Off-Label Communication Principles From PhRMA, BIO Aim For Reg Changes
Manufacturer communications with providers and payers could include real-world evidence and pharmacoeconomic information, associations urge.
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‘Competent and reliable scientific evidence’ standard for payer communications also should apply to medical product communications that are consistent with labeling, manufacturers say in comments on US FDA draft guidance documents.
Sponsors and payers question guidances' scope and potential audiences, and wonder if the agency couldn't just perform some retrospective audits of off-label communication to speed things up.
Payer- and physician-directed communications would be best addressed through a regulatory 'safe harbor' rather than First Amendment challenges where the outcome might sweep up consumer-directed communications, lawyers say at FDA/CMS Summit.