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.
This is more of a wish than an expectation of what may be coming in 2020. By far the most common complaint I hear from clients surrounds DEA’s management of the CSOS program. From wait times when calling the help line that are measured in hours and not minutes to similar temporal challenges when seeking to renew CSOS certificates, this program needs a drastic facelift. For years, DEA has encouraged registrants to sign up for CSOS as the more secure alternative to ordering Schedule II controlled substances. It is time that DEA directs some of the substantial resources it collects from DEA registrants to bring the CSOS system into the 21st Century. A positive sign in that direction was the RFP DEA issued for IT support for the Diversion Control Division more than 2 years ago. Unfortunately, until that work is completed (started?), the challenges facing registrants in navigating the CSOS bureaucracy will have many longing for the days of using the carbon copy 222 forms.
So this one has to be a no-brainer. In 2009, Congress directed DEA to create a telemedicine registration category. Crickets. Presumably unaware that it had already done so, in 2018 Congress again, in the SUPPORT Act, directed DEA to promulgate regulations regarding the practice of telemedicine, with a deadline in October 2019. Crickets. It is possible that the recent delay is due to the Trump Administration’s mandate on removing two regulations for every new regulation proposed. With that said, I cannot imagine that Congress will play the “third time’s a charm” game. For that reason my money is on DEA issuing an NPRM in the first half of 2020. Note: the Magic 8 Ball says “very doubtful.”
Other Regulatory Matters
DEA is required to provide notification of regulations it intends to promulgate in the near and long term. This is referred to as the Unified Agenda. The most recent notice provided by DEA in the Fall of 2019 had a laundry list of anticipated regulatory actions. You will see that many of the matters listed by DEA have been on the list for some time. The notification is more of a wish list than concrete guidance. With that said, I would still encourage you to take a quick look at the list so you are not surprised should the stars align and one or more matters becomes an NPRM. I would consider many of the matters on the list to be minor or noncontroversial regulations. For that reason, I do expect an uptick in regulatory activity from DEA in 2020.
Unfortunately, I also predict that we will see supply shortages in 2020 and perhaps 2021, primarily for opioids. DEA is absolutely correct to try to address its past history of exponential increases in quota by reducing quotas for some of the most widely abused drugs. My belief is that medical professionals have not yet accepted responsibility for the part they played in the opioid abuse crisis and have been very slow and even resistant to changing their prescribing practices. To be clear, some have, but I believe that many more have not. This will leave patients with legitimate medical needs walking around with prescriptions that they cannot get filled due to supply issues. In time, as alternate therapies are incorporated into treatment regimens, as prescribers reduce the amount they prescribe, as insurance companies reform their practices, and as we become better educated on the risks associated with pharmaceutical controlled substances, a significantly lower supply of opioids should be required to meet the legitimate medical needs of the public. Until then, those with a legitimate need for these drugs may be forced to go without or to experiment with unsafe alternate therapies, neither of which is ideal.
Thanks for reading and I hope you continue to visit me here in 2020 and beyond. My friend says “outlook good.” I hope he is correct.
Note to the reader: While a Magic 8 Ball can help with life’s most pressing questions, the author does not use his Magic 8 Ball when providing legal advice to clients.