FCPA TEVA – Using Legitimate Distributor Payments to Conceal Bribes Thomas Sullivan Apr 24, 2017 0 On December 22, 2016, the Securities and Exchange Commission (SEC) announced that Teva Pharmaceutical Industries Limited had…
Compliance Eighth Aggregate Spend and Sunshine Act Conference Thomas Sullivan Apr 24, 2017 0 On June 15th and 16th, 2017, the Eighth Aggregate Spend and Sunshine Act Conference will be held at the Sonesta Philadelphia…
Editorials Dr. Stossel Corrects a Common Misconception Thomas Sullivan Apr 21, 2017 0 Thomas P. Stossel, MD, MD (Hon), is a visiting scholar at the American Enterprise Institute and professor emeritus at Harvard…
False Claims Act Going Back to the Roots of the False Claims Act – Baxter Settles cGMP… Thomas Sullivan Apr 21, 2017 0 While False Claims Act cases are relatively common in the life science industry, FCA cases for cGMP violations are not. This…
Drug Shortages FDA Under Pressure to Speed Up Generic Approvals Thomas Sullivan Apr 20, 2017 0 As has been reported, the FDA is under pressure to speed up approval of generic medicines. In response, the FDA released data…
Events FDA Public Workshop on Opioid Training Thomas Sullivan Apr 20, 2017 0 The Food and Drug Administration (FDA) has announced a public workshop to obtain input on issues and challenges associated with…
Opioids New Documentary on Difficulties Faced by Patients With Chronic Pain Thomas Sullivan Apr 19, 2017 0 Dr. Lynn Webster of Utah recently produced a documentary about pain treatment. The documentary, “The Painful Truth,” can be found…
HHS-OIG Project Exclusion: The OIG’s Latest Attempt to Make Its Exclusion Authority… Thomas Sullivan Apr 19, 2017 0 On January 11, 2017, the Office of Inspector General (OIG) at the U.S. Department of Health and Human Services (HHS), issued a new…
FDA Will There Be an Uptick in FDA NDA Approvals This Year? Thomas Sullivan Apr 18, 2017 0 Late last year, John Jenkins, director of the FDA’s Office of New Drugs told attendees at an event that the decline in new drug…
Drug Prices Maryland Sends Bill to Governor on Drug Prices Thomas Sullivan Apr 17, 2017 0 The Maryland House recently passed a bill – House Bill 631 – with the goal of “prohibiting a manufacturer or wholesale distributor…