DEA Plans More Cuts in Opioid Supply, While Raising ADHD Stimulant Production

By Pat Anson

The U.S. Drug Enforcement Administration is planning more cuts in the supply of prescription opioids in 2025, while raising production of amphetamine and other stimulants used to treat attention-deficit/hyperactivity disorder (ADHD).

If the DEA’s plans are finalized after a public comment period, it would be the ninth consecutive year the opioid supply has been reduced.

Under the Controlled Substances Act, the DEA has broad legal authority to set annual aggregate production quotas (APQs) for drug makers – in effect telling them how much Schedule I and II chemicals and medications they can produce. DEA sets the quotas after consulting with the Food and Drug Administration (FDA) and other federal agencies, as well as individual states about the projected need for controlled substances.

“FDA predicts that levels of medical need for schedule II opioids in the United States in calendar year 2025 will decline on average 6.6 percent from calendar year 2024 levels. These declines are expected to occur across a variety of schedule II opioids. These declines are expected to occur across a variety of schedule II opioids,” the DEA said in a notice recently published in the Federal Register.

There will not be 6.6% cuts across the board for every opioid. Unlike previous years, the agency is proposing only slight reductions in the supply of fentanyl, oxycodone, hydrocodone and hydromorphone, while keeping quotas unchanged for morphine and codeine.

Most of the cuts are very minor – less than a tenth of one percent -- when the proposed APQ’s for 2025 are compared to the ones adopted in 2024.

DEA Opioid Production Quotas for 2025

• Fentanyl: 0.0025% decrease

• Oxycodone:  0.137% decrease

• Hydrocodone: 0.081% decrease

• Hydromorphone: 0.015% decrease

• Morphine: Unchanged

• Codeine: Unchanged

The DEA notice does not address the discrepancy between the FDA’s estimate of a 6.6% decline in medical need for opioids with the quotas it is proposing. The agency says it considered a “potential increase in demand for certain opioids” due to more elective surgeries being performed in 2025. Many of those surgeries were postponed during the COVID-19 pandemic.

The FDA predicted a 3.5% increase in domestic medical use of Schedule II stimulants in 2025. Demand for stimulants to treat ADHD has grown in recent years, but the drugs are also increasingly used to treat brain fog and fatigue caused by Long Covid. The FDA told DEA it was concerned about ongoing shortages of amphetamine, lisdexamfetamine, and methylphenidate, which are used to make stimulants such as Adderall.    

The DEA wants to raise production quotas for amphetamine (+5.9%) and lisdexamfetamine (+23.5%), while leaving the 2025 quota for methylphenidate the same as it was in 2024. The agency said inventories of amphetamine and methylphenidate-based products had increased, while shortages of lisdexamfetamin continue.

“DEA believes that manufacturers will be able to meet the increase in domestic medical need for these three schedule II stimulants with the APQs proposed in this notice,” the agency said.

The Myth of Opioid Diversion

The DEA has been cutting opioid production quotas for nearly a decade, reducing the supply of oxycodone by over 68% and hydrocodone by nearly 73% since 2015. Many of those cuts are due to pressure from Congress, as well as a common belief that prescription opioids are often diverted or sold to people they are not intended for.

That belief is largely a myth.

As required by Congress, DEA estimated the diversion rate of schedule II opioids in 2025, and once again came to the conclusion that diversion is rare – less than half of one percent for oxycodone and hydrocodone. Much of the diversion is a result of theft and losses in the supply chain, before opioids even reach patients.

Estimated 2025 Diversion Rates

• Oxycodone: 0.493%

• Hydrocodone: 0.379%

• Fentanyl:  0.013%

• Hydromorphone: 0.06%

The DEA’s diversion rates are partially based on “red flag” data from prescription drug monitoring programs (PDMP). Potential red flags include patients who see three or more prescribers in a 90-day period; patients who receive a daily opioid dose in excess of 240 morphine milligram equivalents (MME); and patients who pay in cash for a controlled substance.

DEA requested PDMP data from all 50 states, but only 29 states responded to the request by sharing summaries of their red flag data.

“While PDMP data is useful in estimating diversion, it is not conclusive. Further investigation would be required before concluding that any of the subject prescriptions were actually diverted. DEA continues to evaluate its methodologies in estimating diversion in an effort to set quotas more efficiently. State participation is crucial to accurate data analysis, and DEA anticipates working closely with states, as well as other federal and state entities, in future quota determinations,” the agency said.

