EUA restriction for hospitalized patients was basis for lawsuit that advanced several arguments.
Issue of the Case
After the FDA issued an emergency use authorization (EUA) for a COVID-19 drug but limited its use to hospital inpatients, the association of American Physicians and Surgeons (AAPS) mounted a legal challenge. Did it prevail?
Facts of the Case
From March 28 to June 15, 2020, the FDA issued an EUA to hydroxychloroquine for the treatment of COVID-19, specifying that the drug could be used only in adult and adolescent patients who were admitted to a hospital, weighed at least 50 kg, and were unable participate in a clinical trial.
The AAPS filed suit in federal district court against the FDA commissioner and other federal government officials challenging the EUA’s restriction to hospitalized patients.
The organization argued, first, that the action violated the implied equal protection guaranteed by the Fifth Amendment; second, that it violated the First Amendment right to association by interfering with access to medication that would facilitate the meeting of groups during the pandemic; third, that the AAPS was considering canceling a conference because of the restrictions; and finally, that the association had “third-party standing” because the patients of its members could not obtain the medication for treatment.
The federal trial court dismissed the plaintiff’s lawsuit because it lacked standing.
Locus standi is the legal principle that to appear in court, a plaintiff must show that the conduct in question invades or will invade a legally protected interest of the plaintiff’s. The association appealed the trial court’s dismissal to the relevant federal circuit court of appeals.
The relevant US court of appeals affirmed the decision of the trial court judge.
The Court's Reasoning
The appellate court pointed out that the EUA was limited in scope because it granted access only to supplies of the medication in the Strategic National Stockpile (SNS) under specified circumstances, ie, to patients above a certain weight hospitalized with COVID-19.
Furthermore, the issue had become moot because the FDA rescinded the EUA less than 3 months after issuing it (while proceedings were progressing), when new data indicated that the medication was ineffective against COVID-19.
The association had alleged injury in that it might be forced to cancel a conference. The trial court rejected this argument, saying that it was unlikely the EUA would cause said injury. Rather, state-imposed limitations on large gatherings would be the basis for not holding a conference. The court of appeals concurred.The issue of standing was taken up next.
The court pointed out that to establish standing, the organization must do more than allege the likelihood that the defendant’s conduct would harm an unknown member of the organization. Rather, it must identify a member who had suffered a concrete and specific injury as a result of the defendant’s action and show that the relief being sought would redress the injury.
The association had argued that the EUA directly restricted its members from prescribing the drug in their preferred fashion and could result in members’ facing sanctions at the state level for prescribing the product for that use.
The appellate court pointed out that the EUA did not bar physicians from prescribing hydroxychloroquine to patients who were not hospitalized. It did not address or attempt to regulate physicians’ prescribing decisions. It was directed at governing the distribution of the medication from the SNS. Hence, the EUA had no adverse effect on physician-members’ ability to prescribe the drug to patients, who would be able to obtain it through nongovernmental channels. The appellate judges emphasized that the Federal Food, Drug, and Cosmetic Act is directed at regulating drug distribution and does not bar prescribers from off-label prescribing, as would be the case here.
The appellate judges labeled as pure speculation the association’s assertion that a state medical licensure board might pursue disciplinary action against a physician-member for prescribing the drug. The association had pointed to no provision in state law that would be infringed by a physician’s prescribing the drug in a way other than what was specified in the EUA. Overall, the association had alleged no direct injury to itself, thus lacking standing and leading to affirmation of the trial court’s dismissal.
About the Author
Joseph L. Fink III, JD, DSc (Hon), BSPharm, FAPhA, is professor emeritus of pharmacy law and policy at the University of Kentucky College of Pharmacy in Lexington.