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.”
Taking Diversion Into Account
Added to the calculus this year, however, were the directives of the SUPPORT Act, passed last year, which requires DEA, when it comes to the Big Five opioids, to estimate the diversion amounts for each drug and reduce the quota for each accordingly. These diversion estimates are based on 2018 numbers and appear in the Notice as follows (in kg):
- Fentanyl 0.109
- Hydrocodone 24.259
- Hydromorphone 1.219
- Oxycodone 57.051
- Oxymorphone 1.157
Because of the analytical effect of the usual factors, these diversion estimates do not, by themselves, track the decreases in the quotas for the particular drugs, but it is useful to note that they now play a role in the setting of the aggregate quotas. Unfortunately, we do not have diversion numbers from previous years, which may prove useful in assessing the impact.
How Do These Numbers Stack Up: Hydrocodone and Oxycodone?
That said, it is useful to take a look at these 2020 numbers in light of the aggregate production quota history. The history is striking. Take hydrocodone, for example. From 2000 to 2015, the DEA either increased or kept constant the aggregate production quota number, moving from 21,417,000 in 2000 to a high-water mark of 99,625,000 in 2013, 2014, and 2015. The number has declined since, beginning with a reduction to 86,000,000 in 2016 to the 2020 quota: 34,836,854, which falls below even 2005 levels.
Oxycodone quotas have taken a similar path, with occasional minor decreases, but reflecting a steady increase over time from 35,850,000 in 2000 to a high point of 153,750,000 in 2013. The numbers began to decrease precipitously in 2017, culminating in the 2020 quota of 72,593,983, less than half of the 2013 quota and falling just over the 2008 number.
- Will significant decreases in aggregate production quotas lead to significant decreases in diversion of and/or overprescribing of opioids? We do not have enough data right now to arrive at a conclusion on this question, but it is something we should and will be tracking.
- Will the dramatic decrease in quotas continue to cause changes in prescribing patterns as supply continues to decrease?
- Will these decreases in aggregate production quotas still permit the market to fulfill the legitimate medical/patient needs for these drugs? To that end, it will be interesting to see what, if any, comments are submitted by industry seeking to increase the quotas given the possibility of drug shortages resulting from the quota decreases.