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.
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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.
Process for sharing health care economic and other information has been simplified for manufacturers, and payers are seeing more economic modeling data earlier as a result. However, there is still uncertainty as to the scope of who may communicate the information, and to whom, under the agency’s 2018 final guidance, experts said.
Dozen drug pricing transparency bills enacted into law over past two years impose different requirements on manufacturers, with a few honing in on PBMs; interactive graphic details these and other pharma-related laws.