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 30, 2020, the Drug Enforcement Administration (DEA) released the 2019 National Drug Threat Assessment (NDTA). The 152-page publication “outlines the threats posed to the United States by domestic and international drug trafficking and the abuse of illicit drugs.” Of specific relevance to readers of DEA Chronicles, the report also discusses the abuse and misuse of controlled prescription drugs (CPDs). While I encourage you to read the entire report, here are a few key takeaways regarding CPDs:…
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.…
DEA is out with its proposed 2020 aggregate production quotas for Schedule I and II controlled substances, and they have been reduced dramatically from 2019’s numbers. From the press release:
DEA proposes to reduce the amount of fentanyl produced by 31 percent, hydrocodone by 19 percent, hydromorphone by 25 percent, oxycodone by nine percent and oxymorphone by 55 percent. Combined with morphine, the proposed quota would be a 53 percent decrease in the amount of allowable production of these opioids since 2016.”
How’d They Get There?
Why the size of the decrease? Aside from the obvious political pressures attendant to legitimate concern over the proliferation of the opioid crisis and, perhaps, some less-legitimate political posturing, the DEA cites the usual factors and a significant new one. As always, DEA consults “many sources, including estimates of the legitimate medical need from the Food and Drug Administration; estimates of retail consumption based on prescriptions dispensed; manufacturer’s disposition history and forecasts; data from DEA’s internal system for tracking controlled substance transactions; and past quota histories.”
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…
In a joint statement by the U.S. Department of Justice and the Drug Enforcement Administration, the government announced continued efforts to tackle the opioid crisis by reducing the quantity of controlled substances permitted to be manufactured next year. The proposal decreases the 2019 Aggregate Production Quotas (APQ) for six of the most frequently misused…
On May 2, 2018, the DEA issued an Order to Show Cause and Immediate Suspension of Registration (the “Order”) against Morris & Dickson Co., LLC (“M&D”), a drug distributor based in Louisiana with pharmacy customers in 7 states. The DEA has two main allegations against M&D:
- M&D failed to maintain effective controls against division of controlled substances into other than legitimate channels, in violation of 21 USC 823(b)(1) and 21 CFR 1301.71.
- M&D failed to identify and report suspicious orders to DEA, in violation of 21 CFR 1301.74(b).