Changes to FDA’s review of lab-developed tests may allow these tests greater protection from liability
Since the early days of the COVID-19 pandemic, laboratory developed tests (LDTs) have played an important role. These tests allow for some CLIA-certified laboratories to develop and validate their own tests for COVID-19 and allowed certain laboratories to help accommodate the increased need for COVID-19 testing, especially in the earlier days of the public health emergency.
The regulation of LDTs continues to be an area of debate, and recent events during the pandemic have led to changes and potential confusion. In late August 2020, the US Department of Health and Human Services (HHS) provided guidance indicating that the US Food and Drug Administration (FDA) did not have the authority to regulate LDTs.
HHS issued the statement as part of its, “review of regulatory flexibilities enacted since the start of COVID-19.”
While the FDA recognized this decision, the agency continued to encourage clinical laboratories to voluntarily submit emergency use authorizations (EUAs) for FDA review. HHS said in a statement at the time, “Those seeking approval or clearance of, or an emergency use authorization (“EUA”) for an LDT may nonetheless voluntarily submit a premarket approval application, premarket notification or an EUA request, respectively, but are not required to do so, and FDA will adjudicate those submissions.”
Increased Liability Risk in the Absence of FDA LDT Review
At the time, the HHS provided specific consideration for clinical laboratories that were considering using or developing LDTs. “Those opting to use LDTs in their laboratories without FDA premarket review or authorization may do so with the understanding that they would not be eligible for Public Readiness and Emergency Preparedness (PREP Act coverage absent approval, clearance or authorization,” HHS announced, further noting that these laboratories “would remain subject to regulation by the Centers for Medicare and Medicaid Services under the Clinical Laboratory Improvement Amendments of 1988, and its implementing regulations.”
So while labs may have welcomed the loosening of the FDA’s LDT regulations, the change came with an increased risk of liability. Any lab choosing to use an LDT without FDA premarket review or authorization would not be eligible for immunity protection under the PREP Act, unless the lab gets approval, clearance, or authorization from the FDA, HHS’ statement said.
FDA Explains LDT Review Priorities, HHS Adds New Twist
In a sudden shift, however, the FDA announced in October 2020 that it would no longer review EUAs that were voluntarily submitted for LDTs. The FDA said that the decision was made to “prioritize review of EUA requests for POC tests, home collection tests, at-home tests, tests that reduce reliance on test supplies, and high-throughput, widely distributed tests,” according to a statement by the agency.
With the FDA’s October announcement, it appeared the agency would focus its reviews of EUA requests toward COVID-19 tests that present the least resistance in processing to test result and accessibility for the masses.
However, in yet another swerve, HHS asserted authority and reversed the FDA’s recent decision. In mid-November, Adm. Brett Giroir, MD, Assistant Secretary for Health at HHS, announced that the FDA will resume reviewing EUAs that are voluntarily submitted for LDTs. Giroir also announced that these EUA applications will be reviewed rapidly, and announced a provision for the National Cancer Institute (NCI) to provide the FDA with help if the FDA’s review process takes longer than 14 days.
EUA submissions for LDTs continue to be voluntary, but according to Giroir, “Without an EUA, although the test can be used, it cannot receive liability protection by the PREP Act.” The PREP Act provides immunity “from suit and liability under federal and state law” if an LDT receives FDA premarket review or authorization. The potential lack of protection under the PREP Act seems to be one of the main motivators in HHS’ recent decision to resume EUA reviews for LDTs and to expedite these reviews.
Skepticism New LDT Review Process Will Work Smoothly
One confusing factor in this recent announcement has been the inclusion of the NCI in the review process. It is “hard to imagine that FDA will be able to complete its EUA review of the backlog of LDT tests within 14 days” or that the FDA is “in favor of NCI stepping in to regulate in the LDT space,” Kyle Faget, an attorney at law firm Foley and Lardner, said in a recent interview. The NCI is part of the National Institutes of Health (NIH), and it seems likely that there will be some difficulty in coordinating the review of the backlog of EUAs through two separate agencies.
This is an important development with major implications for any clinical laboratory that performs LDTs. The multi-year effort by the FDA to claim its authority to regulate LDTs by issuing guidance documents has been regularly disputed by many lab companies, national laboratories, and trade groups.
Clinical laboratories that have developed—or are in the process of developing—an LDT may benefit from this recent change, as they may be able to gain protection under the PREP Act. It is unclear how straightforward the process will be, however, when submitting an EUA that may be reviewed by the NCI in addition to the FDA. Clinical labs that are developing LDTs should also understand that with this recent change, they are still not obligated to apply for an EUA.
—By Caleb Williams, Editor, COVID-19 STAT