OMB Completes its Review of the Final LDT Rule—A Final Rule Coming Anytime Now

April 25, 2024By Allyson B. Mullen & Jeffrey N. Gibbs

We’ve been hearing for quite some time that a Final LDT Rule would likely be coming this spring, before May 1.  This timing has been attributed to FDA’s desire to avoid having the rule being overturned by Congress under the Congressional Review Act.  Of course, if a new administration takes over next year, the rule’s future would be questionable, even without congressional action.

As of Monday, April 22, FDA appears to be one step closer to achieving that timing goal with Office of Management and Budget (OMB) having completed its review of the final rule (see here). Our readers will recall that the rule went to OMB on March 1 for its review. OMB completed its review by concluding the final rule is “Consistent with Change.”  This conclusion means that OMB has returned the final rule to FDA with changes.  There is no way to know from this coding the source or extent of the changes as even editorial changes can cause a rule to be coded “Consistent with Change.”  Regardless of the changes, however, OMB has concluded that the final rule is consistent with its mandate to review final rules.  Bottom line – OMB did not object and FDA just cleared one more hurdle on its way to issuing the final rule.

The final rule was identified by OMB as Section 3(f)(1) significant meaning that the rule “may have an annual effect on the economy of $200 million or more . . . ; or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, territorial, or tribal governments or communities.”  (see here) With much at stake, OMB has held over two dozen meetings regarding the proposed rule (see here) with approximately half of those occurring since the final rule went to OMB for review.  The meetings have presented a mix of views with some organizations meeting with OMB being in favor of FDA regulation and others being very much opposed.

With a final rule now nearly a certainty, a legal challenge seems likely to follow.  As we have previously noted, there are plenty of grounds for challenging any final rule that is released (see our prior post here).

We will, of course, keep our readers up to date on the final rule.