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: Continue Reading 2019 National Drug Threat Assessment: Key Takeaways

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. Continue Reading DEA Signals that Substantive SOM Guidance is Not Likely Forthcoming

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.

Suspicious Orders

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. Continue Reading What to Expect from DEA in 2020 – One Guy’s Opinion

DEA is investigating two pharmacies in Colorado. It doesn’t want those pharmacies to know it is investigating them. But it needs information relating to these pharmacies and the prescriptions they are dispensing to assist with its investigation. So DEA is doing what it does on a regular basis in many states. It is issuing subpoenas for the Colorado Prescription Drug Monitoring Program (“PDMP”) data relevant to these registrants. And Colorado is objecting.

Continue Reading The Curious Case of Colorado: DEA Sues the BOP

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. Continue Reading Judge Dissolves ISO Against West Virginia Pharmacy: Suspicion Of Diversion Not Enough to Support Suspension

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:

  • Distributors
  • Manufacturers
  • Importers
  • Pharmacies
  • Hospitals/Clinics
  • Teaching Institutions
  • Practitioners
  • Mid-Level Practitioners
  • Mid-Level Practitioners – Ambulance Services
  • Researchers
  • Analytical Labs
  • Narcotic Treatment Programs (NTPs)

Reverse distributors and exporters are excluded from the requirement. Continue Reading DEA Announces its New Suspicious Orders Report System Online: the devil is in the details we don’t yet have

If you are looking to stay informed on legal issues as they pertain to pharmacy, pharmaceuticals and related products and services, there’s still time to register for the American Society for Pharmacy Law Fall Meeting. You’ll learn from industry experts on topics critical to managing the legal risk and compliance inherent in pharmacy operations while earning up to 15 hours of continuing legal and pharmacy education credits.

Having attended and presented multiple times and now as a sponsor, I can tell you that this is the must-attend industry conference for pharmacy law.

2019 ASPL Fall Meeting
Developments in Pharmacy Law Seminar XXX
November 7-10, 2019
Westin San Diego Gaslamp Quarter San Diego, California

I will be co-presenting with Kimberly Frazier from Walmart, covering the topic of “Dispensing Controlled Substances: Navigating a Minefield of Contradictions.” We will be providing an overview of the current enforcement and litigation landscape and will address the various minefields that pharmacists must traverse when dispensing controlled substances. Keynote speaker Carmen Catizone, Executive Director National Association of Boards of Pharmacy, will share his thoughts on the future of pharmacy regulation. Other conference topics include ethics, telepharmacy, online pharmacies, CPB and cannabis, employment law, patient safety, drug pricing reform, privacy, litigation enforcement, attorney-client privilege and more.

For more information and registration, visit www.aspl.org.

Hope to see you there!

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. Continue Reading Problems Identified, Solutions Proposed: the OIG Review of DEA

While acknowledging the safety of the approved daily doses of OTC loperamide for adults (8mg per day) and prescription loperamide (16mg per day), the FDA recently approved new package-size and package-type limits for the brand-name OTC tablet and capsule forms of the drug. Here are the products affected by the FDA’s notice:

  • Imodium A-D
  • Imodium Multi-Symptom Relief
  • Be Health Loperamide HCl Capsules

Loperamide has been referred to as the “poor man’s methadone,” due to effects of abusing the drug via high doses. This has led to reports of “serious heart problems and deaths associated with loperamide,” with “the majority” relating to abuse and misuse of the drug.

The FDA’s action limits the package sizes by “limiting each carton to no more than 48mg” (24 tablets or a 6-day supply at maximum approved use) and provides for unit-dose packaging for the affected products, which the FDA believes “may reduce medication overdose and death.”

The FDA also requested that “online distributors take voluntary steps to help reduce the risks of loperamide abuse and misuse by not selling more than one package of these drugs to each customer.”

Finally, the FDA announced that it “is also taking steps to make sure that consumers can easily access and read the product labeling and warnings for drugs sold on shelves or on websites before purchase.” These efforts relate to generic manufacturers and liquid loperamide products as well. This is a continuation of a 2018 FDA request.

 

 

 

Image by Petra Göschel from Pixabay

Quota Reductions

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.”

Continue Reading DEA Proposes Decreasing Opioid Quotas for 2020