WASHINGTON — The Food and Drug Administration is asking Congress for more power to regulate prenatal tests that help identify genetic issues during pregnancy.
The agency’s request came in response to a letter from nearly 100 Republican lawmakers who probed how the FDA was regulating these tests after a New York Times investigation found the five most common prenatal tests frequently provided inaccurate results.
In a new letter to lawmakers obtained by STAT, the FDA admits that it has only limited powers to regulate such products — so limited that for the most part, it doesn’t review them at all. The agency goes on to urge Congress to pass legislation giving the agency greater oversight powers in the sphere.
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