Industry's Off-Label Hearing Priorities Taking Shape
Pfizer attorney raises impact on research and other key themes for the upcoming FDA public hearing.
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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.
As sponsors push for more access to physicians, payers hope to be able to gather more pre-approval information about drugs – like they now can with devices – for budgeting and patient access.
A drumbeat of court cases – and now a change in presidential administrations – signals that regulations on off-label communications need to change; but FDA still seems unsure how to relax its grip without letting go completely.