The uncertainty in the future of LDTs cannot be overstated; there are any number of things that can happen over the course of the next months and years, leaving laboratories in a very uncertain environment. The lawsuits against FDA by American Clinical Laboratory Association (ACLA) and Association of American Pathologists (AMP), the outcome of the election, and the potential for congressional action all have the potential to impact regulations for LDTs. Some key considerations and potential outcomes are outlined in this set of frequently asked questions.
Q1: When will we have an answer about the lawsuit?
The court has asked for all briefs related to the suit to be submitted by the end of 2024, so we will not see an answer before next year. Legal experts have speculated that a judgement is likely by the end of Q1 2025. This would be only a few months from the first deadline of the final rule (May 6, 2025).
Q2: What happens if ACLA/AMP win their lawsuit?
This question seems like it should have a straightforward answer, but in reality, there are a few different possibilities. The ACLA and AMP lawsuits all have several different arguments and how each argument is deciphered by the judge could change the impact of the outcome.
For example, the court could rule that LDTs are not IVDs. This result would essentially halt the final rule and make FDA action on LDTs impossible without Congressional action. Alternately, the ruling could rule in favor of the ACLA and AMP but for a different reason, such as that the cost impact is too high for FDA to move forward. In this case, the court has not stated whether FDA has authority to regulate LDTs but strikes down the rule for other reasons leaving the door open for FDA to regulate through a similar path in the future.
The industry will have to react to the judgement and the specific language, once it is issued.
Q3: What happens if FDA wins their lawsuit?
If FDA wins the lawsuit, the final rule moves forward as it is published with the first deadline being May 6, 2025. This ruling could leave laboratories who waited to start LDT transition planning in a very tough position, with little time to make the necessary changes to meet the phase 1 requirements.
Q4: What if the lawsuit isn’t resolved before May 6, 2025 or the decision is appealed?
Everybody’s favorite answer: it depends!
At this point, neither AMP or ACLA has asked for an injunction on the final rule, which would prevent FDA from moving forward with implementation. So, if the summary judgement is still pending, as it stands today the final rule will move forward and the phase 1 deadline will stand. It is also possible that the injunction will be requested as the deadline approaches.
If FDA wins the lawsuit, the ACLA/AMP can appeal the decision, but the rule would move forward with phase 1 deadline. AMP/ACLA may request an injunction as the appeal plays out in court.
If AMP/ACLA win the lawsuit, the final rule will be halted and the phase 1 deadline will not apply. FDA may or may not seek appeal but regardless the requirements for phase 1 would not apply in May 2025.
Q5: What about the election?
The election could have a potentially large impact on the future of the LDT final rule, as the agency leadership is typically replaced when the President changes. With Joe Biden not pursuing reelection, we will see a new President in 2025. Depending on who is elected, and who is subsequently appointed to lead FDA, FDA may take a step back from enforcing the rule or pursuing appeals on the lawsuit if they lose.
Q6: Will we see the return of the VALID act?
The VALID Act has seen a resurgence in Congress, with a new 2024 version currently being circulated. The contents of this new version are not public but it is clear that Congress is taking some action towards legislation. We may see this effort come back into play as the lawsuit unfurls, but the timeline for congressional action is quite long so it is not expected that new legislation will be passed before the lawsuit judgement or the phase 1 deadline.
Q7: What should laboratories be doing?
If anything is certain for the LDTs today it is that nothing is certain. Laboratories should take a conservative approach to ensure that they remain in compliance and do not phase any consequences of being ill-prepared should the final rule move forward. RQM+ recommends two specific activities for laboratories to complete in 2024, and can help support organizations in these efforts:
- Assess your test menu, understand how the final rule applies to your organization, and document your approach for compliance.
- Understand the changes that are required for phase 1. It is imperative that organizations do not wait until the lawsuit is concluded to start this process as there will not be enough time to implement all of the requirements ahead of the deadline.
Still have questions? Connect with us on LinkedIn or contact us directly. Our RQM+ experts are developing more resources to support your LDT transition. Sign up for our IVD IntelHub Newsletter for quarterly updates on all things IVDs!
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