HHS to FDA: Resume EUA Review of COVID-19 LDTs, And Do It Fast

The controversy over FDA Emergency Use Authorization (EUA) of laboratory developed tests (LDTs) for COVID-19 is on high boil once more. A month after the agency announced it would no longer review such tests, the Department of Health and Human Services (HHS) has countermanded that decision, ordering the FDA to resume LDT EUA applications and do it in a “timely manner.” The new HHS mandate is the latest and perhaps most decisive twist in what has become a somewhat bizarre battle within the administration over regulation of LDTs that has sparked up during the public health emergency.   The Controversy Over COVID-19 LDTs Some of the earliest, most innovative and important new COVID-19 tests to receive EUA in the early days of the pandemic were LDTs created by testing companies, universities and medical centers, including molecular and antibody assays, as well as saliva and home-collection products. The demonstrated ability of labs to step up and meet the unprecedented demand for new COVID-19 tests seemed to vindicate the decades-old case for relaxing FDA regulation in the interest of innovation and public health. The other impetus to rapid change was the current administration’s general policy of cutting regulatory red tape for business. Historically protective of its regulatory authority over LDTs, the FDA needed a little prodding to loosen the reins. That prodding came on Aug.19 when the HHS announced that the FDA would no longer require premarket review for LDTs but that labs could still seek EUA voluntarily. In addition, the FDA would now have to use the notice and rulemaking process to create new rules and could no longer regulate LDTs via website notices and other informal methods. On Oct. 7, the FDA fired back by announcing that it was bowing out of EUA review for any LDTs to “make the best use” of its review resources and prioritize “innovative, high-throughput [tests] that have reduced reliance on supplies and been integral to expanding testing capacity.” It was a head scratching decision to the extent that the COVID-19 tests that passed through the EUA pipeline were precisely the types of products the FDA’s new policy purported to promote. The decision, which applied not just to new submissions but also to LDT EUA applications already in the pipeline, threatened to chill LDT development by stripping labs of crucial liability protections. While supportive of the initial HHS policy, the lab industry criticized the FDA decision and called on the agency to continue to let labs continue to voluntarily seek EUA for COVID-19 LDTs. HHS Orders FDA to Resume EUA Review The most recent twist came on Nov. 16 when HHS Assistant Secretary for Health and White House coronavirus testing czar Brett Giroir ordered the FDA to resume EUA review of COVID-19 LDTs, and do it fast. The agency’s orders are to clear the backlog of submissions created by its decision to cease review within 14 days. If, as is highly likely to prove the case, the FDA can’t meet that deadline, the National Cancer Institute (NCI) will step in to help. “We recognize the FDA has a huge workload,” Giroir noted. “That’s why we’re trying to provide additional resources. I don't think anybody can question the scientific integrity of the NCI.” What’s At Stake The reason the HHS has chosen to intervene is the fear that labs won’t create new LDTs for COVID-19 unless they can secure EUA because of potential liability exposure if the product doesn’t work as planned. Explanation: Normally, new diagnostics and medical products must undergo long and extensive clinical review before they can reach the market. But in times of public health emergency, it becomes necessary to accelerate the standard review protocols. The upside of abbreviated vetting is that products become available faster; the downside is that they carry greater than normal risks to users. Accordingly, producers are at higher risk of being sued for products liability. To ensure that fear of liability doesn’t chill innovation, a federal law called the Public Readiness and Emergency Preparedness Act (PREP) provides immunity to test makers and other producers that create medical products in response to a public health emergency. The FDA decision not to perform EUA review of LDTs for COVID-19 effectively strips test makers of their PREP immunity and makes them a sitting duck for trial lawyers and products liability lawsuits. Giroir acknowledged that this was behind the order for FDA to resume EUA review of COVID-19 LDTs, noting on a media call that “without an EUA, although the tests can be used, they cannot receive liability protection under the PREP Act.” Giroir added that the goal is to ensure that universities and other LDT makers are “given the same liability protection as major corporate developers and manufacturers.” Takeaway Although not cited by HHS, there’s another factor that makes the new policy so important and beneficial to makers of COVID-19 LDTs, namely, reimbursement. The Families First Coronavirus Response Act (FFCRA) requires commercial payors to cover medically necessary SARS-CoV-2 testing without cost sharing, but only if those tests have EUA from the FDA. Consequently, labs developing new SARS-CoV-2 LDTs without securing EUA status face the prospect of not being reimbursed for their tests.