Skip to main content

McMillin Talks to Inside Health Policy on Senate Resolution to Overturn FDA LDT Rule

May 24, 2024

Bobby McMillin, managing director of the firm’s Legislative & Public Policy practice, was quoted in the Inside Health Policy article, “Rand Paul’s Congressional Review Resolution Would Overrule LDT Rule.” The article discusses the Senate resolution recently introduced by Sen. Rand Paul (R-Ky.) under the Congressional Review Act (CRA) with the goal of overturning the U.S. Food and Drug Administration’s final rule on the regulation of laboratory-developed tests (LDTs). The final rule, which would reform the administration’s oversight over laboratory developed tests (LDTs), was finalized at the end of April to avoid invalidation attempts under the Congressional Review Act’s (CRA) “midnight rule.”

McMillin told Inside Health Policy that the FDA was smart to finalize the rule “well in advance” of the CRA’s review period. “If they had held on finalizing until later this summer or fall, the rule might have been vulnerable to being overturned if Republicans win the presidency, the House, and the Senate in November’s elections,” he said.

However, because of the timing of the final rule’s release there likely “won’t be an opportunity to reverse the rule using the Congressional Review Act next Congress no matter what happens in November,” McMillin said. However, the Senate could still vote on the resolution to allow members the opportunity to “signal their opposition to a rule using a CRA resolution,” McMillin said, something that is especially true with the FDA’s LDT rule because it drew a lot of attention.

Read the full article.