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Jeffrey Stein, M.D.; Decision and Order

Uttam Dhillon, DEA Acting Administrator, issued a final order today in the case of the revocation of a New York doctor’s DEA registration. But its implications go well beyond this doctor’s circumstances.

The Facts

Here are the basics. Dr. Jeffrey Stein was convicted of tax-related crimes in the Southern District of New York in 2015. Specifically, Dr. Stein had provided false receipts and other fabricated documents to his accountant to reduce the amount of taxes he would have to pay and, in turn, to mislead the IRS Auditor into believing that the claimed expenses were legitimate. Dr. Stein pled guilty to these charges. Of particular relevance to today’s order, Dr. Stein had used, among the fabricated materials, “the names of four disabled military veterans (including two former patients whose identities he obtained as a result of his work for the V.A, [and] . . . created bogus invoices in the names of those veterans.”…

Continue Reading DEA Decisions: Registrations Not Automatically Revoked by Medicare/Medicaid Exclusions

As I have previously written, there is a long list of regulatory changes coming from DEA in the next few years.  Rather than publish one or more of the long overdue regulations listed on DEA’s Regulatory Agenda, on April 30, 2019, the agency will publish a Final Rule creating a “discretionary review” process allowing the Administrator to review an Administrative Law Judge’s (“ALJ’s”) denial of a request for an interlocutory appeal.  Note that this is a Final Rule, not a Notice of Proposed Rulemaking.  The agency was able to bypass the traditional notice and comment rulemaking process by categorizing this rule as a Rule of Agency, pursuant to the Administrative Procedure Act.  As such, the rule is effective immediately.

Requests for interlocutory appeals can take many forms in a DEA administrative proceeding.  Often, they are a result of a procedural or evidentiary ruling by an ALJ during the prehearing process.  DEA regulations currently give ALJs broad authority to rule on a request to seek an interlocutory appeal.  The ALJ’s decision to deny a request for an interlocutory appeal is not reviewable.  Until now.…

Continue Reading Does the New Rule on Interlocutory Appeals Undermine the Independence of DEA’s ALJs?

The Department of Justice recently published its list of proposed regulatory actions for the near and long term.  It appears that the Drug Enforcement Administration’s (DEA’s) Regulatory Drafting and Support Section is going to have a busy year.  The Unified Agenda indicates several potential regulatory changes are in store for the coming year, some of which may have significant impact on the regulated community.

A few highlights:

  • Updates to the suspicious order regulation have been delayed to at least February 2019.
  • DEA will provide guidance for Emergency Medical Services wishing to handle controlled substances.
  • After more than nine years, DEA is finally implementing regulations regarding the practice of telemedicine, as required by Congress in the Ryan Haight Act.
  • Guidance is forthcoming regarding the partial filling of prescriptions for Schedule II controlled substances as a result of related provisions in the Comprehensive Addiction and Recovery Act (CARA) of 2016.
  • It appears that additional (and significant changes) will be coming to DEA’s quota process.
  • DEA is getting rid of the carbon copy 222 form! (for those too young to understand the concept of carbon copies, click here)

Below are links to each notification and a summary taken directly from the related Abstract.

Stay tuned. We will provide updates as they become available.…

Continue Reading DEA to Propose Significant Regulatory Changes in the Coming Year

A United States District Court Judge issued a temporary restraining order prohibiting the Drug Enforcement Administration (DEA) from enforcing the Immediate Suspension Order issued against Morris & Dickson.

Acknowledging, that the entire administrative record was not before the court, Judge Foote nonetheless held that “Plaintiff has demonstrated a substantial likelihood that it will be able…

While a great deal of attention is given to DEA Chief Administrative Law Judge Mulrooney’s (“CALJ Mulrooney’s”) opinion regarding the impact of the Ensuring Patient Access and Effective Drug Enforcement Act on DEA enforcement efforts, very little attention has been afforded a shocking and unprecedented attack by a sitting DEA Administrative Law Judge on DEA’s formal administrative hearing process found within the same article.

Hidden in plain sight at the end of CALJ Mulrooney’s and Ms. Katherine Legel’s soon-to-be-published law review article is a thirty page attack on the procedures that govern DEA administrative hearings, substantive decisions in final agency decisions, and the individuals assigned to draft final agency decisions on behalf of the agency.…
Continue Reading Are DEA Administrative Hearings Fundamentally Unfair to Registrants?

Dear President Trump,

For several years the prescription drug epidemic has ravaged communities across the United States. During that time, the Drug Enforcement Administration (“DEA”) has aggressively pursued enforcement actions against the regulated industry. Despite admirable efforts to curtail the epidemic through enforcement actions, prescription drug abuse continues to be a public health crisis. There have been many solutions put forth in the past several months. These solutions, while well-intended, failed to address the root causes of the epidemic – overprescribing of controlled substances. Mr. President, this is a unique opportunity for you to reset our approach to this crisis. As a first step, we need to reassess the enforcement-first approach of the past several years.
Continue Reading An “Open Letter” to President Trump Regarding the Prescription Drug Abuse Epidemic

On June 30, 2017, the Court of Appeals for the D.C. Circuit issued an order in Masters Pharmaceutical, Inc. v. Drug Enforcement Administration (No. 15-1335). In sum, the Court denied Masters Pharmaceutical, Inc.’s (“Masters”) Petition for Review seeking to overturn the Drug Enforcement Administration’s (“DEA”) revocation of Masters’ DEA registration. This decision has wide-ranging implications for DEA-registered wholesalers, who are required to detect and report suspicious orders of controlled substances.
Continue Reading DEA Prevails Over Masters Pharmaceutical, Inc.

Marijuana is less dangerous than some substances in other schedules, but it will stay in Schedule I for now, DEA said Thursday. The agency also said that it supports marijuana research, is developing an online application system to apply for Schedule I research registrations, and will allow more manufacturers to grow marijuana for research.…

Pills production Line

On May 11, 2016, the Drug Enforcement Administration filed its brief in Masters Pharmaceutical, Inc. v. Drug Enforcement Administration (Docket No: 15-1335), in the United States Court of Appeals for the District of Columbia. The vast majority of the Government’s brief addresses whether “substantial evidence” (the applicable standard of review) supports Acting Administrator Rosenberg’s decision to revoke Masters’ DEA registration. Curiously, the Government does not dedicate much effort to one of the seminal issues in the case: whether DEA imposed new obligations on registrants in violation of the Administrative Procedure Act.

Rather than attempt to defend the indefensible, the Government invoked a creative reading of the Masters Final Order that is starkly at odds with Administrator Rosenberg’s decision. In its brief, DEA states that Administrator Rosenberg’s decision “did not impose any new duties on distributors.” In defending this position, the Government’s brief goes on to say the following:

Most of the “new duties” that Masters and amici cite in their briefs were obligations that Masters had voluntarily imposed on itself through its own compliance program. [citation omitted] The Administrator cited Masters’ failure to perform many of these duties – such as obtaining utilization reports or asking customers for explanations of unusually large orders – because Masters sought to rely on its compliance program to justify its reporting failures. However, in highlighting Masters’ disregard for its own program’s requirements, the Administrator did not impose those same requirements on all registered distributors.

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Continue Reading The Continued Evolution of DEA’s Due Diligence Requirements

drugs

On September 23, 2014, DEA announced that its ninth Take Back Day would be the agency’s last.  The announcement was made shortly after DEA published the Final Rule implementing the Secure and Responsible Drug Disposal Act of 2010.  The regulations promulgated by DEA allow “authorized collectors” the opportunity to receive and securely dispose of prescription…