HHS Clears the Way for Use of New COVID-19 Tests without FDA Emergency Use Authorization

One of the unforeseen results of the coronavirus public health emergency has been to bring the perennial controversy over U.S. Food and Drug Administration (FDA) premarket regulation of laboratory developed tests (LDTs) to a head. As the crisis has deepened, the agency has found itself in the position of backing away from its hands-on approach and has allowed laboratories and test makers greater discretion in launching LDTs detecting the SARS-CoV-2 virus. And now a new Administration pronouncement carries that policy to a new and significant level.

The Controversy Over FDA LDTs Regulation

Laboratory tests were not included in the original legislation that created the FDA and current regulatory system of medical drug and device regulation. So, the agency has relied on its powers to regulate devices. Accordingly, LDTs must obtain premarket approval through the 510(k) pathway for medical devices.

 In addition to challenging the FDA’s authority over LDTs, the laboratory industry has long objected to the agency’s practice of skirting the regulatory process and relying on guidance, website statements and other informal issuances to make regulatory policy.

 The HHS Decision

And now the U.S. Department of Health and Human Services (HHS) has taken the same position. On August 19, HHS announced that the FDA will no longer be able to regulate by informal decrees but will have to go through the customary notice and comment rulemaking process required for new regulations to regulate LDTs.

One result of the HHS decision, which is part of the Administration’s broader policy to cut government regulation over business, is that laboratories will now be able to offer LDTs for SARS-CoV-2 without going through the FDA’s Emergency Use Authorization (EUA) process. “Those with an active EUA to use an LDT to detect the virus causing COVID-19 or its antibodies are unaffected by this announcement,” HHS added.

And Don’t Forget the VALID Act

The unexpected HHS announcement is the most recent in a series of efforts to rein in FDA regulation over LDTs. After several aborted attempts, last March, legislators in the U.S. House of Representatives and Senate reintroduced the Verifying Accurate Leading-edge IVCT Development Act (VALID) creating a new system for FDA review of in vitro clinical tests (IVCTs). VALID would establish a risk-based framework, with high-risk tests, like novel assays, required to go through premarket review; lower-risk tests could go to market after passing through technological certification. Specific features that VALID would implement:

• Establishment of a technology certification program for lower-risk tests;
• Requirement that high-risk tests undergo premarket review to verify analytical and clinical validity;
• Authority of the FDA to require that any test undergo premarket review after providing the developer an opportunity to address issues identified by the agency; and
• Creation of a new system to allow hospitals and laboratories to submit their tests electronically to the FDA for approval.

The law would also grandfather in existing LDTs being used clinically.

Takeaway

The pandemic has exposed the problems with the FDA’s current makeshift premarket control over LDTs and how it stifles innovation and keeps desperately needed new tests from reaching the market. It has also accelerated the efforts to impose a modern, more transparent and workable system not only for the rest of the pandemic but the long-term future.