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.
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Drug Promotion: FDA Loosens Reins But Industry Wants More Room To Run
Agency proposes a safe harbor for certain communications with payers about approved uses and investigational drugs, but drug manufacturers ask the US agency to expressly protect from enforcement manufacturer communications about off-label uses.
Rx For Industry: Key Provisions Of The 21st Century Cures Act
Changes to the priority review voucher program, economic communications with payors, and approval of antimicrobial products all have the potential to impact the commercial prospects of drugmakers.
Payers Want Access To US FDA's Pre-Submission Meetings
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.