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.