In response to a dire shortage of tests for detecting the fast-moving coronavirus, the Food and Drug Administration is giving states new powers to authorize laboratories to develop their own diagnostic. And the FDA also approved new tests that will be distributed by LabCorp (LH) and Hologic (HOLX), two of the largest manufacturers.
The agency will allow states to take responsibility for tests developed and used by laboratories within their borders, a step that is similar to what the FDA last week granted to the New York State Department of Health. The labs will not have to pursue Emergency Use Authorization from the agency, an emergency clearance that is normally required.
The FDA also announced two other moves. Under certain circumstances, the agency will not object to any manufacturers that distribute newly developed tests before the FDA grants emergency clearance, and a similar stance will be taken toward labs that use these new tests. Finally, the agency is issuing new recommendations for companies that want to develop blood tests for measuring antibodies.
“The policy is intended to achieve a balance between providing regulatory flexibility while allowing for scientific rigor,” Commissioner Stephen Hahn told the media during a briefing Monday night. “… We believe this will [create] a surge to meet the demand we expect to see, although it is somewhat difficult to quantify” the number of tests that will become available.
The moves come as the Trump administration has been heavily criticized for failing to anticipate the advent of the novel coronavirus, known as Covid-19, earlier this year and for not putting in place the testing needed to detect its spread around the U.S. Ever since, the White House has been on the defensive, scrambling to find ways to compensate by getting much-needed tests to public health officials.
Currently, the U.S. has capacity to run just 175,000 tests a week, according to an effort to track that capacity run by former FDA Commissioner Scott Gottlieb at the American Enterprise Institute. Even if those additional tests come online all at once, patients may not be able to get them. The FDA attempted to close the gap last week by approving tests by Roche Diagnostics and Thermo Fisher.
So far, more than 4,000 cases of Covid-19 have been confirmed in the U.S., according to a tally by the Johns Hopkins University Center for Systems Science and Engineering. Accurate testing is critical to stopping the outbreak and the states have been clamoring for additional tests.
Administration officials described the moves as a necessary trade-off, despite any risks. For instance, the FDA acknowledged there may be snafus — such as problems with validation data — with tests that are allowed on the market before obtaining emergency clearance. The agency would work with manufacturers to rectify any deficiencies and, if need be, recall the test.