No Fault? Not Quite
This article was originally published in RPM Report
An HHS departmental appeals board decision finds Purdue executives at fault despite plea and convictions based solely on the Dotterweich and Park doctrines
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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.
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.
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?