Life Science Compliance Update

September

2018

Catching A Glimpse – A Unique Look at Sanofi MS Subpoena For Potential AKS Violations

Written by , Posted in Uncategorized

By Carolyn Greene, Esq.

In response to media reports of sensational drug prices, the DOJ has launched investigations into marketing practices, issuing subpoenas to many pharmaceutical companies. Sanofi reported that it was recently subpoenaed about its marketing practices as to two of its MS drugs, Lemtrada and Aubagio. In an unfortunate turn of events for Sanofi, someone leaked Sanofi’s Legal Hold notice written in response to the DOJ subpoena. The Legal Hold notice provides unique insight into the types of marketing practices that the DOJ is investigating, including strategies relating to patient charities, PAPs and other areas where healthcare providers receive some kind of remuneration.


   or   

  • Return to September 2018 LSC Update Table of Contents
  • Copy abstract URL
  • Order Reprints
  • Topic tags:

    May

    2018

    Open Payments & Kickbacks: Are Indicted Physicians on Your Company’s Payroll?

    Written by , Posted in Uncategorized

    Nicodemo Fiorentino, Esq.

    This article uses Open Payments data from the government’s publicly available database to provide a different way of reading the U.S. Government’s recent unsealing of a criminal indictment. The indictment alleges five (5) New York licensed physicians violated, among other laws, the Federal Anti-Kickback Statute for their participation in accepting speaker program fees and other payments in return for prescribing a fentanyl product indicated for the management of breakthrough pain in cancer patients. Additionally, the Government provides evidence that the pharmaceutical company lacked the ability to ensure compliance with U.S. fraud and abuse laws. Compliance and legal departments will want to carefully review the indictment and watch the case closely. It may turn out to be a test case for the Centers for Medicare & Medicaid Services to finally enforce the Physician Payments Sunshine Act and implementing regulations.


       or   


    Menu Title