FDA staunchly opposes the change, arguing that such authority is critical during a public health emergency
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 COVID-19.
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 COVID-19 tests getting on the market, potentially worsening the testing crisis in the United States, experts told the newspaper. The one thing the change will not 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. 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 Stephen Hahn, M.D., the head of the FDA, 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.
Washington Post Article