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

No Fault? Not Quite

This article was originally published in RPM Report

Executive Summary

An HHS departmental appeals board decision finds Purdue executives at fault despite plea and convictions based solely on the Dotterweich and Park doctrines

You may also be interested in...



No Walk in the Park: FDA Talks Tough about Executive Accountability

If history is any guide, FDA will soon start showing its teeth as a regulatory enforcement agency. That makes this a good time for executives to refresh their memory about the doctrine of strict liability for FD&C Act violations-and to ponder the implications of the Department of Justice's recent use of the so-called Park doctrine against three top execs at Purdue Pharma.

Disease Awareness Information: The Xiaflex Dupuytren's Dilemma

Is FDA trying effectively to ban the practice of providing disease awareness information in promotoional materials? A recent letter to Auxilium on promotional materials for the company's drug for Dupuytren Disease (Xiaflex) suggests FDA is still looking closely at how companies describe disease states compared to a product's labeled indications.

FDA Overreaches in Jurisdictional Power Grab

Letter to Dysport clinical investigator claims promotional violations in magazine interviews. Do clinical investigators really sign away their right to free speech when they conduct a clinical trial for a drug company?

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS080639

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