PMA panel votes: More than meets the eye

August 20, 2019By: Jeffrey N. Gibbs & McKenzie E. Cato Download PDF

FDA advisory panels meetings to review pre-market applications (PMAs) are high-stakes events. While FDA is not bound by the vote of the advisory panel, it has been long-accepted that the agency typically follows the recommendation of the panel.

Which got us thinking: are conventional wisdom and the data on PMA advisory decisions consistent?  We previously looked at advisory panel data to see whether some seemingly minor procedural changes in panel voting had affected voting patterns.  The data suggested that these changes had had an effect, but not in the way most people would have predicted.

Thus we decided to take a closer look at the relationship between panel votes and the ultimate outcomes and time to resolution of PMAs.  Once again, the results were not what might have been expected.

Related Professionals