Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

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

Executive Summary

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.

You may also be interested in...



Economic Superiority Claims, Manufacturer/Payer Relationships Ripe For Enforcement Scrutiny

The era of big pharma off-label promotion cases may be coming to a close, but federal prosecutors are eyeing other industry practices for enforcement, including unsupported promotional claims of economic superiority and superior efficacy, and manipulation of the average sales price system.

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

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.

Off-Label Prosecution May Be Where FDA "Parks" Aggressive Enforcement Tools First

FDA appears likely to target flagrant off-label promotion in its first cases under new procedures for using the Park Doctrine and strict liability statutes to prosecute corporate executives and others.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS054176

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

Cancel