Compliance with and Enforcement of US Healthcare Laws image

2-18-13
Lectures and Panels
2012-2013
Wasserstein Hall, Milstein West A, Harvard Law School

There have been a number of prosecutions of life sciences companies under the Food, Drug, and Cosmetic Act and the qui tam whistleblower provisions of the False Claims Act. Allegations included things like unlawful promotion, failure to report safety data, and false price reporting practices. Some of these cases resulted in massive settlements--some in the billion-dollar range.

Understandably, compliance has become a top priority for life sciences companies, which typically have dedicated compliance programs in place with ever more sophisticated internal programs for educating employees, preventing wrongful conduct, detecting and deterring violations, and ensuring prompt remedial action.  

This panel discussion focused on how life science compliance efforts have evolved to face a variety of challenges. Panelists included some of the leading experts from the government, life sciences industry, private bar, and academia:   

  • Mary Riordan, Senior Counsel, Department of Health and Human Services, Office of the Inspector General (OIG)

  • James Sheehan, Chief Integrity Officer, NYC Human Resources Administration; Former Medicaid Inspector General for New York State  

  • Paul Kalb, Partner, Healthcare Practice head, Life Sciences Practice global coordinator, Sidley Austin   

  • Kathleen Boozang, Professor of Law, Seton Hall 

  • Moderator: Kris Curry, Vice President, Health Care Compliance, Pharmaceuticals Group, Johnson & Johnson

With support from the Oswald DeN. Cammann fund.

Watch the lecture here

Tags

biotechnology   fda   health care finance   judicial opinions   pharmaceuticals   regulation   research misconduct