Health Law Daily Wrap Up, ADMINISTRATION OF FDC ACT—D. Md.: Attempt to require FDA to skip premarket efficacy studies for Alzheimer’s drugs dismissed, (Oct 15, 2024)

By Patricia K. Ruiz, J.D.

The court found that the universal nature of the harm alleged by the plaintiff prevented him from establishing standing.

The U.S. District Court for the District of Maryland granted a motion to dismiss by the FDA in a pro se lawsuit seeking to require the FDA to approve certain protocols allowing potential therapeutic drugs to be used in combination to treat Alzheimer’s disease. The court cited the separation of powers, as protected by the standing doctrine, in declining to order the FDA to sidestep its premarket approval process (Zhang v. FDA, No. SAG-23-1188 (D. Md. Oct. 8, 2024)).

Allegations. Dozens of potential treatments for Alzheimer’s disease have passed the FDA’s safety test but have failed to show efficacy in Phase III clinical trials, which are required for FDA approval. An individual submitted a citizen petition to the FDA requesting that it approve, with only a demonstration of safety and not pre-market studies of efficacy, Potential Therapeutic Drugs (PTDs) intended to treat Alzheimer’s and other patients with medical conditions currently without any effective medication. The plaintiff believes the odds of discovering an effective combination of treatments would be much higher if such a practice were allowed, given the exorbitant costs of clinical trials for drug combinations. The FDA denied his petition, resulting in this pro se lawsuit.

Establishing standing. The FDA moved to dismiss, asserting the plaintiff lacks standing to sue. To ensure federal courts do not encroach on the purview of the legislative or executive branches, under Article III of the U.S. Constitution, standing exists only where questions are presented in an adversary context. Thus, the plaintiff’s complaint must include factual allegations to plausibly establish (1) the plaintiff suffered an injury in fact that is concrete and particularized and actual or imminent, not conjectural or hypothetical; (2) that his injury is fairly traceable to the challenged action of the defendant; and (3) that his injury is capable of redress by a favorable decision.

No concrete and particularized injury. The court found that the plaintiff failed to make any factual allegations suggesting he has suffered any concrete and particularized injury from the FDA’s drug approval process. The court noted that the plaintiff acknowledged that he is in the same position as the general population with respect to the potential risk of future injury, having alleged that “[e]veryone is likely to suffer from [Alzheimer’s], especially people aged over 65,” and that “millions of people are suffering” from the disease” and “many more will be diagnosed soon.” The plaintiff further alleged that he “has likelihood to suffer from it.” The universal nature of the potential harm prevents the plaintiff from asserting the type of particularized injury the law requires, the court found, as such an injury must affect the plaintiff in a personal and individual way. The injury asserted to establish standing cannot be an undifferentiated, generalized grievance that all citizens share. Because of the general nature of the injury alleged, the court granted FDA’s motion to dismiss.

The case is No. SAG-23-1188.

Judge: Gallagher, S.

Attorneys: Jianyi Zhang, pro se. James William Harlow, U.S. Department of Justice, for U.S. Food and Drug Administration.

Companies: U.S. Food and Drug Administration

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