Off-Label Promotion Decisions Likely Made Case-by-Case, US FDA Official Says
OPDP chief Abrams did not give many general tips for complying with guidance on off-label promotion 'consistent with' FDA-approved labeling, leaving sponsors to make own interpretations.
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Office of Prescription Drug Promotion is focused on most egregious issues where human safety is at stake; CDER's Woodcock also says that First Amendment issues are affecting enforcement.
US agency's Office of Prescription Drug Promotion may complete 37% fewer drug promotional material reviews in FY 2017 than previous year.
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.