White House Proposes Cuts in US Opioid Production
The US Department of Justice (DOJ) and the US Drug Enforcement Administration (DEA) have proposed a reduction for controlled substances that may be manufactured in the US in 2019. The proposal decreases manufacturing quotas for six opioids for 2019 by an average of 10% as compared to the 2018 amount.
The DEA has proposed to reduce the more commonly prescribed Schedule II opioids, including oxycodone, hydrocodone, oxymorphone, hydromorphone, morphine, and fentanyl. The DEA says the move to cut opioid product is part of President Donald Trump’s Safe Prescribing Plan that seeks to cut nationwide opioid prescription fills by one-third within three years. The DEA said the quotas apply to the six most frequently misused opioids.
“The opioid epidemic that we are facing today is the worst drug crisis in American history,” said Attorney General Jeff Sessions, in an August 16, 2018 DEA statement. “President Trump has set the ambitious goal of reducing opioid prescription rates by one-third in three years. We embrace that goal and are resolutely committed to reaching it. According to the National Prescription Audit, we have already made significant progress in reducing prescription rates over the past year. Cutting opioid production quotas by an average of ten percent next year will help us continue that progress and make it harder to divert these drugs for abuse.”
The DEA’s proposed rule marks the third straight year of proposed reductions, according to the DEA. Last month (July 2018), the DOJ announced that the DEA was issuing a final rule amending its regulations to improve the agency’s ability to consider the likelihood of whether a drug can be diverted for abuse when it sets annual opioid production limits. The final rule also promotes greater involvement from state attorneys general, and the proposed reductions will be sent to those offices.
In setting the aggregate production quota, the DEA says it considers data from many sources, including estimates of the legitimate medical need from the US Food and Drug Administration; estimates of retail consumption based on prescriptions dispensed; manufacturers’ disposition history and forecasts; data from DEA’s own internal system for tracking controlled substance transactions; and past quota histories.
Once the aggregate quota is set, the DEA allocates individual manufacturing and procurement quotas to those manufacturers that apply for them. The DEA may revise a company’s quota at any time during the year if change is warranted due to increased or decreased sales or exports, new manufacturers entering the market, new product development, or product recalls.
When Congress passed the Controlled Substances Act,the quota system was intended to reduce or eliminate diversion from “legitimate channels of trade” by controlling the quantities of the basic ingredients needed for the manufacture of controlled substances.
The Proposed Aggregate Production Quotas for Schedule I and II controlled substances published in the Federal Register reflects the total amount of controlled substances necessary to meet the country’s medical, scientific, research, industrial, and export needs for the year and for the establishment and maintenance of reserve stocks. The DEA establishes an annual production quota for more than 250 Schedule I and II controlled substances annually.