Public Comments

The DEA quietly published its notice about 2025 production quotas in the Federal Register on September 25, with no fanfare or press release.

Usually the agency receives thousands of comments from the public about its production quotas, but so far there have been only a handful of comments posted. Many are from patients still bitter about the decade of cuts the DEA has imposed on the opioid supply, which have contributed to record shortages of prescription drugs.

“The actions that are being taken by Congress, by the DEA, state legislatures, and state medical boards, have caused THOUSANDS of these patients to lose access to their medications, have resulted in the improper prosecution of pain doctors, resulting in a severe nationwide shortage of pain specialists, and nationwide shortages of medications,” wrote David Smith.  

“The CDC, FDA, and DEA have severely underestimated the needs of chronic pain patients and misjudged the consequences of these cuts. While opioid misuse is a serious issue, penalizing legitimate pain patients is not the solution,” said Gina Harrison.

“Please I'm begging you not to cut opioids meds this year,” said Melissa Guthrie. “I'm on palliative care and there were a couple months last year I didn't get my meds due to shortages. You know it's not the pain meds causing harm. It’s the illicit fentanyl and street drugs killing people.”

You still have time to make your feelings known, as long as you do it by October 25, when the public comment period ends. To make a comment, click here.

U.S. Drug Shortages Reach Record Levels

By Pat Anson, PNN Editor

Shortages of opioids and other medications reached a record level in the U.S. during the first quarter of 2024, according to the American Society of Health-System Pharmacists (ASHP). The 323 medications listed in short supply are the highest number since the ASHP began tracking drug shortages in 2001.

Some of the most acute shortages are for basic, life-saving injectable drugs used in hospitals for pain control, sedation and chemotherapy.

Most of the drug manufacturers contacted by the ASHP did not provide a reason for the shortages, but some blamed supply/demand issues (14%), manufacturing problems (12%), business decisions (12%) and raw material issues (2%).

The ASHP also cited reduced DEA production quotas and the fallout from opioid litigation settlements, which have curtailed the supply of opioid medication at many pharmacies.

“New DEA quota changes, along with allocation practices established after opioid legal settlements, are exacerbating shortages of controlled substances,” the ASHP said in its latest report.

The Drug Enforcement Administration has been cutting opioid production quotas for nearly a decade, reducing the supply of oxycodone by over 68% and hydrocodone by nearly 73% since 2015. The DEA says it acts on the advice of the Food and Drug Administration, which projected a 7.9% decline in the “medical need” for opioids in 2024, months before the new year even began.

Many pain patients question whether the demand for opioids is really going down. In a recent PNN survey, 90% of patients with an opioid prescription said they had trouble getting it filled at a pharmacy. Nearly 20% were unable to get their pain medication, even after contacting multiple pharmacies.

“The pharmacist said they could not get my medication because the supplier informed them that they had reached their yearly max and the DEA would not let them supply anymore medication,” one patient told us.

“I am terrified of the cuts being pushed by the DEA,” said another patient. “Several times I have had to wait over a week until my local CVS got my medication back in stock. Honestly, I have such intolerable pain I had no choice but to turn to illicit street drugs to fill in the gaps.”

Shortages of stimulants used to treat attention-deficit/hyperactivity disorder (ADHD) get far more attention than shortages of opioids, which the FDA and DEA have largely ignored. The DEA modestly raised production quotas for ADHD drugs in 2024, but they remain in short supply.

About 12% of the 323 drugs currently listed in shortage by the ASHP are controlled substances regulated by the DEA because they are potentially addictive.

University of Utah Drug Information Service

“I can’t say for sure that every single controlled substance shortage is due to quota issues, but it’s a contributing factor for some,” says Erin Fox, PharmD, Senior Pharmacy Director at University of Utah Health, which tracks drug shortages for the ASHP. “DEA changed their quota process to try to help with ADHD drug shortages, but didn’t take into account how their change affects injectable manufacturers.”

Fox shared a recent letter sent by Pfizer to U.S. hospitals warning of “additional supply interruptions and potential stock outs” due to DEA quota changes. The letter warns of limited supplies of several injectable medicines made by Pfizer, including meperidine (Demerol), hydromorphone and morphine.  

