The Drug Enforcement Administration (DEA), through a Notice of Proposed Rulemaking (NPRM), is seeking to make significant changes to its administrative hearing procedures. The proposed changes include the following, among others:

  • Requiring registrants to submit a request for hearing no later than fifteen (15) days after service of an Order to Show Cause (OSC). Under current regulations, registrants have thirty (30) days in which to request a hearing.
  • Requiring registrants to file a formal response addressing each factual allegation in the OSC within thirty (30) days of service of the OSC. Respondents are required to admit or deny each factual allegation in the OSC. There are currently no provisions in the regulations requiring respondents to file what is akin to an answer in civil proceedings.
  • Establishing default rules whereby proceedings shall be terminated and the factual allegations in the OSC shall be deemed admitted where the registrant fails to file a request for hearing, fails to file an answer to the OSC, or fails to otherwise participate in the administrative proceedings.
  • Removing provisions in the regulations allowing for registrants to submit a factual and legal response to the OSC in lieu of administrative hearings.

DEA indicates that one justification for changing its regulations is to bring DEA in line with the “hearing regulations of many other Federal agencies.” In addition to conserving “scarce agency resources,” DEA also insists that “the proposed rulemaking will speed the disposition of cases[.]”

Establishing default rules for instances where registrants are not participating in the administrative hearing process is long overdue. From my experience, a lot of unnecessary time and energy is expended on these cases. Perhaps the shortened deadline for filing a hearing request and the subsequent requirement for filing an answer may also lead to greater efficiencies in the administrative process. What these changes do not do, however, is speed the disposition of cases.

Since his appointment, Chief Administrative Law Judge John J. Mulrooney II has implemented internal procedures and controls to minimize delay in administrative hearings.  Where administrative hearings would take several years, they are now typically concluded within a year or less of issuance of the OSC. The delay in disposition of cases usually occurs after the administrative hearings have concluded. Two recent cases are instructive.

In August 2016, an OSC was issued against Heavenly Care Pharmacy. The Administrative Law Judge’s (ALJ’s) decision was issued and subsequently forwarded to the Administrator in November 2017.  The Administrator issued a Final Order at the end of August 2020, nearly three years after the administrative hearings had concluded.

Similarly, in June 2017, DEA issued an OSC seeking to deny an application for registration submitted by Dr. Hamada Makaritaon. In February 2018, shortly after the one-day hearing, the ALJ forwarded the matter for issuance of a Final Order. It was not until July 2020, that an order denying the application was issued by the Acting Administrator.

As DEA notes in the NPRM, many of the regulations involving administrative hearings have been in place since 1971. While the proposed changes are a good start, what is still lacking are internal controls or regulatory provisions imposing deadlines on the issuance of a Final Order after the administrative hearings before an ALJ have concluded. That appears to be where much of the delay continues to reside in timely disposing of administrative cases before DEA.

Comments on the NPRM must be submitted within 60 days of publication of the NPRM in the Federal Register.