As you are likely aware, the Drug Enforcement Administration (DEA) has created a COVID-19 Information Page to “assure that there is an adequate supply of controlled substances” during the current public health emergency associated with the coronavirus. DEA previously published guidance regarding telemedicine and Medication Assisted Treatment, where the agency granted certain exceptions to regulatory
It appears that the Drug Enforcement Administration (DEA) is on the cusp of publishing a new regulation in the next few weeks, with two more to follow in the coming months. This is based on notifications received by the Office of Management and Budget (OMB), the government’s final review authority for Executive Branch regulations.
On January 20, 2020, the Government Accountability Office (GAO) released its report Drug Control: Actions Needed to Ensure Usefulness of Data on Suspicious Opioid Orders. The report, mandated by Congress in the SUPPORT Act, focuses almost exclusively on the need for the Drug Enforcement Administration (DEA) to beef up its capabilities for analyzing the vast amount of data provided to DEA by registrants. GAO’s investigation revealed, among other things, that DEA conducted “limited proactive and robust analysis of industry reported data” and that DEA did not have the appropriate data governance structure in place to manage drug transaction data.…
On October 23, 2019, the Drug Enforcement Administration (DEA) announced the launch of its Suspicious Orders Report System (SORS) Online, a portal allowing for the centralized reporting of suspicious orders, as required by the SUPPORT ACT.
According to DEA’s announcement, 12 registrant business activity classes will utilize this reporting system:
- Teaching Institutions
- Mid-Level Practitioners
- Mid-Level Practitioners – Ambulance Services
- Analytical Labs
- Narcotic Treatment Programs (NTPs)
Reverse distributors and exporters are excluded from the requirement.…
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.
As you undoubtedly should know by now, on April 22, 2019, the United States Attorney for the Southern District of New York entered into a Deferred Prosecution Agreement (the “Agreement”) with the Rochester Drug Co-operative, Inc. (“RDC”).
Specifically, the government announced that
“RDC agreed to accept responsibility for its conduct by making admissions and stipulating to the accuracy of an extensive Statement of Facts, pay a $20 million penalty, reform and enhance its Controlled Substances Act compliance program, and submit to supervision by an independent monitor.”
As required by the “SUPPORT for Patients and Communities Act” (Public Law 115-217), DEA just announced that it has implemented a new tool to provide drug manufacturers and distributors with access to anonymized ARCOS information.
This an enhancement to DEA’s existing tool that previously provided very limited ARCOS information. The new functionality in the tool…
On February 21, 2019, the Drug Enforcement Administration (DEA) published a Notice of Proposed Rulemaking (NPRM), New Single-Sheet Format for U.S. Official Order Form for Schedule I and II Controlled Substances (DEA Form 222). This is the agency’s second attempt at bringing the DEA Form 222 into the 21st Century. In 2007, the agency issued a similar NPRM, but never published a Final Rule.
The current NPRM not only changes the format of the 222, but also proposes “minor procedural changes.” Below is a summary of some of those changes.
After a brief hiatus, DEA Chronicles is back. As always, I will be keeping you informed on changes in the relevant laws and regulations and how these may impact your business. But, as regular readers know, we go beyond simple reporting. DEA Chronicles identifies DEA enforcement trends. We engage in policy analysis across the spectrum of issues involving controlled substances. What regulatory approaches best combine an effective strategy for combating diversion with a workable framework for the various actors in the pharmaceutical industry? What are the best practices designed to ensure compliance? What are the red flags that should alert companies to potential problems within their organizations? We explore these and all other questions regarding the enforcement of controlled substance laws and regulations.
So why the hiatus? The answer is simple and, for me at least, kind of exciting. After six and a half years with Quarles & Brady, I am pleased to announce that I have moved the DEA Litigation and Compliance practice to my new firm, Cote Law PLLC. I bring to my DEA practice a unique set of experience and skills. For one, I worked at DEA at a management level in the enforcement area. I know my way around the agency. I know how it operates and how it thinks. It is one thing to read a statute or a regulation. It is another to understand how the people at the agency approach the enforcement of these laws.
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.