A Murky Future for Off-label Promotion: New Leadership at the FDA Brings Change

On May 11, 2017, Dr. Scott Gottlieb was sworn in as the U.S. Food and Drug Administration’s latest Commissioner. Since that time, there has already been various regulatory changes and shifts, in terms of policy guidance, as well as a new focus toward easing the Agency’s rules and regulations pertaining to off-label uses. The article will explore those changes and the Agency continues to refine the “intended use” rules.

The U.S. Food and Drug Administration’s (“FDA”) Twenty-Third Commissioner, Dr. Gottlieb, is a man of many talents. He is a physician, medical policy expert, and public health advocate. As a practicing physician, he was previously a Resident Fellow at the American Enterprise Institute, and a Clinical Assistant Professor at the New York University School of Medicine in Manhattan, where he also practiced medicine. Dr. Gottlieb also has deep FDA experience, having previously served as the FDA’s Deputy Commissioner for Medical and Scientific Affairs and as a senior advisor to the FDA Commissioner.