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FDA Dramatically Expands Enforcement Discretion to Speed COVID-19 Test Access

NEW YORK – The US Food and Drug Administration has dramatically expanded its enforcement discretion over local labs and test kit manufacturers allowing them to deploy SARS-CoV-2 testing with limited federal oversight.    

In a guidance released Monday evening, the agency discussed two pathways for test developers to offer patients testing. Labs using the first pathway can validate their tests, notify the FDA, and file for Emergency Use Authorization with the FDA within 15 days. This is what the FDA described in a Feb. 29 guidance. A number of hospital and academic labs have utilized this strategy, including the University of Washington and NorthShore University HealthSystem. 

Now the agency is extending this same policy for commercial manufacturers, such as Roche and Hologic (both of which have received EUAs for coronavirus test kits), allowing them to validate their test kits and rapidly distribute them around the country. The manufactures must notify the FDA and submit an EUA within 15 days.  

Under the second pathway, states must take the responsibility for ensuring the accuracy of tests developed and launched by local labs. This is an extension of the action the FDA took on March 12, in exercising "enforcement discretion" and allowing New York State Department of Health to authorize certain labs to provide testing. 

The agency said it took this action in response to a request from the NYSDOH's Wadsworth Center, asking if it could authorize entities that held a state clinical lab permit to notify the center when they had validated a SARS-CoV-2 test and subsequently submit validation studies directly to the center. According to the FDA, the Wadsworth Center volunteered to take responsibility for notifying the labs of any concerns with the tests' performance characteristics, asking them to issue corrected reports, and requiring them stop testing if there are further issues. Under non-emergency circumstances, NYSDOH has one of the most robust clinical testing review and approval programs in the country. 

On March 13, President Donald Trump issued a "Memorandum on Expanding State-Approved Diagnostic Tests," which allowed the Department of Health and Human Services to promulgate policies that allow other states to similarly authorize testing for COVID-19. Under this policy, because the states have oversight responsibility, "notification of SARS-CoV-2 test validation is not submitted to FDA and the laboratory does not submit an EUA request to FDA," the agency said, adding that the states or territories must notify the agency if they decide to choose this pathway for enabling test access.

The FDA said it will not review the authorization process adopted by a state, which may be different to the NYSDOH's policies. However, the agency did request that labs provide it information on testing capacity, which will "help [the government] monitor the landscape as we work to ensure adequate testing capacity across the country."

Lastly, the FDA said it wouldn't object if commercial manufacturers began selling and labs began conducting serology tests to identify antibodies to SARS-CoV-2 when such testing is performed in a lab or by healthcare workers at the point of care. The agency said in the guidance that since such tests are less complex than molecular diagnostics, it would not object to labs and manufacturers offering such testing as long as the agency is notified and test reports inform patients that the test hasn't been reviewed by the FDA and has certain limitations. 

These actions come as the FDA is being heavily criticized for not exercising enforcement discretion in the early days of the public health crisis, thus potentially hindering the ability of labs to develop tests in house and make them available to patients. The agency has defended that it has been flexible and has been working closely with labs to ease the path for launching tests. At the same time, the agency has continue to impress upon stakeholders that it is important, especially during a public health emergency, to ensure that tests are accurate and not harming patients.

"In the context of a public health emergency involving pandemic infectious disease, it is critically important that tests are validated as false results can have broad public health impact beyond that to the individual patient," the agency reminded in the latest guidance. 

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