In a joint statement by the U.S. Department of Justice and the Drug Enforcement Administration, the government announced continued efforts to tackle the opioid crisis by reducing the quantity of controlled substances permitted to be manufactured next year. The proposal decreases the 2019 Aggregate Production Quotas (APQ) for six of the most frequently misused opioids by an average of ten percent compared to 2018 quotas. The proposed production quotas for the six opioids will cut the 2018 quotas from 7% to 15% in 2019. The proposal seeks to advance the effort taken by President Trump’s “Safe Prescribing Plan,” which aims to “cut nationwide opioid prescription fills by one-third within three years.” The six drugs addressed by this action are oxycodone, hydrocodone, oxymorphone, hydromorphone, morphine, and fentanyl.
It appears that the percentage reduction of quota for these six drugs was not based on diversion statistics compiled by DEA and the Notice does not otherwise provide specific justification for the reduction in quota. In the joint statement, the government indicated that the goal of the reduction is to “encourage vigilance on the part of opioid manufacturers, help DEA respond to the changing drug threat environment, and protect the American people from potential addictive drugs while ensuring that the country has enough opioids for legitimate medical, scientific, research, and industrial needs.”
This marks the third straight year that the DEA has proposed such APQ reductions for controlled substance manufacturing in the U.S., a trend that does not appear to be slowing down. In addition to the government’s stated goals, it will be interesting to see whether continued quota reductions impact the root cause of the ongoing epidemic – the over-prescribing of controlled substances.