Rulemaking without Rules: An Empirical Study of Direct Final Rulemaking

ABSTRACT In an effort to improve efficiency, several administrative agencies have adopted a procedure known as "direct final rulemaking" (DFR). Some academics have debated whether DFR violates the Administrative Procedure Act (APA), but none have studied how DFR has functioned in practice. This paper, which examines the first decade of DFR at the Food and Drug Administration (FDA), is the first of this kind. The results are surprising, and suggest DFR deserves more attention than it has received. Intended for noncontroversial rules that are expected to receive no significant comments in a notice-and-comment rulemaking, the 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 Far from generating few comments, forty percent of DFRs have had to be withdrawn due to significant opposition.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 should be placed on the use of direct final rulemaking and that its legality be reevaluated in light of how the procedure is actually used. As it is presently practiced, direct final rulemaking could increase cynicism about government. INTRODUCTION Frustrated with the pace of even the most minor rulemaking, federal agencies have experimented with streamlined regulatory practices over the past several decades. (1) One such innovation, "direct final rulemaking," allows an agency to dispense with some amount of procedure for rules that it expects to be uncontroversial. (2) This paper is the first case study to evaluate the implications of direct final rulemaking in practice--an evaluation of direct final rulemaking by the FDA over the past decade. The FDA example raises real concerns about the value and wisdom of the innovation. The FDA has a remarkably poor record at predicting which of its regulations will truly be noncontroversial, and this study suggests that it has been classifying certain proposed regulations as "noncontroversial" in hopes, most frequently misplaced, that they will go unnoticed. Proponents of DFR argue that even if DFR is producing few efficiency gains, the possibility of such gains make DFR worthwhile because it is, at worst, harmless. (3) The experience of DFR at the FDA belies this view. Failed direct final rulemaking, as the practice at the FDA must be called, may reduce the efficiency of agency rulemaking, can cause confusion about the state of the currently effective law, and erodes public confidence in the rulemaking process. Under the model of American administrative rulemaking predominant since the late twentieth century, (4) the FDA--or any other agency--has a straightforward path for enacting a regulation: it publishes a notice of proposed rulemaking in the Federal Register, solicits comments on the rule for a fixed period of time, and then publishes a final rule in the Federal Register, incorporating responses to all significant comments. (5) Nowhere in notice-and-comment informal rulemaking does the agency make a determination about whether a rule will be controversial or not. Whether or not an agency receives adverse comments in the rulemaking, it may still proceed to publish a final rule, as long as the final rule adequately responds to the comments. (6) However, since 1997 the FDA has conducted abbreviated informal rulemaking, called "direct final rulemaking," which requires the agency to determine at the outset whether a rule is expected to be "noncontroversial" and thus unlikely to generate significant adverse comments. (7) If a rulemaking is expected to be noncontroversial, the FDA issues a proposed rule and a direct final rule on the same day. Both solicit comments, typically for a seventy-five-day comment period. If the FDA receives no significant adverse comments, as would be expected for a truly noncontroversial rule, then the direct final rule becomes effective, typically sixty days after the close of the comment period. If the agency receives even a single significant adverse comment, it withdraws the direct final rule, and--assuming it still wishes to promulgate the rule--issues a new final rule, on the basis of the comments and the proposed rule that was published the same day as the now-withdrawn direct final rule. …