Republicans Confront FDA Over Faulty Fetal Tests

CV NEWS FEED // Congressional Republicans on Friday pressed the Food and Drug Administration (FDA) to account for its involvement with, and authority over, non-invasive prenatal testing.

Reps. Chip Roy, R-TX, Michelle Fischbach, R-MN, and Sen. Steve Daines, R-MT, led 89 House Members and eight Senators in the bicameral letter of inquiry, which comes after the New York Times reported on the shockingly high false-positive rates of certain prenatal genetic screenings for rare genetic disorders. The tests give false-positives at a rate of 85%, the Times reported.

Positive results in prenatal screenings, including those countless false positives, can be cited by doctors to encourage parents to consider aborting their children.

“Many of these tests have not been approved by the FDA,” according to a press release from the office of Rep. Chip Roy. “The letter seeks responses from the FDA as to its regulatory authority as well any further action it may take regarding the accuracy of these tests.”

“When I first read the troubling New York Times story on noninvasive prenatal testing, I thought of my godson, who was recommended for abortion following a prenatal screening,” said Roy:

He was born perfectly healthy, and to this day, I am thankful that his parents chose life over fear. Many other folks I know have stories like this. These tests have always raised ethical concerns because they can be used for eugenic purposes, and these recent findings about their efficacy only make the problem worse.

“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 states:

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.

The letter, which can be read in full here, concluded with a series of questions for the FDA:

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?
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?