What a Biden Administration Might Portend for Regulation of Laboratory Developed Tests

The roller coaster that has become FDA regulation of laboratory developed tests (LDTs) is about to get even more topsy-turvy now that Joseph Biden has been elected President of the United States. Here’s a look at where things stand and what we might expect from the Biden administration. FDA Review of LDTs One of the new administration’s first orders of business will be to ensure a robust pipeline of COVID-19 molecular, antibody and antigen tests. To accomplish that objective, the Biden FDA will likely consider the reversing the controversial LDT policy changes recently announced by the Trump administration. In August, HHS announced that the FDA would no longer require premarket review for LDTs but that labs could still voluntarily seek approval, clearance or emergency use authorization (EUA). But in October, the FDA pulled the rug out by announcing that it would no longer perform EUA review of COVID-19 LDTs so that it could concentrate its resources on “innovative” new tests in the interests of public health. The announcement came as a stunner, particularly since many of the most innovative new COVID-19 tests were LDTs from companies like Abbott and LabCorp. And it’s not just COVID-19. The policy shift reversing the FDA’s long-established approach applies to all LDTs, including badly needed cancer tests. So, it would not be shocking at all if the Biden administration reverses these policy changes and restores the pre-August status quo. Legislative Reform A divided Congress and semi-toxic partisan political environment will make it very difficult to enact new healthcare legislation. However, President-elect Biden was Vice President for an administration that did make an active attempt to modernize and reform the LDT regulatory system. Although the lab industry was far from enamored of them, the proposals put forward by the Obama FDA advanced the debate and provided impetus to legislative reform. In early March, legislators in the House and Senate introduced a bill for regulating in vitro clinical tests (IVCT) called the Verifying Accurate Leading-edge IVCT Development Act (VALID) that would create a new product category for diagnostic and lab tests, putting their review and approval under the FDA. It would also overhaul how the FDA reviews and approves diagnostic tests while giving labs greater flexibility in responding to public health emergencies. Essentially, VALID creates a risk-based framework for IVCT regulation, 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. Key provisions:

• 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 labs to submit their tests electronically to the FDA for approval, a move that would speed up the approval process and increase the quality and reliability of the testing, according to the bill summary.

Prospects for Change The fact that VALID has bi-partisan support makes it a viable framework for legislative reform of LDTs regulation, if the will to enact such legislation it exists. But at least from a lab industry perspective, it needs a lot of fine tuning. In its initial response to VALID, the American Clinical Laboratory Association expressed support for reform legislation and outlined three principle priorities:

• Reform that recognizes diagnostics as separate and distinct services from medical devices, and that also distinguishes between LDTs and in vitro devices;
• Grandfather and transition policies that protect patient access to currently available lab tests; and
• A regulatory system that balances the needs of innovation and appropriate regulatory oversight to ensure the accuracy, reliability and access of these tests.

Takeaway The inauguration of a new president is generally a cause for optimism and an opportunity to bring new energy to tackle old healthcare challenges, especially during times of pandemic. And while LDTs aren’t on the top of its agenda, they will no doubt command significant attention during the early days of the Biden administration. The most immediate action could be the rollback of the recent FDA premarket regulatory policy changes. The long-term efforts to reform the system are also likely to continue, both on the regulatory and legislative fronts.