The U.S. Department of Health and Human Services (HHS) has ordered the FDA to cease requiring developers of lab-developed tests (LDTs) to go through the agency’s premarket review mechanisms before offering an LDT. The context of the order might at first blush be interpreted as limiting the scope of the order to the public health emergency (PHE) to the COVID-19 pandemic, but the statement expands the temporal scope by referencing a need for rulemaking on the FDA’s part, one of several indications that this order is intended to outlast the PHE.

The FDA’s handing of testing for the pandemic has proven controversial in several respects, including allegations that the agency’s approach is driven more by a reflexive institutional bias toward regulation. The HHS notice said that the Trump administration is committed to addressing both the current pandemic and to ensure that the federal government is able to address future pandemics. The statement further noted that this includes “keeping duplicative regulations and unnecessary policies from interfering with those efforts,” adding that this change in policy is in keeping with two Trump administration executive orders, including the two-for-one Executive Order 13771.

The HHS notice said that the FDA will no longer require premarket review of LDTs absent the notice-and-comment process required for rulemaking, rather than allowing the agency to create active policy via guidance, website statements and other informal mechanisms. This approach seems to fall under the scope of an Aug. 11 statement by the Department of Justice, which questioned whether the Administrative Procedures Act is in need of a statutory overhaul due to what is often perceived as a federal government agency aversion to rulemaking. That announcement and the underlying report will be covered in an upcoming issue of BioWorld.

Non-EUA tests not included in PREP Act immunity

The HHS statement said labs can continue with voluntary submissions to the FDA for their tests for the SARS-CoV-2 virus, although any test that is conducted outside an FDA review would not fall under the scope of the Public Readiness and Emergency Preparedness (PREP) Act. The PREP Act, which confers immunity from prosecution under product liability law, does not apply to instances of willful misconduct, however, and does not obviate a lab’s operational requirements under the Clinical Laboratory Improvement Amendments of 1988.

The Advanced Medical Technology Association (Advamed) – which has long argued for a level regulatory playing field between LDTs and commercially distributed testing kits – said in an Aug. 20 press release that the association supports policies that foster innovation. However, Advamed President and CEO Scott Whitaker said, “we encourage the administration to ensure all test developers … are subject to the same standards of test validation during the pandemic and beyond.” Whitaker reiterated the association’s support for the House Energy and Commerce LDT bill, the Verifying Accurate, Leading-edge IVCT Development (VALID) Act, which has a companion bill in the Senate.

Conversely, the Association for Molecular Pathology (AMP) characterized the change in an Aug. 21 statement as an elimination of duplicative regulatory mandates. AMP’s president, Karen Weck, said FDA premarket programs “delayed the U.S. response in the early days of the coronavirus pandemic.” She stated further that FDA oversight of LDTs “slows innovation and compromises patient access to potentially lifesaving procedures,” adding that AMP supports the Verified Innovative Testing in American Laboratories (VITAL) Act, sponsored by Sen. Rand Paul (R-Ky.). The VITAL Act would largely eviscerate the FDA’s authority to regulate LDTs, but the related entry at congress.gov indicates that the bill has attracted the co-sponsorship of only one other senator.

Harvard’s Mina sees decision as having little impact

The question of the impact of the HHS declaration was taken up by Michael Mina, assistant professor of epidemiology at the T.H. Chan School of Public Health at Harvard University, in an Aug. 21 Zoom briefing. Mina said, “I think there’s been a lot of confusion about who plays what roles in this epidemic” at HHS, although he said the policy switch is “very nuanced” and “will have little bearing” on the ability to use tests to navigate through the pandemic.

“The reason it doesn’t change much is because it only affects CLIA labs,” Mina said, adding that commercial test developers are unaffected while labs “can do once again what they normally do.” He said the PHE announcement invoked the emergency use authorization (EAU) requirement for tests for any viruses in the coronavirus family, not just the SARS-CoV-2 virus. The FDA has, however, been inundated with EUA applications for various types of tests, but even before the EUA series, labs had developed highly accurate tests as early as February 2020 that “we weren’t allowed to use on our patients” because of the FDA approach.

Nonetheless, Mina characterized the move by HHS as “a good decision because frankly, if you’re a CLIA lab director … you feel like you should create the very best test you can. The concern now is that with the FDA [review] removed, there is such demand that I worry that everyone with a medical license might see some money here” and set up a lab, without a sufficient body of experience. “When there’s money on the table … even well-meaning physicians might go awry,” he said.

The policy switch was not received by lab operators as a stunning or wholly unexpected development, Mina said, in part because there was already a widespread perception that the EUA requirement was an unnecessary handcuffing of labs. “It was seen as onerous and unnecessary in the beginning, and this is putting things back to normal,” he said, adding that the news does nothing to further the damage to the FDA’s already-strained reputation among clinical laboratorians.