Pink Sheet 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

UsernamePublicRestriction
UsernamePublicRestriction

The Consequences of Caronia: Impact On FDA’s Off-Label Regulation

This article was originally published in RPM Report

Executive Summary

The government has decided not to appeal the Second Circuit’s Caronia off-label promotion ruling – no doubt in part because of concerns about the broad reading of the First Amendment currently in favor at the Supreme Court. Officially, FDA has adopted a low-key response. Unofficially, agency officials – notably Bob Temple – are outraged by the ruling. What does Caronia mean for the future of FDA regulation and off-label prosecutions?

Advertisement

Related Content

FDA Reassessing Off-Label Policies To Address First Amendment Concerns
Endo Lidoderm Settlements: “Golden Goose” Hatches Strong Case
A Regulator’s Perspective For 2013: FDA’s Temple Discusses FDASIA, Caronia, and Breakthrough Development
FDA’s Very Big Year: Drug Approvals Approach Record Levels
Off-Label Enforcement, Not Promotion, May See First Changes After Free Speech Ruling
GSK’s DoJ Settlement Links Executive Bonus To Continued Compliance
FDA’s Social Media Guidance: As Industry Waits, How Watchful Should It Be?
Off-Label Use Discussions Should Stay Off-line, FDA Draft Guidance Says
REMS Use Declining, But Post-Marketing Requirements Remain
Off-Label Sales in Jeopardy: Rx Industry Fights for Clarity

Topics

Related Companies

Advertisement
UsernamePublicRestriction

Register

PS081102

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