THE HILL
Republican lawmakers sent a letter to the Food and Drug Administration (FDA) seeking answers about noninvasive prenatal tests after learning that many such tests are inaccurate.
At the beginning of the year, The New York Times published an investigation that said the five most common prenatal tests screening for conditions via missing chromosome pieces called microdeletions show false positives 85 percent of the time.
These microdeletion tests screen for a number of less common conditions, including DiGeorge syndrome and Wolf-Hirschhorn syndrome, according to The Times. The newspaper found that some companies don’t post data for the accuracy of their tests and still market them as “highly accurate.”
The Times reported that the FDA does not regulate these kinds of prenatal tests.
The letter sent to Acting FDA Commissioner Janet Woodcock, led by Rep. Chip Roy (R-Texas) and Rep. Michelle Fischbach (R-Minn.), seeks answers about how much control the FDA has over the prenatal test and if the agency plans to take action following the Times report.
More than 90 Republicans signed onto the letter, which was obtained by The Hill. It included a list of 13 questions to “seek further clarification from the agency on this important matter.”
The letter asks how knowledgeable the FDA is on this matter, what type of regulation the tests are under and what actions the FDA can or will take, among other items. It also requests data on FDA-approved prenatal tests.
“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,” the letter states.
The Hill has reached out to the FDA for comment.