“I understand that DEA is working to prevent drug diversion and was under fire for the ADHD medication shortages, but injectable manufacturing is very different than oral products and DEA did not take into account all of the special processes that are required for injectables,” Fox said in an email to PNN.

Nearly half of the drugs on the ASHP’s shortage list are injectables. Opioids, stimulants and other drugs that affect the central nervous system are the leading class of medication in short supply, followed by antibiotics, hormonal agents, and chemotherapy drugs.

The FDA, which uses a different system to track drug shortages, currently lists only 153 medications in short supply, less than half the number listed by the ASHP.

DEA Finalizes More Cuts in Rx Opioid Supply in 2024

By Pat Anson, PNN Editor

The U.S. Drug Enforcement Administration will further reduce the supply of codeine, morphine, oxycodone and other prescription opioids in 2024, ignoring complaints from thousands of patients that opioid pain medication is already difficult to obtain and many pharmacies are out of stock.

In a notice pre-published Friday in the Federal Register, the DEA said it would stick with plans to cut aggregate production quotas (APQs) for prescription opioids for the eighth consecutive year, reducing the supply to levels not seen in nearly a decade.

“After considering all of the relevant factors, DEA has determined that the APQs of prescription opioids should be reduced from calendar year 2023 APQ levels and they are sufficient to meet the forecasted domestic and foreign medical needs,” the DEA said.

Under the Controlled Substances Act, the DEA has broad legal authority to set APQs annually for hundreds of Schedule I and II chemicals and medications – in effect telling drug manufacturers how much they can make each year.

Acting on the advice of the Food and Drug Administration, which estimates there will be a be a 7.9% decline in medical need for opioids next year, the DEA in early November published its proposed APQs for 2024 in the Federal Register and invited public comment.      

Nearly 4,700 comments came in, mostly from pain patients worried that further cuts in the opioid supply would worsen shortages and interfere with their treatment.  

“I am pretty much bed bound. A couple of weeks ago I tried taking my life,” one patient wrote. “No one should have to suffer like this. These are medications that work. And why is it that the prescriptions have gone down but overdoses have gone up?”

“Please do not cut the Rx opioid production amount anymore. There is a severe shortage and many people who have prescriptions cannot get them filled at a pharmacy,” another poster said.

The American Society of Health-System Pharmacists (ASHP) has been warning about shortages of hydrocodone and oxycodone for months, but those shortages have yet to be recognized by the FDA or DEA.  If any shortages exist, DEA said they were out of its control and blamed the “temporary lack of inventory” on drug manufacturers.

“DEA utilizes the available, reliable data and information received by the agency at the time APQs are proposed and proactively monitors drug production, distribution and supply during the year. However, drug shortages may occur subsequently due to factors outside of DEA control such as manufacturing and quality problems, processing delays, supply chain disruptions, or discontinuations,” the agency said.

“Manufacturers’ business practices may… potentially contribute to a temporary lack of inventory of controlled substances at the point of dispensation. In recent years, this has included labor shortages and a lack of production capacity.”

The DEA’s final order reduces the supply of codeine year-to-year by 8.3 percent, followed by morphine (4.3%), hydromorphone (2.1%), hydrocodone (0.35%) and oxycodone (0.34%). Since 2015, APQs for most opioids have been cut by over two-thirds.

DEA admits that its “reliable data” on drug production may not be all that reliable. The agency said there was a “lack of real-time data and gaps in its understanding of production lead times,” which weaken its ability to respond to drug shortages. As a result, it was seeking more up to date information from manufacturers on their drug sales and inventory.

Late Notice to Drug Makers

The production quotas for 2024 won’t be officially published in the Federal Register until Wednesday, January 3rd – which is about a month overdue and gives little time for drug manufacturers to prepare for the coming year. That appears to be a violation of the Controlled Substances Act (CSA), which stipulates that APQs be established by the U.S. Attorney General – who the DEA reports to -- “on or before December 1 of each year.”  

(Update: In a 1/4/24 email to PNN, the DEA confirmed that drug makers were only now being notified of their quota allotments for 2024. “DEA registrants cannot receive notification of their individual quotas until the final APQ notice is signed and published in the FR (Federal Register) per the CSA,” the email said. There was no explanation for the late publication of the final APQ.)   

