It was a somewhat unsettling year for the Drug Enforcement Administration. The Agency faced a barrage of criticism in the press regarding its involvement in passage of the Ensuring Patient Access and Effective Drug Enforcement Act (EPAEDEA), which some criticized as hobbling DEA’s immediate suspension order (ISO) authority (see here). Meanwhile, notwithstanding a D.C. Circuit “win” for the Agency in Masters Pharmaceutical, Inc. v. Drug Enforcement Administration, 861 F.3d 206 (D.C. Cir. 2017), where the court set forth new and significant suspicious order monitoring and reporting requirements, the industry still decried the lack of clarification to DEA’s suspicious order reporting regulations—promulgated by notice-and-comment rulemaking—something the Agency has been promising for years (see post here).
Regardless, DEA’s Diversion Control Division has continued to bring administrative revocation and registration denial cases (see post here for a general description) against DEA registrants (typically practitioner cases). According to DEA, the number of administrative cases brought in 2017 was more than double the number brought in 2014.
Based on our review of the published decisions this year, here are some statistics on DEA’s 2017 administrative docket:
- 46: Number of new final orders (up from 28 in 2016)
- 44: Number of new final orders adjudicating individual (e.g., doctor, dentist, veterinarian) registrations (a pharmacy and a clinic made up the remaining two final orders)
- 1: Number of ISO cases
- 29: Number of cases based solely on loss of state authority (see post here) (up from 15 in 2016)
- 17: Number of cases where the respondent made a timely request for a hearing (i.e., before an ALJ)
- 13: Number of cases with a timely request for a hearing that were decided on summary disposition (i.e., without a hearing)
- 3: Number of cases where the Administrator rejected the presiding ALJ’s recommended decision
- 0: Number of corrective action plans that DEA has accepted (see DEA statement here)
It is important to note that these statistics do not take into account administrative actions where a party surrendered a registration prior to DEA initiating proceedings or cases that DEA and the registrant settled without going to a hearing.
Our readers know that we closely follow DEA’s administrative decisions, and we are committed to keeping you up to date on significant developments in these decisions. Here are some of the highlights of our posts from 2017:
- DEA’s concerning and questionable expanded use of summary disposition to decide cases other than those solely based on a loss of state authority (see posts here and here)
- DEA’s use of official notice (see post here)
- DEA’s finding that the two key elements of a valid prescription contained in 21 C.F.R. § 1306.04(a)—(1) issued for a legitimate medical purpose (2) by an individual practitioner acting in the usual course of professional practice—have no material difference (see post here)
- A new set of requirements (not contained in the regulations) that require practitioners to investigate whether their registrations are being misused for diversion (see post here)
As we embark on a new year, we will continue to keep you posted on new decisions as they are published.