Law School Questions

 

Write three essay questions for a third-year law student course on health & regulatory law, where this case was a major teaching case this semester.

Essay Question 1: Regulatory Jurisdiction and Statutory Interpretation

The FDA's assertion of regulatory authority over laboratory-developed tests (LDTs) has been challenged by both ACLA and AMP on statutory and jurisdictional grounds. Drawing from their arguments and relevant statutory language, address the following:

• Discuss the jurisdictional boundaries between CLIA and the FDCA. How does this case illustrate the challenges of overlapping regulatory frameworks?
• Evaluate the FDA’s interpretation of LDTs as "devices" under the FDCA. Is this interpretation consistent with the statutory language and legislative intent? Why or why not?
• Apply the major questions doctrine to this case. Should the FDA’s regulation of LDTs fall under this doctrine, and if so, why does it matter?

In your response, consider both the practical implications for laboratories and the legal principles governing agency authority.

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Essay Question 2: Economic and Public Health Implications of Regulatory Overreach

Both ACLA and AMP emphasize the economic and public health impacts of the FDA’s rule. In a well-structured essay, analyze:

• How does the rule’s potential economic burden on laboratories weigh against the FDA's stated goals of ensuring patient safety and test accuracy?
• Do the existing CLIA regulations adequately address concerns about the analytical and clinical validity of LDTs, or is there a compelling need for FDA oversight?
• Consider how the rule might disproportionately affect smaller laboratories or those serving underserved populations. What broader public health issues could arise?

Use examples from the briefs and discuss whether the FDA adequately justified its position in light of these consequences.

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Essay Question 3: The Role of Enforcement Discretion in Administrative Law

The FDA has historically used enforcement discretion to regulate LDTs, a point heavily critiqued in the ACLA and AMP briefs. Write an essay discussing:

• What is the legal and practical role of enforcement discretion in administrative law?
• How does the FDA's reliance on enforcement discretion to mitigate the impacts of its LDT rule affect its credibility and the clarity of its regulatory framework?
• Should courts view reliance on enforcement discretion as a strength or a weakness in agency rulemaking? Justify your position with reference to this case and broader principles of administrative law.

In your response, address how the courts might balance the flexibility of enforcement discretion with the need for predictability and fairness in regulation.