Sen Cassidy Chevron LDT Letter

Senator Cassidy's letter to FDA (6/30/2024) re CHEVRON decision, including impact on FDA-LDT regulation.   Link to original 5p PDF and to Dr Stanley Lo's posting, at bottom.

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Senator Bill Cassidy's letter to the FDA, dated June 30, 2024, addresses significant changes resulting from the Supreme Court's decision in Loper Bright Enterprises v. Raimondo, which overturned the Chevron deference. This decision mandates that courts no longer defer to federal agencies' interpretations of ambiguous statutory provisions, thereby restoring Congress's and the courts' roles in writing and interpreting laws.

Senator Cassidy urges the FDA to reassess its role in light of this ruling, emphasizing that agencies should not exceed their authority granted by Congress. He highlights specific concerns regarding the FDA's unilateral assertion of jurisdiction over laboratory-developed tests (LDTs) without clear congressional authorization and its disregard for court rulings on the Orphan Drug Act.

The letter calls for the FDA to answer several questions by July 19, 2024, detailing how it plans to adjust its practices to comply with the new legal framework, facilitate greater congressional involvement, and improve responsiveness to oversight and technical assistance requests. Senator Cassidy stresses the importance of the FDA adhering strictly to the laws enacted by Congress and not overstepping its regulatory authority.

Senator Cassidy asks the FDA the following questions in his letter:

1. Compliance with Congressional Laws: How will the FDA adjust its practices to enforce laws as written by Congress, avoiding improper legislation through agency action?

   • Will there be a systematic review of ongoing activities to identify necessary changes?
   • Will any rulemaking activities be paused or stopped in light of the Supreme Court's decision?

2. Congressional Involvement: How does the FDA plan to enhance congressional involvement in policy issues under its jurisdiction? Please specify plans for oversight, briefings, trainings, seminars, and other actions.

3. Briefing Policies: What are the FDA’s current policies on when staff may or may not provide briefings to congressional staff? Under what circumstances would the FDA refuse a briefing request, and where are these policies codified?

4. Responsiveness to Oversight: How will the FDA improve its responsiveness to oversight and technical assistance requests from Congress?

   • How will the process for clearing technical assistance be streamlined to reduce response times?

5. Substantive Responses: Will the FDA commit to providing substantive responses to congressional oversight requests within 30 days of receipt? If not, why?

6. LDT Regulation: How will the FDA apply the Supreme Court’s decision to its actions related to the regulation of laboratory-developed tests (LDTs), given the lack of clear congressional authority?

7. Court Decision Compliance: Following the Catalyst decision regarding orphan drug exclusivity, what criteria does the FDA use to determine when it will follow or ignore a court decision? Include details on how the status of the deciding court (district vs. appellate) and any relevant congressional legislation are considered.

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