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

Off-Label Promoter In Chief: President Trump Pushes COVID-19 Therapy

Executive Summary

If the President says over and over again that a drug is approved, does that make it so?

You may also be interested in...



Remdesivir EUA Includes Promotional Limitations Absent From Chloroquine Authorization

Printed materials and promotions must describe Gilead’s drug as authorized, not approved, for treating COVID-19; although similar boilerplate restrictions are part of most of the EUAs issued for diagnostics and equipment to combat the novel coronavirus, they were not included in the authorization for chloroquine/hydroxychloroquine. Remdesivir's new website strongly resembles an approved brand product site.

States Take Unusual Actions To Control On-Label Drug Supply Amidst COVID-19 Shortages

Sixteen US states have issued executive orders or other mandatory directives to preserve hydroxychloroquine and chloroquine for non-COVID-19 patients, while 26 states have issued similar voluntary guidance. The federal government is reserving some of the strategic national stockpile supply of the drugs for non-COVID-19, as private players in the supply chain also join in the efforts to balance on-label use with COVID-related demand. 

Supply Chain Truce In COVID-19: Will It Carry Over When Rx Price Debate Resumes?

Manufacturers, insurers, pharmacies and PBMs are united in trying to assure ongoing access to medicines amid the COVID-19 outbreak. Will making common cause in a national emergency mean a more cooperative approach to addressing US drug pricing concerns when normalcy returns?

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS141910

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