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


FDA Prosecution Criteria For “Responsible” Execs Includes Seriousness, Obviousness Of Violations

Executive Summary

Almost a year after signaling its intent to target more individual executives with misdemeanor prosecutions when their companies have broken the law, FDA has published its criteria for pursuing such cases.

You may also be interested in...

Park Doctrine’s Use Should Hinge On Individual’s Knowledge Of Wrongdoing, Prosecutor Says

Application of the Park doctrine to hold corporate officers strictly liable should depend upon an individual’s knowledge of wrongdoing committed under the Food, Drug and Cosmetic Act, Assistant U.S. Attorney for the District of Massachusetts Sara Bloom tells a compliance conference.

Park Doctrine Could Be Limited By Upcoming Cases, Attorney Argues

As penalties increase under responsible corporate officer doctrine, attorney Allison Burroughs, a partner at Nutter McClennen & Fish, says to expect increased scrutiny.

Former KV Pharmaceutical CEO Sentenced To 30 Days In Jail

Marc Hermelin pleads guilty to distributing oversized morphine sulfate tablets; he may be first pharma exec to be jailed for healthcare fraud.

Related Content





Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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