This article, by Kenneth Yood and Christine Cohn of Sheppard Mullin, presents a summary of some of the key features in Senator Baucus’ health care bill that are particularly relevant to the drug industry and that merit close attention.
News is breaking today that the United States government has slapped a suit against Johnson & Johnson and two of its subsidiaries for allegedly paying kickbacks to nursing homes in an effort to boost sale for a new antipsychotic drug.
This is the first of a three part series on building a compliance program by Chris Cobourn and Clarissa Crain of CIS. In Part I, the authors discuss four key steps in developing a risk profile and risk management 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.
Reporting to the Deputy General Counsel, the In-House Counsel will be responsible for providing counsel on all matters related to the development and approval of all advertising, promotional and training materials related to product promotion.
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.
