Device PMA Advisory Meetings Disappearing: Attorneys

Attorneys Jeffrey Gibbs and McKenzie Cato (Hyman, Phelps & McNamara) document the slow disappearance of advisory panel meetings for PMA applications. Writing in their firm’s FDA Law Blog, the two say there were nine panel meetings in 2010, two in 2019, and none last year.

They say the panel process “provided otherwise inaccessible insights into FDA’s thinking, as well as the ability to analyze the impact of policy changes on substantive decisions.”

Gibbs and Cato point out that FDA did hold nine other panel meetings in 2019 and does still convene panels to consider applications for new molecular entities. But, with the number of advisory panel meetings for drugs also dropping significantly in recent years, they conclude that if the trends continue, committee meetings to review individual product applications “may eventually become extinct.”