Direct Final Rulemaking in the FDA: Lessons from the First Decade

Abstract

In an effort to improve efficiency, several administrative agencies, including the Food and Drug Administration, have adopted a procedure known as direct final rulemaking (DFR). Some academics have debated whether DFR violates the Administrative Procedure Act, but none have studied how DFR has functioned in practice. This paper, which examines the first decade of DFR at the FDA, is the first of this kind. The results are surprising, and suggest DFR deserves more study than it has received. Intended for noncontroversial rules that are expected to receive no significant comments in a notice-and-comment rulemaking, FDA has often used direct final rulemaking for the opposite: regulations that may be expected to be controversial. Far from generating few comments, forty percent of DFRs have had to be withdrawn due to significant opposition. These findings suggest greater limits be placed on the use of direct final rulemaking and that its legality be re-evaluated in light of how the procedure is actually used.