Emergency Approvals for COVID-19: Evolving Impact on Obligations to Patients in Clinical Care and Research
Holly Fernandez Lynch, Alison Bateman-House, Steven Joffe
Abstract
There currently is debate regarding whether U.S. institutions and clinicians may or should restrict patient access to COVID-19 drugs and vaccines that have been granted emergency use authorization by the U.S. Food and Drug Administration. The authors provide their views on the legal, ethical, and clinical ramifications of such restriction.
Topics & Concepts
MedicineClinical trialConvalescent plasmaFood and drug administrationEmergency departmentCoronavirus disease 2019 (COVID-19)Expanded accessAuthorizationFamily medicineDiseaseMedical emergencyInternal medicinePsychiatryInfectious disease (medical specialty)Computer scienceComputer securityHealthcare cost, quality, practicesHealthcare Decision-Making and RestraintsEthics and Legal Issues in Pediatric Healthcare