings such as NIPT are used to detect chromosomal disorders caused by the presence of an extra or missing copy (aneuploidy) of a chromosome, according to health experts. Primarily, noninvasive prenatal testing detects the fetus’ risk for common chromosomal conditions, including trisomy 21 (Down syndrome), trisomy 18 (Edwards syndrome) and trisomy 13 (Patau syndrome).
The tests have now expanded to being used to detect some other rare chromosomal diseases and conditions associated with microdeletion chromosomal disorders, 複数の報告によると. Depending on the disorder, the accuracy of the test can vary, 専門家は言う.
Included at the end of the letter are 13 questions asking for more information regarding the approval process of the tests, oversight of the quality of the tests and data on “これ (もしあれば) of the prenatal genetic screening tests are FDA approved.” The legislators state these answers need to be answered “to protect vulnerable populations like persons with disabilities, pregnant mothers, and their unborn children.”
The results of non-invasive prenatal testing are often used by parents to prepare for the birth of their child. しかしながら, the lawmakers are “concerned that they could be a predatory financial windfall for manufacturers and directly result in the termination of innocent human life.”
によると 2017 調査 published by the National Center for Biotechnology Information, clinical service in Singapore found that “から 33 cases with confirmed DS (Down Syndrome) following invasive testing or high risk NIPT where outcomes were known, 29 本を読む行為を倫理違反として位置付けることにおいて (87.9%) そして 4 (12.1%) continued with 1 being stillborn.”
The letter was sent and released to the public the same day thousands of pro-life Americans participated in the 49th annual March for Life ワシントンで, D.C. Roy attended the march and spoke with Fox News Digital about the demands.
Roy said it’s a matter of telling “whether or not those [スクリーニング] are actually putting out the right kind of information for parents to make good decisions rather than actually convincing them to abort on bad information.”
Aside from sending the letter, Roy said he is committed to stopping taxpayer funding for organizations like Planned Parenthood, adding that bureaucrats are “targeting our way of life.” But Roy added that much more needs to be done outside the halls of Congress.
“My job as a member of Congress is to remind people that we need to still win minds and hearts,” 彼は言った. “We have a lot of work to do to make sure we’re fighting and defending life.”
Fox News’ Amy McGorry contributed to this report.