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USDA and USDOJ Propose Significant Opioid Manufacturing Reduction

The Department of Justice and U.S. Drug Enforcement Administration have proposed a reduction for controlled substances that may be manufactured in the U.S. 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 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.

“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.”

U.S. Attorney for the District of Hawaii, Kenji M. Price, commented: “Across the country, and even here in Hawaii, the opioid epidemic is taking precious lives. We applaud this effort by the DEA to stem the tide of this epidemic by seeking to limit the ways in which these drugs are able to make their way into our communities here in Hawaii.”

“We’ve lost too many lives to the opioid epidemic and families and communities suffer tragic consequences every day,” said DEA Acting Administrator Uttam 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.

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