W.Va. AG leads push for DEA to better account for illicit use of opioids
https://www.journal-news.net/w-va-ag-leads-push-for-dea-to-better-account/article_363661f4-24a7-5b49-b3b0-8fb3a7e25277.html
HUNTINGTON — A group of attorneys general led by West Virginia Attorney General Patrick Morrisey are pushing federal regulators to better track illicit use of opioid painkillers, an effort to capitalize on sweeping reforms achieved by Morrisey’s prior lawsuit against the U.S. Drug Enforcement Administration.
The coalition of six states, in comments on a proposed rule, identified 16 specific ways the DEA can better account for diversion when setting the number of pills that can be manufactured each year. The suggestions come in response to agency concerns that it is unable to accurately track pills diverted for non-medical use.
“The opioid crisis is a never-ending battle,” Morrisey said in a release. “Responsible, research-backed quotas are an essential tool in our continued fight. We will never have a full and accurate picture of the legitimate medical, scientific and industrial need without the DEA improving its methodology. We have to do all we can to stop senseless death.”
The coalition’s 16 suggestions include ways to better use six national databases that track the scope and magnitude of opioid abuse. That includes two systems already housed within the DEA, along with the National Survey on Drug Use and Health, a database that tracks the treatment of drug abuse episodes and two others that track poisonings.
The coalition further suggests the DEA consult nine similar state databases and, separately, take into greater account information from its Drug Take Back Day as evidence of overprescribing.
The coalition acknowledges that no database is perfect or all-inclusive, but its members contend there is still plenty of material that when reviewed from different angles can help the agency better account for diversion and thereby gain a more accurate picture of the nation’s medical, scientific and industrial need.
In October, a U.S. Department of Justice inspector general report found the DEA was slow to respond to the opioid crisis. The report said between 2013 and 2017, the DEA significantly reduced using one of its key enforcement tools — the ability to suspend manufacturers, distributors and other registrants to keep drugs from being diverted.
Following Morrisey’s lawsuit in late 2017, the DEA enacted sweeping reforms to its drug quota system that embraced the attorney general’s call for greater input and consideration of diversion in determining how many opioid pills can be manufactured each year.
The DEA previously relied on the amount of pills pharmaceutical manufacturers expected to sell within a year. The broken approach did not account for the number of pills diverted for abuse, Morrisey said.
The DEA’s proposed limits for 2020 slash hydrocodone manufacturing by 19% and oxycodone by 8.8% in one year.
West Virginia filed the comments with support from attorneys general in Arkansas, Florida, Kentucky, Missouri and Nebraska.
DEA proposes to reduce the amount of five opioids manufactured in 2020, marijuana quota for research increases by almost a third
WASHINGTON – The U.S. Drug Enforcement Administration is proposing to reduce the amount of five Schedule II opioid controlled substances that can be manufactured in the United States next year compared with 2019, per the Notice of Proposed Rulemaking being published in the Federal Register tomorrow and available for public inspection here today.
DEA proposes to reduce the amount of fentanyl produced by 31 percent, hydrocodone by 19 percent, hydromorphone by 25 percent, oxycodone by nine percent and oxymorphone by 55 percent. Combined with morphine, the proposed quota would be a 53 percent decrease in the amount of allowable production of these opioids since 2016.
DEA proposes to increase the amount of marijuana that can be produced for research by almost a third over 2019’s level, from 2,450 kilograms to 3,200 kilograms, which is almost triple what it was in 2018. This will meet the need created by the increase in the amount of approved research involving marijuana. Over the last two years, the total number of individuals registered by DEA to conduct research with marijuana, marijuana extracts, derivatives and delta-9-tetrahydrocannabinol (THC) has increased by more than 40 percent, from 384 in January 2017 to 542 in January 2019.
“The aggregate production quota set by DEA each calendar year ensures that patients have the medicines they need while also reducing excess production of controlled prescription drugs that can be diverted and misused,” said Acting Administrator Uttam Dhillon. “DEA takes seriously its obligations to both protect the public from illicit drug trafficking and ensure adequate supplies to meet the legitimate needs of patients and researchers for these substances.”
The Proposed Aggregate Production Quotas and Assessment of Annual Needs being published in the Federal Register addresses more than 250 Schedule I and II controlled substances and three List I chemicals, which include ephedrine, pseudoephedrine, and phenylpropanolamine. This reflects the total amount of substances needed to meet the country’s legitimate medical, scientific, research, industrial and export needs for the year and for the maintenance of reserve stocks. DEA endeavors to set production limits at a level required to meet these needs, without resulting in an excessive amount of these potentially harmful substances.
In setting the 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 internal system for tracking controlled substance transactions; and past quota histories. As a result of new laws and regulations that took effect in 2018, the number of factors that DEA considers in setting the APQ has increased. Information on these factors and how they were assessed appears in the Notice.
