Despite the failure of Congress to pass legislation on laboratory developed tests (LDTs), the U.S. Food and Drug Administration (FDA) is not waiting for new powers and is moving forward with rulemaking on LDTs. Speaking at an industry conference, FDA Associate Director Elizabeth Hillebrenner stated that the agency cannot “just stand by” given the perceived public health problem created by LDTs. The FDA has yet to set a timeline for LDT rulemaking or provide a close look at its plans, but Hillebrenner noted that the agency will follow a three-tier risk framework.
The Verifying Accurate Leading-Edge IVCT Development (VALID) Act, introduced to Congress in 2018, would clarify the FDA’s authority to regulate LDTs and give the agency new powers. Although key aspects of the draft advanced as part of the FDA’s user fee package last year, they were ultimately cut from the final version. A push to pass the VALID Act as a standalone law fell short late last year. Despite this, the FDA continues to support legislation that provides a regulatory framework for LDTs in line with modern diagnostics. However, in the ongoing absence of action from Congress, the FDA is now advancing work on LDTs under its current statutory authority.
