A Fortune 500 Pharma company is looking for a Senior Director of Compliance who will report to the Chief Compliance Officer and will assist in developing, implementing and executing the company’s corporate compliance program.
A recent article Jeanne Whallen at the Wall Street Journal highlights a line of thinking that many pharma companies, like AstroZeneca, are coming around to these days: we must be vigilant about ensuring that our drugs are promoted ethically.
Pharmaceutical companies are under an increasingly focused spotlight as the government continues to crack down on marketing and promotion practices. The crackdown has led to many high profile (and high dollar) settlements that have pharma companies across the country scrambling to refocus and reform their compliance programs. And, naturally, opportunistic software developers have swooped in to capitalize.
A recent program sponsored by the Seton Hall Law Center for Health and Pharmaceutical Law & Policy urged health care and life sciences companies to place a high degree of emphasis on developing and maintaining effective corporate compliance programs.
Scott Bruns and Kathleen Meriwether of Ernst & Young count down the top five compliance risks facing life sciences companies, including sales & marketing risks, the FCPA and IFRS, as well as supply-chain integrity and aggregate spend.
By Joel Hesch, Liberty University
The government has honed in on three primary areas where it alleges that a pharmaceutical company commits fraud. In addition, there is an emerging new area, adulterated products, where the DOJ is beginning to investigate and just may be the next huge compliance risk.
By Navigant Consulting
Recent Corporate Integrity Agreements (CIAs) from the Office of Inspector General of the Department of Health and Human Services (OIG) have included unique obligations requiring Board of Directors and Senior Management to be held accountable for compliance, while increasing the scope and sophistication of reviews performed by Independent Review Organizations (IROs). These emerging CIA trends are most evident in recent pharmaceutical and medical device company settlements.
We consider the evolving requirements of the OIG and propose actions that can be implemented to maintain a Compliance Program that meets or exceeds current OIG requirements.
This past week, Pfizer announced that it would pay a $1.2 billion criminal fine as part of a $2.3 billion settlement involving illegal off-label drug promotion. The facts of the Pfizer case will be closely studied by pharma compliance personnel for various lessons learned specific to the industry, but there are also general compliance lessons to be learned.
by Hein Smit Sibinga and Wade Speir of PA Consulting Group
The new PhRMA and AdvaMed Codes of Ethics on Interactions with Health Care Professionals have received a great deal of attention, focused on the particulars of the various rules which will, no doubt, be interpreted by industry and in the courts for years to come. However, a crucial passage in the AdvaMed code, which “encourages” companies to follow the seven elements of an appropriately tailored, effective compliance program has not received due attention. It focuses on the importance of building the crucial governance required to be able to comply in an effective and efficient manner – a lesson still being learned in many others areas of the pharmaceutical business.
In today’s edition of the GRC news roundup, we look at the CFTC review being faced by Goldman Sachs and Morgan Stanley as well as the antitrust probe facing Teva and Servier.
