United States Attorney and Cherokee Nation Attorney General Voice Support for Significant Opioid Manufacturing Reduction in 2019

TULSA, Okla. – United States Attorney Trent Shores and Cherokee Nation Attorney General Todd Hembree joined together to voice their support for a Department of Justice and U.S. Drug Enforcement Administration (DEA) proposal for a reduction of controlled substances that may be manufactured in the United States next year. Consistent with President Trump’s “Safe Prescribing Plan” that seeks to “cut nationwide opioid prescription fills by one-third within three years,” the proposal decreases manufacturing quotas for the most six frequently misused opioids for 2019 by an average ten percent as compared to the 2018 amount. The Notice of Proposed Rulemaking (NPRM) marks the third straight year of proposed reductions, which help reduce the amount of drugs potentially diverted for trafficking and used to facilitate addiction.

On July 11, 2018, the Justice Department announced that 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 today’s proposed reduction will be sent to those offices.

In setting the aggregate production quote (APQ), DEA considers data from many sources, including estimates of the legitimate medical need from the 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.

The DEA has proposed to reduce more commonly prescribed schedule II opioids, including oxycodone, hydrocodone, oxymorphone, hydromorphone, morphine, and fentanyl:

Ultimately, revised limits will 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.

Tribal communities throughout the United States have also been impacted by the deadly opioid epidemic. The Cherokee Nation is a federally recognized Indian tribe located in northeast Oklahoma and is one of the largest Indian tribes in the United States. Cherokee officials have noted that their communities are grappling with the financial and social burdens of the opioid epidemic. On Tuesday, the Cherokee Nation hosted more than 30 United States Attorneys from across the United States who work in federal districts with Indian tribes and tribal land. These U.S. Attorneys comprise the Native American Issues Subcommittee (NAIS), the longest standing subcommittee of the Attorney General’s Advisory Committee. The Cherokee Nation Principal Chief and Attorney General spoke to the NAIS about the impact of the opioid epidemic on the Cherokee people, especially as it affects Cherokee children. According to the Centers for Disease Control and Prevention, the rate at which babies have been born with a drug withdrawal syndrome that can occur because they were exposed to prescription painkillers or heroin in the womb has quadrupled over the course of 15 years in the U.S.

"The opioid epidemic that we are facing today is the worst drug crisis in American history," Attorney General Jeff Sessions said. "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 American people can be confident that federal law enforcement and the Trump administration are taking action to protect them from dangerous drugs.  These smarter limits bring us one big step closer to President Trump's goal of finally ending this unprecedented crisis. I congratulate Acting Administrator Uttam Dhillon and his team for taking action.”

United States Attorney Shores stated, “Drugs are killing more Oklahomans than ever before. We must work together with our state and tribal partners to combat this overdose epidemic. This social catastrophe is literally killing our younger generations before their time. I am proud to work with the Cherokee Nation to stop the proliferation of these dangerous drugs. I applaud Attorney General Sessions and DEA Acting Adminstrator Dhillon for their leadership to reduce prescription rates.”

“The Cherokee Nation and eastern Oklahoma have been at the epicenter of the opioid epidemic.  This has effected countless families and threatens a generation of Cherokee mothers and children who’ve been exposed to these drugs,” Cherokee Nation Attorney General Todd Hembree said. “I applaud the efforts of United States Attorney Shores in acting in coordination with tribes to end this epidemic. By limiting the amount of opioid drugs that may be manufactured we can begin to curb the flow of such drugs into our tribal communities.”

“We’ve lost too many lives to the opioid epidemic and families and communities suffer tragic consequences every day,” said Acting Administrator Dhillon. “This significant drop in prescriptions by doctors and DEA’s production quota adjustment will continue to reduce the amount of drugs available for illicit diversion and abuse while ensuring that patients will continue to have access to proper medicine.”

Once the aggregate quota is set, DEA allocates individual manufacturing and procurement quotas to those manufacturers that apply for them. 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. DEA establishes an APQ for more than 250 schedule I and II controlled substances annually.

In 2016, the Centers for Disease Control and Prevention issued guidelines to practitioners recommending a reduction in the prescribing of opioid medications for chronic pain. DEA and its federal partners have increased efforts in the last several years to educate practitioners, pharmacists, manufacturers, distributors, and the public about the dangers associated with the misuse of opioid medications and the importance of proper prescribing.