WASHINGTON – The Department of Justice and U.S. Drug Enforcement Administration (DEA) 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:
Chart:
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.”
“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.”
“The effect of the opioid epidemic could not be clearer – American life expectancy is shorter for the first time in decades,” United States Attorney for the Northern District of Iowa Peter E. Deegan, Jr. stated. “Heroin and prescription opioid abuse have taken a devastating toll on communities in this district and my office is committed to prosecuting those who distribute these dangerous drugs. But criminal prosecutions alone will not protect our communities. Reducing the amount of prescription opioids on the street and the number of people who become addicted to prescription opioids is another important step in addressing the opioid epidemic.”
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.
D.E.A. agent gets shot in the line of duty. Is in a LOT of pain. Will he/she receive a couple Tylenol and an admonition to “Suck it up” like us “common folk”? Yeah. Right. More likely a morphine drip while in hospital + bottles of morphine pills & oxy-whatever to take home. With multiple refills allowed.
Hmm… Let’s see: Reducing opioid manufacturing will reduce deaths? Um…Excuse me…I am no statistician, but I’m reasonably sure that ALCOHOL has sent FAR more many people to an early demise than ALL OPIOIDS (including heroin) COMBINED. Doesn’t President Trump own one or more establishments that earn profits from sales of alcohol? And I seriously doubt that DEA agents, or ANY OTHER law enforcement officers, nor politicians, abstain. In other words, law enforcement officers DO add to the profits of “the demon in the bottle”. HYPOCRITES ALL!!! Oh…and then there are TOBACCO products. Like alcohol, legal…harmful…no Rx required. So the “Save the World” by denying PROVEN pain remedies to both ABUSERS…and RESPONSIBLE USERS that have no other source of EFFECTIVE pain relief…Other than alcohol or street drugs.
Just hope you don’t go thru surgery. They aren’t handing out pain pills. Tylenol doesn’t do it you just suffer not fun.
Good luck on controlling this problem. Maybe they should join the DARE program.
I do not believe that LEGAL drugs are the problem. There are people in pain that desperately need them. Close down the border and smugglers bringing in the ILLEGAL drugs and the problem will disappear.
You are so ignorant. Please stop commenting on subjects you know nothing about.
You really are that stupid aren’t you?
You should really do some research. I don’t think Florida and Ohio are in Mexico. The pills they are pushing are all made by American pharmaceutical companies. You’re Republican buddies are getting rich off of this and you think that these drugs are coming over the border? Like I said, do some research and you look less like a fool
http://www.metrowestdailynews.com/news/20180708/how-florida-spread-oxy-across-half-of-america?template=ampart
Here is some more evidence for you that this is a domestic problem. Pretty sure Cardinal Health, CVS and Walgreens are all American companies. They have nothing to do with the border or illegal drugs.
It only takes a little research to make you look like a fool
“Cardinal Health, one of the nation’s biggest distributors, sold two CVS pharmacies in Sanford a combined 3.4 million doses of oxycodone, flooding the town of 53,000 with an average of 283,000 oxycodone pills every month.
West of Jupiter, a Walgreens drug distribution center was the single supplier of oxycodone in Florida. It sold 2.2 million tablets to a single Walgreens’ pharmacy in tiny Hudson, a roughly five-month supply for each of its 12,500 residents. It shipped more than 1.1 million pills to each of two Fort Pierce Walgreens pharmacies.”
Whatever happened to a few cocktails to unwind. These pills are bad news as is meth. Big Pharma used the doctors to push these pills for a lucrative deal that made them millions. And the doctors felt jilted as all these government regulations stymied their wealthy careers so it was something they feel they had to do. If you think hospital shows on TV have drama get a job a Mercy. The gossip going on there is beyond belief. I am Doctor therefore I am God my ass. Flunkies in following their Hippocratic Oath.