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.
Here is a snapshot:
|Drug||Proposed 2021 Quota (g)||Vs. Original 2020 Quota||Vs. Adjusted 2020 Quota|
As you can see, with the exception of oxymorphone, the proposed quotas are down significantly for the Big Five, from both the original 2020 quotas and the adjustments we saw both in April and yesterday.
Some of the reduction may be explained by DEA’s April adjustments, which were largely in response to the coronavirus pandemic. DEA increased the quotas for particular substances related to the treatment of the virus, including fentanyl, oxymorphone, and hydromorphone.
Now, under the SUPPORT Act, when arriving at the aggregate production quota, DEA must estimate the amount of diversion of any “covered controlled substance,” (i.e., the Big Five.) So how does DEA arrive at these diversion estimates? Well, under the SUPPORT Act, when analyzing diversion rates, DEA is charged with acting “in consultation” with HHS to determine “rates of overdose deaths and abuse and overall public health impact related to the covered controlled substance…” (DEA may also consult any other source it deems reliable.) DEA did not find most of the consultations particularly helpful apparently, finding both the CDC information on the rates of overdose deaths and the CMS information on rates of overprescribing either incomplete or unreliable for estimating diversion.
DEA fared better with the FDA apparently, but even here there was a wrinkle. FDA is responsible for providing “estimates and predictions of legitimate medical needs” for controlled substances in a calendar year. Quite an estimate it was too. FDA’s predicted level of medical need was “expected to decline on average 36.52 percent for calendar year 2021.” Wow. That said, “FDA’s predicted level of medical need for the United States was calculated by FDA at the beginning of the Coronavirus . . . pandemic and, therefore, did not take into account changes in usage that are necessary to treat patients who require schedule II controlled substances.”
I should note here, however, that DEA did “consider FDA’s concerns” over potential shortages in ADHD medications (amphetamine, methylphenidate, and lisdexamfetamine) when calculating its quotas for these controlled substances. But DEA also indicated that it “has grown increasingly concerned over the misuse of prescription stimulants among young adults and the demand for methamphetamine in the U.S.” This concern is leading DEA to “closely” monitor “trends in licit stimulant use.” The numbers indicate DEA largely held steady on the quotas for these stimulants.
Finally, DEA mentions that nine states’ attorneys general submitted PDMP data in response to a DEA request. “The data that DEA received varied in its form and content,” however, “and was ultimately determined to be inapplicable at the national level.”
So, for the most part and as DEA has historically done, DEA used its own internal reports to arrive at its diversion numbers for the Big Five. And, given the FDA’s whopping prediction about the decrease in medical need, the quota decreases may not be so dramatic as they might have been. The historic and ongoing conflict between DEA’s assessment of the legitimate medical needs of the United States versus FDA’s assessment does not seem to be abating. It will be interesting to see what, if anything, Congress will have to say about this.