Even in “Unprecedented” Times, There is Precedent

The word unprecedented has been used a lot in the past two weeks.  Perhaps appropriately.  Below is some  precedent that’s been on this blogger’s mind recently and that may be relevant in the coming days, weeks, and months:

• Tummino v. Hamburg. Why? The HHS Secretary intervened in an FDA approval decision.  The court ruled the agency’s action was arbitrary and capricious and entered a mandatory injunction ordering FDA to make the drug available.
• Trump v. Hawaii and related cases. Why?  Those litigations discuss the relevance of campaign statements and social media posts in assessing the legality of executive actions.
• Cook v. FDA. Why? The case analyzed when an enforcement obligation was required by statute as opposed to committed to agency discretion.
• FDA v. Alliance for Hippocratic Medicine et al. Why? The Court analyzed constitutional standing requirements, especially in the organizational and associational context.
• Preemption, commerce clause (dormant and otherwise), and related cases, especially those involving state and local government action. Why? Those cases evaluate when state and local governments can act in ways that may be different from the federal government.
• Practice of medicine cases. Why? These cases help inform the jurisdictional bounds of FDA’s authority.
• Cases about the steps the agency must take if it attempts to withdraw an approval. Why? These cases analyze the statutory and regulatory requirements that FDA must follow when considering such actions.
• Cases assessing when FDA has taken final agency action. Why? Those cases analyze when a court will consider a challenge on the merits as opposed to dismissing it on procedural grounds.
• Unreasonable delay cases. Why? Because these cases inform when a party can obtain relief when the agency fails to act.
• Loper Bright. Why? Because it changed the framework that courts will use to resolve statutory ambiguities in the above and other contexts.

Unprecedented or not, we can expect important changes in the coming months.  One thing won’t change, however.  Hyman, Phelps & McNamara, P.C. and the FDA Law Blog will keep our finger on the pulse of developments in the law and our readers informed of how those developments affect them.