Case problem
After the FDA issued an Emergency Use Authorization (EUA) for a COVID-19 drug but restricted its use to hospitalized patients, the Association of American Physicians and Surgeons (AAPS) launched a legal challenge. Has it prevailed?
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Case facts
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 only be used in hospitalized adult and adolescent patients weighing at least 50 kg. and were unable to participate in a clinical study.
The AAPS filed a lawsuit in federal district court against the FDA commissioner and other federal government officials challenging the EUA’s restriction on hospitalized patients.
The organization argued, first, that the action violated the implied equal protection afforded by the Fifth Amendment; second, that it violated the First Amendment right of association by interfering with access to drugs that would make it easier for groups to come together during the pandemic; third, that the AAPS was considering canceling a conference due to restrictions; and finally, that the association had third-party legitimacy because its members’ patients could not obtain the drug for treatment.
The federal court dismissed the plaintiff’s lawsuit because it lacked substantiation.
Locus standi is the legal principle that in order to appear in court, a plaintiff must demonstrate that the conduct in question encroaches or will encroach on a legally protected interest of the plaintiffs. The association filed an appeal against the dismissal of the first instance courts with the competent federal circuit court of appeals.
The sentence
The relevant US appellate court upheld the trial court judge’s decision.
The Court’s reasoning
The appeals court emphasized that the EUA was limited in scope because it only granted access to supplies of the drug in the strategic national stockpile (SNS) under specific circumstances, i.e., to patients over a certain weight hospitalized with COVID-19. 19.
Furthermore, the issue had become moot because the FDA revoked the EUA less than 3 months after it was issued (while the proceeding was pending), when new data indicated that the drug was ineffective against COVID-19.
The association had alleged bias in that it could have been forced to cancel a conference. The trial court rejected this argument, stating that it was unlikely that the EUA would have caused such harm. Rather, state-imposed limitations on large gatherings would be the basis for not holding a conference. The appeals court agreed. Subsequently, the issue of legal standing was addressed.
The court emphasized that to establish standing, the organization must do more than state the likelihood that the defendant’s conduct could harm an unknown member of the organization. Rather, it must identify a member who has suffered concrete and specific harm as a result of the defendant’s action and demonstrate that the compensation sought would have remedied the harm.
The association had argued that the EUA directly restricted its members from prescribing the drug in any way they preferred and could lead to members facing state-level penalties for prescribing the product for such use.
The appeals court emphasized that the EUA did not stop doctors from prescribing hydroxychloroquine to patients who had not been hospitalized. It did not address or attempt to regulate physicians’ prescribing decisions. It was directed to govern the distribution of the drug by the SNS. Thus, the EUA had no adverse effect on the ability of medical members to prescribe the drug to patients, who would have been able to obtain it through non-governmental channels. The appellate judges emphasized that the Federal Food, Drug, and Cosmetic Act is intended to regulate drug distribution and does not prevent prescribers from prescribing off-label, as would be the case in this case.
Appellate judges labeled the associations’ claim that a state medical licensing board could pursue disciplinary action against a member physician for prescribing the drug as pure speculation. The association had not identified any provision in state law that would be violated by a physician prescribing the drug in a manner other than specified in the EUA. Overall, the association had not deduced any direct damage to itself, thus diminishing its legitimacy and determining the affirmation of the rejection by the judges on the merits.
About the author
Joseph L. Fink III, JD, DSc (Hon), BSPharm, FAPhAis Professor Emeritus of Pharmaceutical Law and Policy at the University of Kentucky College of Pharmacy at Lexington.
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