Coronavirus Product Communications Would Get Safe Harbor Under Senate Bill
In what could be the first major use of the Emergency Use Authorization pathway, manufacturers would be able to disseminate information based on ‘competent and reliable scientific evidence’ that is truthful, non-misleading and directed at population-level decision makers. The measure would define the CARSE standard in the FD&C Act for first time, attorneys say.
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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.
Early versions of US Congress's coronavirus relief bill contained a number of policies that would have benefited drug firms, but they didn't make it into the final bill. However, the $2 trillion package does provide pharmaceutical companies with relief from the threat of drug pricing reform until after the 2020 elections.
If the President says over and over again that a drug is approved, does that make it so?