Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Hydroxychloroquine EUA Is First Rx Victim Of Hahn’s ‘Move Fast, Course Correct’ Philosophy

Executive Summary

US FDA's decision to revoke the COVID-19 emergency use authorization for two anti-malarial drugs keeps with commissioner Hahn's stated goal of moving fast to tackle the pandemic, but shifting course as new data comes available. FDA cited new evidence as well as a reanalysis of the data it initially based the EUA on as reasons for pulling the authorization. Meanwhile, HHS Secretary Alex Azar appeared to equate the EUA revocation as opening the doors for broader use of the medicine, potentially undermining FDA's own communication on the drug, in yet another example of political leaders complicating the science and public health response to COVID-19.

You may also be interested in...



Research Preprints: Pharma’s Slow Embrace And Predicament

Pharma appears to be treading carefully when it comes to research preprints but COVID-19 has spotlighted the role of these pre-peer-reviewed papers during public health emergencies.

From EUA To Full Approval: CDER, CBER Still Developing Transition Plans

US FDA drug center is evaluating how to handle the end of the coronavirus public health emergency, which would mean unapproved products would no longer be available, but officials likely have plenty of time to consider options.

FDA Chief Counsel Defends COVID-19 EUAs, Praises ‘Moral Strength’ Of Commissioner Hahn

Stacy Cline Amin says authorizing or licensing a COVID-19 vaccine is ‘perhaps the most consequential action the agency will ever take.’ Speaking at FDLI conference, she notes that standards for vaccine EUA will be higher than what has been required for therapeutics.

Related Content

Topics

UsernamePublicRestriction

Register

LL1126230

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel