Check out my commentary in Saturday’s (April 14th) Business Section of the Minneapolis Star Tribune.

First introduced into life sciences more than two decades ago as the result of a government settlement, compliance officers and compliance departments are now considered essential for pharmaceutical and medical device companies. Without them, life science companies stand little chance of successfully navigating and managing the legal and compliance risks inherent in this highly regulated industry. However, the life sciences industry is no longer dominated by large market cap companies.…

Biosimilars have a bright future and promise potentially significant health care cost savings, provided the regulatory, legal and commercial hurdles are removed. Recent activity by CVS and United Healthcare are promising signs that indeed the commercial barriers are starting to come down. However, it remains unclear whether the FDA will help on the regulatory front.   CLICK HERE TO DOWNLOAD A FREE COPY OF THE FULL ARTICLE.

The breadth of liability under the False Claims Act including Anti-Kickback Statute is a closely watched area.  Recently, the U.S District Court for the Eastern District of Missouri concluded that liability might extend to a health care provider even where the plaintiff fails to demonstrate that the “primary purpose” of providing the benefits was to create an inducement. Although the impact of such Court case remains somewhat uncertain, it is…

This is Not Your Parent’s Compliance Program – The New Era of Compliance Resourcing at Small to Mid-Size Pharmaceutical Companies Patrik Florencio, Esq., Steven Franchetti, Seth Whitelaw, J.D., LL.M., S.J.D. At the 14th Annual CBI Pharmaceutical Compliance Congress held in April 2017, almost half the attendees were from small to mid-sized companies that generate $3 billion or less in annual revenue. At the same time, the compliance burdens for all…