The race to test and treat the coronavirus is a nationwide effort, with scientists, philanthropists, and governments across the country pouring in financial resources and expertise. But innovators and funders, such as billionaire Microsoft founder Bill Gates, are quickly learning their efforts can come to a screeching halt without proper federal permissions.
On May 15, the New York Times reported that the U.S. Food and Drug Administration ordered a successful public-private COVID-19 testing and surveillance program to cease operations pending agency approval. There wasn’t any concern about the safety or efficacy of the tests, but rather about patients having access to their own results. This sudden FDA directive is just the latest misstep for an agency that has repeatedly dragged its feet in approving COVID-19 testing. Continued inaction and approval delays will only mean a slower reopening process and more misery for a world in wait.
Seattle was the coronavirus’s first foothold in the United States, but the Emerald City was also home to one of the first comprehensive efforts to track and trace the deadly disease. As a result of a partnership between Gates and Seattle and King County public health officials, both healthy and sick patients across Seattle have been receiving self-swab test kits at home since March.
These kits, which were approved by the Washington State Department of Health, were promptly analyzed by researchers. They allowed public health officials to keep tabs on where, and how quickly, the coronavirus was spreading. Since the start of testing, this “Seattle Coronavirus Assessment Network” kept in close communication with FDA officials and submitted its data to the agency. But all the communication and data-sharing in the world couldn’t keep the famously risk-averse FDA from shutting down the program in mid-May barring further approvals.
In a statement, SCAN noted, “The FDA has not raised any concerns regarding the safety and accuracy of SCAN’s test, but we have been asked to pause testing until we receive that additional authorization.” The agency isn’t concerned with the integrity of the data, but rather about disclosure of the results. Bizarrely, the FDA is concerned that researchers are informing their patients about test results after analyzing swab samples.
To most observers, this sharing of information is a positive development and helps test-takers be more vigilant in their day-to-day activities. FDA bureaucrats, however, are concerned that giving this information to patients makes the SCAN project a diagnostic service (i.e., offering patients diagnoses) rather than a surveillance endeavor.
Under the agency’s strange logic, it’s OK for public health authorities to test for the coronavirus, but not OK to give patients access to their own results. An FDA spokesperson told the New York Times, “We had previously understood that SCAN was being conducted as a surveillance study,” implying that supplying test takers with the end results isn’t allowed.
But as Scripps Research Translational Institute (not involved with SCAN) director Dr. Eric Topol points out, “To withhold that information from people is downright absurd.”
Nor is this the FDA’s first misstep related to coronavirus testing. In February, the agency refused to allow research laboratories to develop their own alternatives to the Centers for Disease Control and Prevention’s faulty COVID-19 test. Many laboratories have since gotten FDA approval to develop their own tests, but these facilities must comply with two sets of regulations from two separate governmental bodies. Laboratories have traditionally been governed by the Centers for Medicare and Medicaid Services, but are now also beholden to the FDA for testing approval.
Fortunately, Republican Kentucky Sen. Rand Paul is proposing S. 3512, the VITAL Act, which would keep private laboratory coronavirus testing outside of the FDA’s purview. But even absent a congressional solution, the FDA must give scientists and philanthropist backers such as Gates the benefit of the doubt in scaling up COVID-19 testing solutions for patients. The private and public sectors are willing to work together to contain the coronavirus, bureaucrats permitting.
Ross Marchand is the director of policy for the Taxpayers Protection Alliance.
