Off-Label Promoter In Chief: President Trump Pushes COVID-19 Therapy
If the President says over and over again that a drug is approved, does that make it so?
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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.
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.
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?