Another concern for drug makers besides the late notice is a DEA plan to set production quotas for each company on a quarterly basis, instead of annually. A Pfizer representative expressed strong reservations about that, saying it could hamstring drug production and worsen shortages of injectable drugs used in anesthesia, which have been in short supply for years.  

“DEA’s proposal to allocate quota on a quarterly basis will make manufacturing lead times, planning schedules, and resource allocation extremely difficult if not untenable,” Jennifer Walton, Senior Vice President at Pfizer, wrote in a letter to the agency.

“As an example, from the time API (active pharmaceutical ingredient) is received at a manufacturing plant to the time finished product is ready for shipment, the lead time can be as long as six months, stretching over multiple quarters. Given those time frames, DEA’s proposed quarterly quota grants will likely result in interruptions in supply of sterile injectable products used in the inpatient setting.”  

DEA Cuts in Opioid Supply ‘Completely Irresponsible’

By Pat Anson, PNN Editor

This is the final day for patients, providers and other interested parties to leave a public comment on the DEA’s plan to reduce the supply of opioid medication in 2024.

The DEA wants to cut production quotas for oxycodone, hydrocodone other opioids for the 8th straight year, and invited people to comment on its plan in the Federal Register. Over 3,400 have so far, most of them patients who already have problems getting prescription opioids due to shortages.

“This will do nothing but harm the chronic pain community,” one poster wrote. “The reduction of opioid production will only cause more overdoses, because when people can’t find medication and are suffering, often their only option is to turn to drug dealers.”

“I am a chronic pain patient that would have absolutely no quality of life if it wasn't for opiates. I don't understand why the DEA thinks that pain medication is not a good thing. I would not be able to function without it!” said Joanne Kurtz. “If the government puts more restrictions on the manufacturers, it will be impossible for anyone to get the medicine that is needed. It is nearly impossible now. Please stop decreasing the production!”

“The US population is only getting older, and as more bodies start to fail, the medical need for pain medications will only increase. I’ve noticed a marked decrease in the availability of medications for patients with painful conditions - spine problems, endometriosis, etc,” wrote another poster, who said they worked in the pharmaceutical industry.

“Having the government intervene to limit the supply when legitimate demand is only going to grow is completely irresponsible.”

Also weighing in is the R Street Institute, a non-partisan think tank based in Washington DC that supports free market policies and limited government. The DEA’s proposal, according to R Street, will do more harm than good.

“History teaches us that when the legal supply of prescription medication is reduced too quickly or by too much — whether through problems in the supply chain or restrictions on provider practices — it harms patients by cutting medication access, potentially sending them to the illicit market in an attempt to manage pain, withdrawal, mental health symptoms and more,” wrote Stacey McKenna, PhD, Senior Fellow of Integrated Harm Reduction at R Street. 

McKenna said supplies of opioid medication are “already stretched thin” from previous DEA cuts. And she noted that diversion rates for prescription opioids are quite low.

“The DEA extensively cites the need to minimize diversion as a justification for reducing the 2024 production quotas for opioid painkillers. However, the DEA’s own projected diversion rates are well below 1 percent. Furthermore, the current overdose crisis in the United States is driven not by diverted prescription painkillers, but by illicitly manufactured fentanyl and other synthetic opioids,” McKenna wrote.

“Given the harms associated with restricting medication availability and the extremely low rates of diversion cited by the DEA, we strongly encourage the reconsideration of proposed 2024 reductions on opioid painkiller manufacturing.”

The DEA relies on advice from the FDA on the projected medical need for controlled medications. For 2024, the FDA predicts a decline of 7.9% from 2023 on the medical use of Schedule II opioids.

Since the DEA started slashing opioid production quotas in 2016, the supply of oxycodone has been reduced by over 68% and hydrocodone by nearly 73%. Yet overdose deaths kept rising, fueled primarily by illicit fentanyl and other street drugs.

McKenna told PNN the DEA lacks good evidence to support further cuts in the opioid supply.

“I think the evidence clearly does not support reducing the production quota. I don't see any in the data that I looked at. I see no evidence-based justification to do it,” she said. “I think they're overstepping into decisions that should be between providers and their patients.” 

