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If you track the FDA LDT proposed regulation, you've probably heard about May 22, 2024, as a magic date by which FDA will finalize the rule. What's up?
The date points to the Congressional Review Act, or CRA. When an agency proposes a new regulation, Congress essentially has a few months to annul it through a special procedure. The CRA will cancel a new regulation, if the canceling motion is passed by a majority of both House and Senate and signed by the President. See discussion at "The Nickel Report" here.
As explained in that article, if new regulations are passed after May 22, 2024, they will be "new enough" that the new Congress (House and Senate) and new President (if that happens) can reject the regulations by CRA. If regualtions are passed BEFORE May 22, 2024, they will be "old enough" that a CRA action in 2025 won't be available any more.
The CRA dates to 1996 (see 2023 update from Congressional Research Service here.)
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As of the 2023 CRS report, the CRA had been used once in 2001, 16 times in 2017, and 3 times in 2021. The CRA is relatively speedy since it requires a simple majority for a "joint resolution."
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With regards to the FDA LDT rule, if we have a Republican House and Senate, and they care enough about the LDT regulation to undo it with CRA, it would still have to be signed by the President, and if we have the same President, he might be unlikely to do so.
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Even without the CRA, and regardless of the date of the FDA final rule, a new administration could undo it without iinvoking the CRA or requiring agreement on the Hill. For example, if it wanted to (and I don't have an opinion on that), a Trump administration could appoint a new Comissioner of FDA and they could put out a regulation reversing the FDA LDT regulation. It would have to meet pro forma requirements, specifically, having a discussion of the reason for the reversal, and take public comment for 30 days, but it's not technically difficult. If the FDA LDT rule is completed in the next few weeks, and therefore falls outside of the CRA (not for this Congress, but for the next one), the FDA LDT rule could still be undone through rulemaking.
Even without the CRA, and regardless of the date of the FDA final rule, a new administration could undo it without iinvoking the CRA or requiring agreement on the Hill. For example, if it wanted to (and I don't have an opinion on that), a Trump administration could appoint a new Comissioner of FDA and they could put out a regulation reversing the FDA LDT regulation. It would have to meet pro forma requirements, specifically, having a discussion of the reason for the reversal, and take public comment for 30 days, but it's not technically difficult. If the FDA LDT rule is completed in the next few weeks, and therefore falls outside of the CRA (not for this Congress, but for the next one), the FDA LDT rule could still be undone through rulemaking.
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Even without a rulemaking reversal, and regardless of the makeup of Congress, the FDA LDT regulation is likely to have a legal challenge, and a new administration could determine it will not fight, or do little to fight, the legal challenge by the rule's opponents. Attorneys like lab policy expert Dr Roger Klein have opined the legal challenge has a good chance of achieving an injunction (here).
Even without a rulemaking reversal, and regardless of the makeup of Congress, the FDA LDT regulation is likely to have a legal challenge, and a new administration could determine it will not fight, or do little to fight, the legal challenge by the rule's opponents. Attorneys like lab policy expert Dr Roger Klein have opined the legal challenge has a good chance of achieving an injunction (here).
