17x Return on DOJ Fraud
Fraud and abuse has been a hot topic for Congressional oversight, and the DOJ is performing admirably by stockpiling revenues -- $2.5B in FY2010 alone for civil healthcare fraud with $1.6MM courtesy of...
View ArticleSmall No Longer Means Safe: What You Need to Know
Today, the Wilson Sonsini Goodrich & Rosati (WSGR) Life Sciences Report for Spring 2011 was published. Here are the GPP highlights: Key Observation #1: "While many of the more prominent fraud and...
View ArticleKeeping Companies Out of Trouble
I am at the Dow Jones Global Compliance Symposium today (www.gcs.dowjones.com). I will recap major sessions here. In response to, "What are you doing to keep your company out of trouble?", here are...
View ArticleJailing Individuals: What's Next in Fraud and FCPA
Three things you need to know about the new trend to jail individuals for fraud and FCPA violations: 1. Individuals are already being prosecuted at up to 400 times the rate of companies. Key support...
View ArticleWho's Afraid of the DOJ?
I was very much looking forward to hearing Lanny Breuer, Assistant Attorney General for the Criminal Division, U.S. Department of Justice, speak this morning at the Dow Jones Global Compliance...
View ArticlePatient's View on Actimmune CEO Sentence
As CEO of biotechnology company InterMune, Harkonen published an outright lie, claiming that this drug “reduces mortality by 70% in patients with mild to moderate disease.” He did this after a Phase II...
View Article3 Risk-Benefit Tips for DTC Websites from FDA Studies
Just recently, the FDA gave us a hint of how they are currently thinking about fair balance and risk information when using websites to advertise. On April 28, 2011, the FDA proposed and requested...
View ArticleMedical Devices: The New Low-Hanging Fruit for Healthcare Fraud?
Learn what the FDA and U.S. Attorney's offices from several different states discussed about the government's views and priorities on liability and enforcement in off-label cases and other compliance...
View ArticleNew Lawsuit Chips Away at FDA’s Unwritten Off-Label Rules
Par Pharmaceutical, Inc. filed suit on October 14, 2011 to curtail prosecutions for off-label promotion based solely upon the physician specialties to which pharmaceutical manufacturers market their...
View ArticleAttacks on FDA’s Aggressive Stance: Off vs. On-Label
Many manufacturers and industry watchers have recently renewed their challenges to the constitutionality of FDA’s expansive interpretation of off-label promotion on First Amendment grounds. Par...
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