Scrip is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Off-Label Communication: Pfizer Highlights Burdens Of FDA Policy

Executive Summary

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.


Related Content

Drug Promotion: FDA Loosens Reins But Industry Wants More Room To Run
Rx For Industry: Key Provisions Of The 21st Century Cures Act
Payers Want Access To US FDA's Pre-Submission Meetings
Off-Label Communication Growth: Could FDA Afford To Police It?
Keep Limits On Off-Label Promotion, Consumers And Patients Say
Off-Label Communications: Industry, FDA Debate Role Of Peer Review
FDA's Drug Promotion Advisory Reviews Taking Longer
Off-Label Preclearance Process Eyed As Potential Fix For FDA's Policy Dilemma
FDA Promises More Off-label Guidances As Part Of First Amendment Harmonization


Related Companies




Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts