US FDA Extends Payor Communications Safe Harbor To Off-Label Uses
Final guidance on drug manufacturer communications with payors adopts industry call to include exchanges about unapproved uses; they will not be considered evidence of intended use.
You may also be interested in...
Preapproval Information Exchange With Payers: Guidelines Codified In Omnibus Spending Bill
Legislation, known as PIE Act, does not force manufacturers to share information on pricing or economic models with payers but aligns with the requirements in US Food and Drug Administration guidance.
Preapproval Information Exchange Between Sponsors, Insurers Clarified In House User Fee Bill
By codifying FDA guidance, pending legislation aims to encourage industry to become more comfortable with even unsolicited communications to payers about investigational drugs.
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.