FDA Promises More Off-label Guidances As Part Of First Amendment Harmonization
This article was originally published in The Pink Sheet Daily
Executive Summary
Agency grants two citizen petitions from a coalition of pharma companies requesting greater clarity from FDA, but whether the forthcoming guidances will satisfy industry remains an open question.
You may also be interested in...
Off-Label Communication: Pfizer Highlights Burdens Of FDA Policy
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.
Off-Label Communications: Industry, FDA Debate Role Of Peer Review
Allowing manufacturers to share research on unapproved uses that has not been formally vetted and published raises transparency concerns, US FDA commissioner says; industry attorney counters that many useful data sources 'would never see the light of day' under current peer review approaches.
Off-Label Questions Linger: How Much Data Needed To Be 'Truthful'?
FDA settlement with Amarin on Vascepa has done little to clarify what constitutes 'non-misleading' communications about an unapproved use.