DEA rolled out its proposed aggregate production quotas for 2021 earlier this week, the same day, in fact, that it proposed adjustments to its 2020 quotas. Let’s start off by looking at the Big Five, at least as far as the SUPPORT Act is concerned: fentanyl, oxycodone, hydrocodone, oxymorphone, and hydromorphone.
Theft and Loss Reporting
On July 29, 2020, the Drug Enforcement Administration (DEA) issued a Notice of Proposed Rulemaking (NPRM) related to the reporting of thefts or significant losses of controlled substances. Specifically, DEA proposes two changes to the reporting process:
On March 13, 2020, the Drug Enforcement Administration (DEA) issued a Notice of Proposed Rulemaking (NPRM) seeking to raise registration fees on all DEA registrants. The proposed fees represent a 21% increase over current fees for all registrant categories. DEA indicates that the increase will provide an additional $318 million for the Diversion Fee Account over the next three fiscal years.
As discussed here, the Controlled Substances Act requires that registration fees “shall be set at a level that ensures the recovery of the full costs of operating the various aspects of [the diversion control program].” 21 USC 886a(1)(C). DEA alleges in the NPRM that “[w]ithout an increase in registration fees, DEA will be unable to continue current operations” and will be unable to comply with the statutory mandate to recover all costs associated with managing the Diversion Control Program (DCP).
To support this doom and gloom prediction, DEA points to several reasons to justify the fee increase. They include, but are not limited to, the ongoing opioid crisis, the growing number of DEA registrants, a need for additional personnel at Headquarters and in Field Division Offices throughout the country, and additional requirements imposed by Congress in recent legislation.
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.
Note: The following is my best guess for what to expect in the coming year regarding controlled substance compliance obligations. I have relied on publicly available information, my experience and expertise with all things involving pharmaceutical controlled substance, and a Magic 8 Ball in creating the list below.
This is the year (I think) that DEA will publish a Notice of Proposed Rule Making (NPRM) updating 1301.74(b). While industry is anxiously awaiting the new regulations, I fear that many will be disappointed. My best guess is that the new regulations will be more about changing the process for reporting suspicious orders and less about guidance for industry on the metrics to use for detecting suspicious orders. This is in part because Congress recently codified the existing definition of suspicious orders that has been in DEA’s regulations for decades, which takes away a great deal of DEA’s interpretative authority and discretion. There is also an argument to be made that DEA would prefer suspicious order guidance and definitions to be vague, providing the agency significant enforcement discretion.
In a decision issued on October 30, Judge Joseph Goodwin of the Southern District of West Virginia dissolved an Order of Immediate Suspension of Registration (“ISO”) issued by DEA against Oak Hill Hometown Pharmacy, a West Virginia pharmacy. Without getting too far into the factual weeds of this case, I do think there are two or three critical takeaways related to both the adjudication of this matter and to DEA’s view of Subutex vs. Suboxone.
Is “Suspicious Order” about to be defined?
The recently-released DOJ OIG Review of the Drug Enforcement Administration’s Regulatory and Enforcement Efforts to Control the Diversion of Opioids has met with extensive media coverage focused on the sexier aspects of the story. What did DEA do or not do to stem the opioids crisis? What internal battles may have led DEA to drop the ball in some aspects of the response? These are important questions, but they have been well-covered.
Instead, we are going to focus on a handful of the nine recommendations (listed below) made by the IG and DEA’s and ODAG’s responses.
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 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.”