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Trump administration bars FDA from regulating some laboratory tests, including for coronavirus
Source: Washington Post
Trump administration bars FDA from regulating some laboratory tests, including for coronavirus
Some public health experts worry defective tests could end up on the market, but others cheer the change, saying it is long overdue
By Laurie McGinley and Yasmeen Abutaleb
8/20/2020, 8:05:13 p.m.
The Trump administration this week blocked the Food and Drug Administration from regulating a broad swath of laboratory tests, including for the coronavirus, in a move strongly opposed by the agency.
The new policy stunned many health experts and laboratories because of its timing, several months into a pandemic. Some public health experts warned the shift could result in unreliable coronavirus tests on the market, potentially worsening the testing crisis that has dogged the United States if more people get erroneous results. They argued the change is unlikely to solve current testing problems, which at this point are largely due to shortages of supplies such as swabs and chemical reagents.
But supporters cheered the change as long overdue, saying it could help get new and more 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 ensure such bottlenecks don’t recur.
Administration officials said the decision, announced Wednesday on the website of the Department of Health and Human Services, was made for legal reasons. They said the FDA lacks the authority to regulate laboratory-developed tests — a significant part of the market. The agency, they said, can only obtain that through a formal rulemaking process or legislation; those options are unlikely to occur any time soon. The officials spoke on the condition of anonymity to freely discuss the decision.
The change in policy came as a surprise to many at the FDA and was a point of intense disagreement between HHS Secretary Alex Azar and FDA Commissioner Stephen Hahn. Tensions have been rising between the two men for weeks, according to several people familiar with the situation who spoke on the condition of anonymity because they did not have clearance to talk about it. Hahn vociferously opposed the change, arguing the agency has the authority to regulate laboratory-developed tests during a public health emergency like the current pandemic, the individuals said.
-snip-
Some public health experts worry defective tests could end up on the market, but others cheer the change, saying it is long overdue
By Laurie McGinley and Yasmeen Abutaleb
8/20/2020, 8:05:13 p.m.
The Trump administration this week blocked the Food and Drug Administration from regulating a broad swath of laboratory tests, including for the coronavirus, in a move strongly opposed by the agency.
The new policy stunned many health experts and laboratories because of its timing, several months into a pandemic. Some public health experts warned the shift could result in unreliable coronavirus tests on the market, potentially worsening the testing crisis that has dogged the United States if more people get erroneous results. They argued the change is unlikely to solve current testing problems, which at this point are largely due to shortages of supplies such as swabs and chemical reagents.
But supporters cheered the change as long overdue, saying it could help get new and more 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 ensure such bottlenecks don’t recur.
Administration officials said the decision, announced Wednesday on the website of the Department of Health and Human Services, was made for legal reasons. They said the FDA lacks the authority to regulate laboratory-developed tests — a significant part of the market. The agency, they said, can only obtain that through a formal rulemaking process or legislation; those options are unlikely to occur any time soon. The officials spoke on the condition of anonymity to freely discuss the decision.
The change in policy came as a surprise to many at the FDA and was a point of intense disagreement between HHS Secretary Alex Azar and FDA Commissioner Stephen Hahn. Tensions have been rising between the two men for weeks, according to several people familiar with the situation who spoke on the condition of anonymity because they did not have clearance to talk about it. Hahn vociferously opposed the change, arguing the agency has the authority to regulate laboratory-developed tests during a public health emergency like the current pandemic, the individuals said.
-snip-
Read more: https://www.washingtonpost.com/health/2020/08/20/trump-fda-tests-coronavirus/
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