Nearly 100 GOP lawmakers send letter asking FDA for answers on prenatal screening

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Nearly 100 Republican lawmakers are demanding answers from the Food and Drug Administration (FDA) on the nature and validity of noninvasive prenatal testing (NIPT).

Rep. Chip Roy, R-Texas, Sen. Steve Daines, R-Mt., and Rep. Michelle Fischbach, R-Minn., along with more than 90 colleagues in both houses, sent the letter to the federal agency on January 21.

Lawmakers addressed the letter to Acting Food and Drugs Commissioner Janet Woodcock.

“We are writing to you today because we understand 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,” reads -on in the letter.

Rep. Chip Roy (R-TX), joined by Rep. Marjorie Taylor Greene (R-GA), speaks during a press conference on the National Defense Authorization Bill at the States Capitol States on September 22, 2021 in Washington, DC
(Kevin Dietsch)

EXPERTS WARN PRENATAL SCREENING TESTS MAY LEAD TO FALSE POSITIVE RESULTS IN SOME CASES

The letter is in response to a New York Times article that claims that 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 from these tests are incorrect about 85% 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, non-invasive prenatal tests detect the fetus’ risk of common chromosomal conditions, including trisomy 21 (Down’s syndrome), trisomy 18 (Edwards’ syndrome), and trisomy 13 (Patau’s syndrome).

The tests have now expanded to be used to detect other rare chromosomal diseases and conditions associated with chromosomal microdeletion disorders, according to several reports. Depending on the disorder, the accuracy of the test can vary, experts say.

Republican congressional candidate Michelle Fischbach speaks during a rally for President Donald Trump at Bemidji Regional Airport on September 18, 2020 in Bemidji, Minnesota.

Republican congressional candidate Michelle Fischbach speaks during a rally for President Donald Trump at Bemidji Regional Airport on September 18, 2020 in Bemidji, Minnesota.
(Stephen Maturity/Getty Images)

At the end of the letter, 13 questions ask for more information about the test approval process, monitoring of test quality, and data on “which (if any) prenatal genetic screening tests are approved by the FDA”. Lawmakers say these responses must be answered “to protect vulnerable populations like people with disabilities, pregnant mothers and their unborn children.”

REPUBLICAN POLITICIANS CALL FOR ACTION AGAINST BIOTECH COMPANIES AFTER REPORT ON PRENATAL TEST FAILURES

The results of non-invasive prenatal tests are often used by parents to prepare for the birth of their child. However, lawmakers “fear they could constitute a predatory financial boon to manufacturers and directly result in the death of innocent human lives.”

According to a 2017 to study published by the National Center for Biotechnology Information, the Singapore Clinical Service found that “of the 33 confirmed cases of DS (Down’s Syndrome) following invasive testing or high-risk NIPT with known results, 29 had were interrupted (87.9%) and 4 (12.1%) continued with 1 stillbirth.”

The doctor examines the belly of the pregnant woman for the checkup of the baby and the mother.

The doctor examines the belly of the pregnant woman for the checkup of the baby and the mother.
(Stock)

The letter was sent and made public the same day that thousands of pro-life Americans took part in the 49th Annual Walk for Life in Washington, D.C. Roy attended the march and spoke with Fox News Digital on requests.

Roy said it was about saying “whether or not these [screenings] actually disseminate the right kind of information so that parents make good decisions rather than convincing them to abort on bad information.”

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Along with sending the letter, Roy said he pledged to stop taxpayer funding for organizations like Planned Parenthood, adding that the bureaucrats were “targeting our way of life.” But Roy added that there is still much to do outside the halls of Congress.

“My job as a congressman is to remind people that we still have to win minds and hearts,” he said. “We have a lot of work to do to make sure we fight and defend life.”

Fox News’ Amy McGorry contributed to this report.

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