Court Dismisses Suit Seeking FDA Pathway for Alzheimer’s
A Maryland federal judge has dismissed a physician’s bid to force FDA to create a special, conditional access pathway for certain experimental Alzheimer’s treatments, holding that the doctor lacked standing to sue.
Maryland physician Jianyi Zhang sued FDA “on behalf of millions of individuals” with Alzheimer’s disease and related neurological disorders. Zhang had previously filed a citizen petition asking FDA to establish a regulatory pathway for “Potential Therapeutic Drugs” (PTDs) that failed Phase 3 trials but, in his view, are safe and might work in combination with other therapies. He asked the court to compel FDA to modify its drug approval framework to allow PTDs to be conditionally marketed with strict post‑market surveillance, and sought review under the Administrative Procedure Act, as well as constitutional due process and equal protection theories.
FDA had already denied the citizen petition on the grounds that “no scientific data supports the efficacy of PTDs,” and then moved to dismiss Zhang’s new case. The agency argued that Zhang had not alleged any concrete, particularized injury and therefore lacked Article III standing, and that he had not stated a plausible claim under the APA or the Constitution.
U.S. district judge Julie R. Rubin framed the decision as a threshold jurisdictional ruling under Federal Rule of Civil Procedure 12(b)(1), which governs motions to dismiss for lack of subject‑matter jurisdiction, including standing. The court distinguished Supreme Court precedents Zhang cited, noting that the cases involved state sovereign interests, recognized forms of associational standing, taxpayer standing in a narrow constitutional context, or denial of access to statutorily required information—not a private physician seeking to vindicate broad public health concerns. By contrast, Zhang had said he was asking for judicial intervention “not on [his] own situation,” but to address a matter affecting millions.
Judge Rubin characterized that as precisely the kind of “abstract general interest common to all members of the public” that the Supreme Court has said cannot support standing, even when a plaintiff is “sincere or deeply committed” to the cause. The opinion quoted and echoed an earlier dismissal by another judge in Zhang’s previous case, which found that the “universal nature of the potential harm” from Alzheimer’s disease prevented him from alleging the individualized injury the law requires.