The Supreme Court heard oral arguments in the pivotal FDA PMTA case. We analyze the justices' questions and what they may signal for the forthcoming decision.
On December 2, 2024, the Supreme Court of the United States heard oral arguments in FDA v. Wages and White Lion Investments, LLC. For over an hour, the justices questioned both sides about fundamental issues of regulatory fairness and agency conduct.
Inside the Courtroom
The oral argument lasted approximately 80 minutes, with justices from across the ideological spectrum engaging deeply with the issues. Several key themes emerged from the questioning:
Questions for the FDA
Multiple justices pressed the government's attorney on the FDA's shifting requirements:
- Why did FDA guidance suggest certain evidence would be sufficient, only to require different evidence later?
- How can manufacturers reasonably comply if standards change after submission?
- Why were marketing plans—which the FDA itself called "critical"—apparently ignored?
"If an agency says one thing in its guidance and does another in its decisions, how is that not a textbook case of arbitrary action?"
Questions for Industry
The justices also probed our position:
- Did manufacturers have actual notice that clinical studies might be required?
- What role should courts play in second-guessing agency scientific judgments?
- How should the Court balance public health concerns with regulatory fairness?
Expert Analysis
Legal observers noted that the justices seemed skeptical of the FDA's position that it had been consistent in its requirements. Several justices appeared troubled by the evidence showing the FDA had called marketing plans "critical" in public meetings, yet apparently did not consider them when reviewing applications.
What the Questions May Signal
While predicting Supreme Court outcomes is notoriously difficult, the questioning suggested:
- Broad concern about regulatory consistency across the Court
- Interest in establishing clear principles for agency conduct
- Attention to the practical impact on small businesses
What Comes Next
A decision is expected by the end of the Court's term, likely in spring 2025. Whatever the outcome, this case will set important precedent for how regulatory agencies must treat those they regulate.
We are grateful for the opportunity to have our case heard by the nation's highest court and remain confident that the principles of fair notice and consistent treatment will prevail.