Title:Exploration & Outcomes of Emergency Use Authorization during the
COVID-19 Pandemic in the United States
Volume: 2
Author(s): Simran Simran, Sabanis Chetan Dushant, Joga Ramesh and Sandeep Kumar*
Affiliation:
- Department of Regulatory Affairs, National Institute of Pharmaceutical Education and Research (NIPER), Hyderabad, India
Keywords:
Emergency use authorization, COVID-19 pandemic, Current good manufacturing practice exemption, Expiry date extension, Emergency use authorization revoke, WHO.
Abstract: The COVID-19 emergency built pressure on US regulatory bodies to unlock the optional and short pathway of approval for urgently required
pharmaceuticals to accomplish population demand for medicinal products within the shortest possible time to limit the suffering and deaths
associated with insufficiency of medicinal products in need. During the pandemic, many medicinal products got emergency use authorization
(EUA) according to the EUA guidelines provided by the US Food Drug Administration (USFDA). The requirement of abbreviated data submission
for EUA attracted many pharmaceutical companies to launch their products as investigational drugs. Clinical data collected from the population is
also permitted to get final approval. Comirnaty and Remdesivir got full approval using this regulatory tool. EUA does not ensure the existence of
the medicinal product for an extended period. Whenever the emergency is over or the products are no longer needed, the USFDA revokes those
according to their legislation. However, after Hydroxychloroquine phosphate and chloroquine sulfate were revoked due to failure to show efficacy,
it grabbed the attention of many healthcare stakeholders in the country. It demanded more transparency in the approval pathway of present EUA
guidelines. Two attributes, i.e., Current Good Manufacturing Practice exemption and expiry date extension, affect the quality of the medicinal
products used during the pandemic. The most critical product distribution data, voluntary in EUA, remarkably endorse the black-marketing and
shortage of specific COVID-19-related medicinal products in the pandemic situation. Amendments to the existing guidelines minimize the
upcoming public health risk.
