Pink Sheet is part 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

UsernamePublicRestriction
UsernamePublicRestriction

What To Do About Caronia

This article was originally published in RPM Report

Executive Summary

While pharmaceutical marketers wait to hear how the government will respond to the Second Circuit’s off-label communication Caronia court ruling, PhRMA is considering ways to take the initiative. On the table: working proactively with FDA to re-frame the rules around off-label promotion.

You may also be interested in...



Off-label Ruling’s Potential Fallout Is “Terrifying,” FDA’s Temple Says

If firms could promote drugs for uses not backed by well-controlled studies, it would be “a nightmare,” Temple says; AEI’s Scott Gottlieb suggests the agency might try to regulate how medicines are prescribed.

Off-Label Enforcement, Not Promotion, May See First Changes After Free Speech Ruling

In a watershed decision, a federal appeals court declares that manufacturers cannot be prosecuted under the FD&C Act’s misbranding provisions solely for speech promoting off-label use of a drug. Industry attorneys predict the decision, if it stands, will change the government’s approach to pursuing such cases.

US FDA’s Inner Circle Takes Shape: Shah Seen As Potential Successor To Abernethy

Anand Shah returns to FDA as deputy commissioner; like Abernethy, he is an oncologist with a background in big data.

Topics

Related Companies

UsernamePublicRestriction

Register

PS081093

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

Cancel