Trump Administration Says Some Coronavirus Tests Can Bypass F.D.A. Scrutiny


“Suppose you get a Covid test and you actually have the infection and it comes back negative,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group. “You may believe you’re OK and that may leave you in your home, exposing family and friends to the virus when you should quarantine.”

Earlier this year, the F.D.A. noted just that problem. In response to an inquiry, agency spokeswoman Emma Spaulding said in a statement in May that there were problems with some of the laboratory coronavirus tests whose developers had applied for emergency authorization.

“Some of the laboratories didn’t do their validation properly, making it impossible to tell if they had a good test or not,” Ms. Spaulding said. “Others included data that suggested the test did not perform well, likely missing far more positive cases than authorized tests.”

Other laboratories, she added, had manufacturing problems such as contamination. And several made unsupported claims in their labels for home testing.

With the new change, the agency would not find out about these problems. Under the policy, the F.D.A. retains the power to give emergency authorizations to companies that voluntary apply for them. The agency may also attempt to institute new rules for these tests, but would have to go through a cumbersome formal review process first. Such rules are subject to White House approval.

The new policy covers tests developed by laboratories certified under the Clinical Laboratory Improvement Amendments program, which is part of the Centers for Medicare and Medicaid Services. It does not change the requirements for tests that are made and marketed by companies to be sold off site, such as the rapid point-of-care tests for the coronavirus.

Susan Van Meter, executive director of AdvaMedDx, the diagnostic division of AdvaMed, the medical device trade group, said her organization was still trying to assess the implications of the policy. Ms. Van Meter also said her organization would like to see the F.D.A.’s entire policy on lab-developed tests updated.

“We really think a new, overarching, modernized regulatory framework for all diagnostic tests” is important, she said.



Source link

Leave a Reply

Your email address will not be published. Required fields are marked *