Medico-Legal Ethics of Off-Label Use of Pharmaceuticals and Devices

May 8, 2012

NCHCA Meeting
Franklin, Tennessee

Bass, Berry & Sims healthcare attorneys John Kelly and Danielle Sloane will present the topic “Medico-Legal Ethics of Off-Label Use of Pharmaceuticals and Devices,” at an upcoming Nashville Council of Health Care Attorneys (NCHCA) meeting. This presentation will include:

  • Overview of what constitutes off label use versus off label promotion and why physicians prescribe off-label;
  • Government recent enforcement of off-label promotion violations;
  • The pharmaceutical and device companies attempting to limit the FDA’s reach with the first amendment;
  • FDA response to industry requests for additional clarity on when it is permissible for pharmaceutical and device companies to distribute information regarding off-label uses; and
  • An ethical debate and evaluation of competing interests: regulatory oversight versus off-label promotion and use.

This course has been approved for one hour of dual CLE credit.