Nearly 100 GOP lawmakers send letter demanding FDA provide answers on prenatal screening

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Nearly 100 Republican legislators are demanding answers from the Food and Drug Administration (FDA) on the nature and validity of non-invasive prenatal testing (NIPT). 

Rep. Chip Roy, R-Texas, Sen. Steve Daines, R-Mt., and Rep. Michelle Fischbach, R-Minn., along with over 90 colleagues in both chambers, sent the letter 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.

Rep. Chip Roy (R-TX), joined by Rep. Marjorie Taylor Greene (R-GA), speaks at a news conference about the National Defense Authorization Bill at the U.S. Capitol on Sept. 22, 2021 in Washington, D.C. (Kevin Dietsch)

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

The letter is in response to a New York Times 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, according to multiple 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 the Bemidji Regional Airport on Sept. 18, 2020 in Bemidji, Minnesota. (Stephen Maturen/Getty Images)

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 "which (if any) 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."

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

The results of non-invasive prenatal testing are often used by parents to prepare for the birth of their child. However, the lawmakers are "concerned that they could be a predatory financial windfall for manufacturers and directly result in the termination of innocent human life." 

According to a 2017 study published by the National Center for Biotechnology Information, clinical service in Singapore found that "from the 33 cases with confirmed DS (Down Syndrome) following invasive testing or high risk NIPT where outcomes were known, 29 terminated (87.9%) and 4 (12.1%) continued with 1 being stillborn."

Doctor examines pregnant belly for the baby and mother's health check up. (iStock)

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 in Washington, 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 [screenings] 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."

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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," he said. "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.