Patients Urge DEA to Stop Cutting Supply of Opioid Pain Medication

By Pat Anson, PNN Editor

Thousands of people in pain are urging the Drug Enforcement Administration to scrap plans to further reduce the supply of opioid medication in 2024.

The DEA recently announced it would cut production quotas for oxycodone, hydrocodone, codeine and other opioids for the 8th straight year, despite complaints from pain patients and healthcare providers that the medications are already in short supply and difficult to get at pharmacies.

The DEA invited people to comment on its plans in the Federal Register. Over 2,400 have so far – many with heart breaking stories to share about not being able to get the pain medication they need.

“I was finally able to establish a reasonable pain management routine but that was disrupted when my regular pharmacy was no longer able to supply my medication (a moderate dose of Norco) and not a single other pharmacy was willing/able to fill my prescription,” said Jessica Ericksen. “One pharmacy supervisor screamed at my doctor on the phone when he called in to try to get my prescription set up with them. I now have a 1.5 hour round trip drive to get my medication, which is particularly challenging for a disabled person who is unable to drive.”

“I am one of the many that has had my life destroyed by the government regulations on pain meds. I haven't been able to get my medications for the better part of a year,” said Paula Perry. “I'm now basically bedridden and praying for death. Stop doing this to people, we are dying and you guys make it worse every year.”

“Most of us in pain have gone through all of the other drugs to treat our pain and these are the drugs of last resort. The opioids don't totally treat our pain but allow us to function,” said Heather Larson. “The DEA needs to stop playing doctor and let the doctor decide what is right to prescribe. If production is cut anymore, people will commit suicide or go to the street for pain medication.” 

“I have already had to jump through numerous hoops just to be prescribed my meds, but now have to call pharmacy after pharmacy monthly to find my meds, because they are out of stock at every pharmacy around me in a 10-mile radius,” said Jill Bartruff, who suffers from scoliosis. “I also had a surgery in September 2023 and could not find a pharmacy to fill my post op pain meds. I was in immense pain and was unable to advocate for myself to get my meds filled. Imagine being cut open and discharged from the hospital with no pain control.”

“Why do you continue to cut supply when legitimate patients cannot obtain their medications? Many are already out of their meds for weeks on end,” an anonymous poster wrote. “You should be able to see you're making the situation worse.” 

‘More People Will Die’

Why is the DEA planning to reduce the opioid supply for yet another year? The agency wants to reduce the risk of opioid addiction and overdose, and is relying on advice from the Food and Drug Administration, which estimates that medical demand for Schedule II opioids will decline 7.9% from 2023 levels.

But opioid production quotas have been falling for nearly a decade and overdoses have still risen to record levels – fueled primarily by illicit fentanyl, stimulants and other street drugs. 

“The proposed quota will, without any doubt, not only cause harm but actually kill people. Research has shown time and time again that restricting access to safe, regulated supplies of opioids does not result in decreased use, but rather increased reliance on an unstable, unregulated street supply,” Alexandra Bradley wrote in her comment. “The DEA is making a massively dangerous move by even suggesting this quota, and it will result in the deaths of many, many people.” 

“Further reduction of chronic pain relief meds such as oxycodone will literally add to the body count (mostly suicide and withdrawal from abruptly stopping meds) already racked up due to the ongoing shortages,” said Ronald Crook Jr. “What an embarrassment and shame that chronic pain patients such as myself who are just trying to maintain some sense of dignity face being told by our pharmacist that the wealthiest, most powerful nation on earth cannot help us because of quotas.”

“All of us patients, we are the compliant ones with our medications. We go through extensive pill counts and urine drug screens to make sure we are not abusing the substance. The overdoses that are occurring are due to heroin and fentanyl, not prescribed pain medication,” said Candace McFarland. “If you choose to cut people’s medications, more people will turn to the street and more people will overdose accidentally on fentanyl.”

“Individuals that are prescribed pain medication already have a hard enough time getting their medications. I can sympathize. I have ADHD and I've been on Adderall for the better part of a decade. And this year every refill day was anxiety inducing because of the shortage,” said Amber Kunkel. “There needs to be an increase in producing both pain medications and ADHD meds. Without access to safe and predictable drugs, there will be a continued increase in people turning to the streets for medication and dying.” 

