The Trump administration has made the decision to allow coronavirus tests developed by individual laboratories to be used without FDA review.
On Wednesday, the Department of Health and Human Services outlined the decision in a notice, which public health experts warn could lead to malfunctioned tests.
According to two senior administration officials, the new HHS policy is not meant to relax regulations regarding coronavirus testing. Instead, it is based on HHS’s determination that FDA doesn’t have authority over lab-developed tests for any condition, including Covid-19.
“A review by the Office of the General Counsel found that the FDA’s assertion is on uniform procedural and regulatory grounds,” one of the officials said to POLITICO. “They did not gain the authority to regulate LDTs by having gone through a notice and comment rulemaking period, which would be required for an assertion of authority like that.”
For many years, most LDTs (laboratory-developed tests) were available on a limited basis; therefore, the FDA did not require them to undergo review. Now that the tests are much more common and being used to diagnose serious or life-threatening diseases or conditions, the agency is looking to take stronger regulatory precautions.
According to the FDA website, the agency is still advising that during an emerging infectious disease outbreak, the tests “should not be used for clinical diagnoses without FDA’s approval, clearance, or authorization.”
The United States uses mostly device manufactured coronavirus tests, which must obtain FDA permission to market their products. However, lab-developed tests from companies such as LabCorp, are also widely used.
This is just the latest eyebrow-raising move from the Trump administration during the coronavirus pandemic, which has created tension between the HHS and FDA for several weeks, according to sources close to the situation.
“The tests likely to come to market under this policy are many of the ones that aren’t reliable and couldn’t get emergency use authorizations,” a former HHS senior official told POLITICO. “FDA was taking a light touch, to begin with, and the secretary’s office walked away from even a basic public health obligation that they owe doctors and patients.”