The five opioid substances were subject to special scrutiny following the enactment last year of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act, known as the SUPPORT Act, which requires DEA to “estimate the amount of diversion of the covered substance that occurs in the United States” and “make appropriate quota reductions. DEA’s estimates of the amount of diversion that took place for each of these five opioid substances and how those estimates were calculated appear in the Notice.
Interested parties may submit public comments on the proposed APQ until 11:59 p.m. on October 10, following the instructions in the Notice. After taking the comments into account, DEA will publish another notice later in the year informing the public of the established APQ. After that, 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 sales or exports, new manufacturers entering the market, new product development, or product recalls.
Filed under: General Problems
We need to write to these AG:s IF we can find out how and who they all are.
These AG’s talk about senseless deaths? Oz How about the senseless deaths caused by chronic pain? It’s rampant. These AG’s are such Liars! I looked for a place to leave a comment on the article but of course,.. they don’t want to hear from the public because they know, they would be hammered by THE People. My God these idiots don’t know when to Quit.
Unfu**ing believable!!!
AGAIN Its a bunch of BOZO’s that have no clue. No where in the article did it mention “while still able to get medication to the millions who depend on it for some quality of life!” The idiots have to look no further than the streets if they want to stop “meaningless deaths” Its not prescribed medication that is the problem. Like all the other “research studies” that come out 3 yrs after we know,Im sure in 3 years they will come out claiming its illegal pills,heroin and fentanyl coming through the borders thats causing “meaningless deaths!”
The coalition cites “we have to do all we can to stop senseless death”. What about the senseless, relentless, suffering caused by pain generating disease, hard manual lifetime labor, accidental and recreational injury, even doctor screw ups admitted by the “experts” ? What do WE do without an efficient, properly monitored, documented use of the now proclaimed “evil” opioid MEDICATIONS depended on for years and decades without an effective treatment for accepted (by the experts) lifetime, continuous pain? Slash production further (of MEDICATION) for the ever growing numbers of suicidal pain management patients? What of the vast majority of prescribed patients with a history, again of documented success and positive use of the evil opioids? What of this not small, populous of people /patients? Continued agony in many cases, loss of job/income, social responsibilities/activity leading to worsening health? The afore mentioned is “acceptable”?
This is so wrong. It’s not an opioid problem we have. It’s a heroi/meth/cocaine street drugs and shipping all these drugs that have deadly amount of other chemicals in them and they mix these street drugs together that’s when they overdose. It’s not fair to drop the amount of opiods because you are taking meds away from the people who are taking their pain medicines as prescribed under doctor care. The DEA doesn’t deserve to be sued. The people that OD caused it alby themselves. They are the ones that put 10 pills down their throat at one time, they are the ones who take multiple amounts of different pain meds so they get their high and not one doctor is prescribing multiple opiods to a patient. You are going to cause the people with the rare diseases chronic pain sufferers to commit suicide because they have no pain relief. Instead focus on where all the street drugs are coming in from and get those off the streets. Druggies will always be drug addicts they will never change so don’t make innocent people suffer because of the sick druggies stupid decision to shove any amount of street drugs into their body.
Stop blaming the doctors when all they are doing is their Job. I had enough of this bullcrap. When we chronic pain patients need our meds we shouldn’t have any problems getting them from our pharmacist. DON’T TAKE OUR PAIN MEDS AWAY. WE ARE NOT DRUG ADDICTS. WE ARE PEOPLE THAT GOT SICK CHRONICALLY IN PAIN WITH A RARE DISEASE INNOCENTLY. OPIODS HELP EASE OUR PAIN. DON’T LOWER THE QUANTITY OF PAIN MEDS THAT WE NEED, ITS NOT OUR FAULT DRUGGIES WANT TO MISUSE DRUGS AND THEY CAUSE THEIR OWN DEATH. WE AREN’T GUILTY AND WE DON’T NEED TO SUFFER ANYMORE FROM THE PEOPLE/DRUGGIES DUMB CHOICES THEY ARE MAKING WHICH ENDS UP IN AN OVERDOSE DEATH. DO YOU PUNISH INNOCENT PEOPLE FOR A CRIME DONE BY SOMEONE ELSE? NO. DO WE ALL SERCE TIME IN JAIL FOR A CRIME SOMEONE DOES? NO, THEN DON’T PUNISH US BY TAKING AWAY OUR ONLY MEANS TO HAVE SOME QUALITY OF LIFE BACK. DON’T TAKE AWAY OUR PAIN MEDICATION. THIS IS SO UNFAIR.
They still want to think that “opioid crisis” is millions and millions of patients prescribed by Doctors of Medicine. It NEVER was…