The Centers for Disease Control and Prevention developed the first COVID-19 diagnostic test in January 2020. The Government Accountability Office (GAO) says this test was flawed, which contributed to the delayed rollout of testing nationwide.
GAO’s May 12 report says the Food and Drug Administration (FDA) took several actions aimed at increasing the availability of COVID-19 tests in the United States. These actions included granting emergency use authorizations (EUA) for more than 400 COVID-19 tests and sample collection devices by the end of 2021.
GAO also found that FDA exercised enforcement discretion for certain COVID-19 tests —that is, it did not object to laboratories’ use of these COVID-19 tests before FDA had authorized them; this did not apply to tests that could be used at home. GAO determined that FDA’s use of enforcement discretion helped increase test availability early in the pandemic.
As of September 30, 2021, FDA had exercised its enforcement discretion for 370 tests. Test developers had submitted EUA requests for these tests, but FDA had not yet reviewed them. FDA officials told GAO they had concerns about the lack of review for these unauthorized tests, and as the number grew, the risks of this policy began to outweigh the benefits. Nevertheless, GAO found that it was not until November 2021 that FDA updated its COVID-19 test policy with the intention of phasing out the agency’s use of enforcement discretion and reducing the number of unauthorized tests.
The government watchdog underlines that FDA has no policy for when it would begin and end exercising enforcement discretion for the use of unauthorized tests in a future public health emergency. Without such a policy, GAO says the agency could face the risk that tests with uncertain accuracy and reliability could be available for use for an extended period of time, even when a sufficient number of authorized tests are available. This could hamper an effective response and recovery during a crisis.
FDA monitors the performance of all COVID-19 tests—whether granted an EUA or not—through reports of performance problems submitted to FDA by test developers, health care providers, and consumers. According to FDA, this includes reports of false positive or false negative test results. By December 31, 2021, FDA had received more than 18,000 such reports for COVID-19 tests and took action to address identified problems. For example, FDA issued 10 letters to clinical laboratory staff and health care providers to inform them of safety concerns about COVID-19 tests.
GAO is calling for FDA to develop a policy for the use of enforcement discretion regarding unauthorized tests in future public health emergencies. It adds that this policy should include the conditions under which FDA would begin and end the use of such discretion. The U.S. Department of Health and Human Services agrees but has pointed out that FDA did not permit the use of these tests, Rather, it exercised its enforcement discretion to not object to the use of certain tests even though they had not yet obtained pre-market approval or EUA.
Lessons have invariably been learned from the pandemic. For example, FDA has learned that it is more effective for public health to authorize a small number of high-capacity tests rather than diffuse resources for the authorization of many lower capacity tests.