By Robin Foster and E.J. Mundell
FRIDAY, Aug. 21, 2020 (HealthDay News) — The Trump administration has blocked the U.S. Food and Drug Administration from regulating a wide swath of laboratory tests, including ones for the coronavirus.
The new policy, which was posted Wednesday and is strongly opposed by the FDA itself, stunned health experts and laboratories because of its timing, the Washington Post reported.
The change could result in unreliable coronavirus tests getting on the market, potentially worsening the testing crisis in the United States, experts told the newspaper. The one thing the change won’t do is solve testing shortages, because those are due mostly to a lack of the swabs and chemical reagents needed to perform COVID-19 tests, the Post reported.
However, supporters claimed it could help get innovative tests to market more quickly. They said that the FDA review process sharply slowed testing at the beginning of the pandemic, and that the new policy could guard against future bottlenecks, the Post reported.
Administration officials told the Post that the decision was made for legal reasons. But FDA Commissioner Stephen Hahn staunchly opposed the change, arguing that such authority is critical during a public health emergency like the pandemic, the newspaper reported.
The tests affected by the change are those developed by and used at laboratories regulated under the federal government’s Clinical Laboratory Improvement Amendments program, the newspaper said. Such labs are in big academic medical centers, smaller commercial laboratories and big testing companies such as Quest and LabCorp, the Post reported.
The history of the FDA’s power to regulate lab-developed tests has long been murky. For years, the FDA has asserted authority over the tests but has typically only acted on it in the midst of health crises, the Post reported.
During the Obama administration, the FDA proposed tighter regulation during normal times, a move that drew intense opposition from labs and never happened. But during public health emergencies, the FDA has required test developers to seek an emergency use authorization that allows regulators to review the tests for accuracy, the newspaper said.