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


Off-Label Prosecutions Hinge On Patient Benefit, Government Attorneys Say

Executive Summary

Federal prosecutors say they will not pursue False Claims Act cases in which off-label use is the standard of care and note that the Caronia decision will have little impact on investigations; First Amendment defense fails in Par and Harkonen cases.


Related Content

FDA First Amendment Litigation: Will Amarin Case Break The Log Jam?
People In The News: New Top Management At Vivus, Merck Serono; Obama Nominates New ASPE at HHS
Par’s Off-Label Plea Deal Includes Clawback For Execs’ Pay In Case Of Future Misconduct
Pfizer Settles Protonix Off-Label Allegations – Pricing Investigation Still Unresolved
Off-Label Enforcement, Not Promotion, May See First Changes After Free Speech Ruling
PhRMA Offers “No Reasonable Expert” Standard For Addressing Fraud Charges
Former InterMune CEO Sentenced To Probation, DoJ Reindicts Former GSK Attorney


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