House and Senate Members Introduce Long-Shot Resolutions to Repeal FDA’s LDT Final Rule

May 24, 2024By Steven J. Gonzalez

On May 15th and 16th, respectively, Senator Rand Paul and Congressmen Brad Finstad and Dan Crenshaw introduced Senate and House resolutions “providing for congressional disapproval under chapter 8 of title 5, United States Code” of FDA’s Final Rule to regulate Laboratory Developed Tests (LDTs). These resolutions are the first step in the (unlikely) process to repeal FDA’s Final Rule using the Congressional Review Act (CRA).

Under the CRA, regulations can be repealed by Congress with a simple majority within 60 legislative days of a rule’s submission to Congress for review. However, the President must sign the resolution, if passed, or else it must pass over the President’s veto by a two-third’s majority.

A rule subject to an enacted joint resolution of disapproval does not take effect (or continue to take effect) and also “may not be reissued in substantially the same form, and a new rule that is substantially the same … may not be issued, unless the reissued or new rule is specifically authorized by a law enacted after the date of the joint resolution.” 5 U.S.C. 801(b)(2).

Because the Democratic Party currently holds a majority in the Senate and President Biden would almost certainly veto the joint resolution if it passed, it is highly unlikely these resolutions will garner enough support to be enacted.

Even if the upcoming elections result in a change in Presidential Administration or composition of the Senate, FDA’s Final Rule would be ineligible for review under the CRA, as the 60 legislative days will have elapsed by January 2025. As many observers have noted, this is probably one of the key reasons the FDA rushed to issue the Final Rule as quickly as it did.

Thus, if the current Congress wants to take legislative action to repeal FDA’s Final Rule, it will likely need offer substantive legislation as a substitute for the regulation (e.g., the VALID Act, which has continued support from some members of Congress; or efforts to modernize CLIA)

In the meantime, the rule could be subject to litigation. A new Presidential Administration could also seek to rescind the rule using notice-and-comment rulemaking, which would need to survive potential legal challenges under the Administrative Procedure Act. FDA is relying heavily on the withdrawal of enforcement discretion to implement the rule.  A new administration could therefore basically decide that it will instead simply decide to exercise enforcement discretion, which would effectively put the regulatory requirements on hold.

The Final Rule is on track to go into effect 60 days from its May 6, 2024 publication date and the first phase-out stage is scheduled to take effect on May 6, 2025.  The lab industry should be watching closely for litigation and legislative developments.  If the current version of the Final Rule remains intact, they will need to develop a plan for implementing the first set of requirements in the coming months.