Keep Limits On Off-Label Promotion, Consumers And Patients Say
Prescribers can get information they need through continuing education programs and scientific conferences, non-industry stakeholders tell US FDA during second day of meeting on manufacturer communications for unapproved uses.
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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.
Seeking relaxation of US agency restrictions, Pfizer cites three examples where company delayed or decided against distributing medically relevant information beyond the product labeling; PhRMA survey shows almost half of all requests for information by prescribers and payers relate to off-label use.