On April 19, 2018, the Drug Enforcement Administration (DEA) issued a Notice of Proposed Rule Making (NPRM) proposing various changes to DEA’s process for setting Aggregate Production Quotas (APQ) and Individual Procurement Quotas (IPQ). Here are some of the more significant “changes” proposed in the NPRM:
Aggregate Production Quotas
- DEA must consider the diversion of a particular class of drugs when setting APQ;
- DEA must also consider information from HHS, FDA, CDC, CMA, and state information when setting APQ;
- DEA must consider diversion as one of the factors for adjusting APQ;
- Allows for a hearing, if requested, and necessary to resolve issues related to a state’s objection to changes in APQ.
Individual Procurement Quotas
- DEA may require certain customer information from manufacturers when setting IPQs;
- DEA may include diversion as a factor for setting IPQs.
While I would normally applaud DEA’s efforts addressing the prescription drug abuse epidemic, the NPRM, in my mind, is more window dressing than it is a substantive change in how DEA sets APQ and IPQ. In fact, DEA has publicly stated that it has relied on the very factors that are being added to the current regulations. But don’t take my word for it. Check out slides 45 and 46 of this presentation given by DEA in 2013.
Under current regulations, DEA has wide latitude when issuing quotas. As acknowledged in the NPRM, there is currently a catch-all factor in the regulations that allows DEA to consider any factor that DEA deems relevant when setting quota. Any reasonable (and perhaps unreasonable) person would expect that DEA would factor in the diversion of a particular class of controlled substances when setting quota. The same can be said for the “new” requirement proposed in the NPRM that DEA should issue 2019 quota well in advance of that quota year. Again, the Controlled Substances Act and DEA’s current regulations have always required DEA to issue quota well in advance of the upcoming quota year. DEA just never did so, at least going back the last decade or more.
While I do not know this to be true, my first thought when reading the NPRM was that the NPRM was either drafted by, or mandated by, the Department of Justice. As the prescription drug abuse epidemic increasingly ravaged our communities, the DEA officials responsible for setting quota ignored the diversion of certain classes of controlled substances when setting quota despite their clear authority to consider diversion information and/or information from other federal and states agencies when setting quota. Likewise, as I have previously stated, DEA routinely failed to set quota well in advance of the upcoming quota year and in accordance with its statutory and regulatory obligations to do so. In my mind, the NPRM is more of a reminder to DEA than it is imposing new requirements when setting quota.
Perhaps the most important takeaway from this NPRM is the implicit acknowledgement by DEA (DOJ?) of the agency’s past failures when setting (and exponentially increasing) quota during the growth of the prescription drug epidemic. Even though the NPRM mostly reiterates and mandates DEA’s use of authority it already has, hopefully the resulting clarification in the regulations will ensure that current and future DEA officials will not make the same mistakes that previous officials made when setting quota.