On Monday, May 2, 2016, Washington Legal Foundation hosted a program in its Media Briefing series entitled Freeing Off-Label Use Information: Three Lingering Questions for Medical-Product Innovators and Regulators. The recording of that program is available below. Also below are links to related materials, including an April 29, 2016 WLF Legal Backgrounder that draws lessons from a medical-device company’s successful defense of a criminal prosecution for alleged off-label promotion.

Participants:

  • Edward Berg, Sanofi US
  • John Osborn, Hogan Lovells LLP
  • Coleen Klasmeier, Sidley Austin LLP
  • Eric Grannon, White & Case LLP (moderator)

The program can also be viewed through WLF’s website—with a higher-quality video and integrated slides—by clicking here.

John Osborn’s Yale Journal article, “Can I Tell You the Truth?”, cited by the U.S. Court of Appeals for the Second Circuit in U.S. v. Caronia, is available here.

WLF’s Legal Backgrounder, “The US v. Vascular Solutions Acquittal: Three Lessons for Targets of ‘Off-Label Promotion’ Enforcement,” is available here.