The DEA and FDA have responded to complaints of Adderall shortages and other stimulants used to treat attention-deficit/hyperactivity disorder. The DEA plans to modestly raise production quotas for stimulants, after the FDA predicted a 3.1% increase in their medical use in 2024.  

But both federal agencies appear to have turned a blind eye to opioid shortages. The American Society of Health-System Pharmacists (ASHP) has been warning of shortages of oxycodone and hydrocodone for months, but those shortages have not been publicly acknowledged by either the DEA or FDA.

Other factors that could be contributing to opioid shortages are strict limits on the amount that can be supplied to pharmacies – regardless of patient need -- under the national opioid settlement. A suspicious order or “red flag” activity could result in a pharmacy being terminated from receiving anymore controlled substances -- putting added pressure on pharmacists to carefully screen patients and their prescriptions.

Another factor is the low cost of generic opioids. Prices for some generic medicines are so low that some manufacturers can’t make a profit and have stopped making the drugs. Other manufacturers can’t raise production of opioids without permission from the DEA.

DEA Plans Further Cuts in Rx Opioid Supply in 2024

By Pat Anson, PNN Editor

Despite chronic shortages of opioid pain medication around the country, the U.S. Drug Enforcement Administration is planning to further reduce the supply of oxycodone, hydrocodone, morphine and other opioids in 2024.

The DEA sets annual production quotas for opioids and other controlled substances after consulting with the Food and Drug Administration, Centers for Disease Control and Prevention, and individual states about their projected medical and research needs. If the proposed cuts are finalized next month, 2024 will be the 8th consecutive year that DEA reduced production quotas for opioid manufacturers.

“FDA predicts that levels of medical need for schedule II opioids in the United States in calendar year 2024 will decline on average 7.9 percent from calendar year 2023 levels. These declines are expected to occur across a variety of schedule II opioids including fentanyl, hydrocodone, hydromorphone, oxycodone, and oxymorphone,” DEA said in a public notice published in the Federal Register.

There will not be 7.9% cuts across the board for every opioid. The steepest cuts will be in the supply of codeine and prescription fentanyl, while production quotas for oxycodone and hydrocodone will be reduced only marginally.  

Proposed Cuts in 2024 Opioid Supply

- 8.3% Codeine  

- 7.6% Rx Fentanyl  

- 4.3% Morphine

- 2.1% Hydromorphone 

- 0.3% Oxycodone   

- 0.3% Hydrocodone

Since reaching their peak in 2015, DEA production quotas have been reduced by over 68% for oxycodone and nearly 73% for hydrocodone, the two most widely prescribed Schedule II opioids.

The primary goal of the DEA in cutting the supply is to reduce the risk of diversion, abuse and overdose, but there is little evidence the policy is working or even needed. Prescription opioid use has been cut in half in recent years, but overdose deaths have grown to record levels, fueled primarily by illicit fentanyl and other street drugs.

Fears about patients selling or diverting their opioid medication also appear overblown, as the DEA estimates the diversion risk for hydrocodone at only 0.31% and 0.28% for oxycodone. That means for every pill that’s sold or stolen, about 300 pills are used by the patient they were intended for.

Federal health agencies appear to have turned a blind eye to opioid shortages. For several months, the American Society of Health-System Pharmacists (ASHP) has warned of shortages of immediate release oxycodone, oxycodone/acetaminophen tablets, and hydrocodone/acetaminophen tablets. But those shortages have not been publicly acknowledged by the DEA or FDA, and have not been added to the FDA’s drug shortage list.

More ADHD Meds, Cannabis and Psychedelics

The DEA and FDA have been more responsive to complaints of shortages of Adderall and other stimulants used to treat attention-deficit/hyperactivity disorder (ADHD). The DEA is modestly raising its production quotas for stimulants after the FDA predicted a 3.1% increase in their medical use in 2024.

“DEA is committed to ensuring that patients who need stimulant medications have access to them and to ensuring that these drugs are being prescribed thoughtfully and responsibly, and we will continue working with our partners inside and outside of government to do so,” DEA Administrator Ann Milgram wrote in a letter released this week. She said 17 out of 18 drug makers had agreed to increase their production of stimulants under existing 2023 quotas.

In addition to stimulants, the DEA is also raising 2024 production quotas for cannabis, psychedelics and hallucinogens in response to an “increased level of research and clinical trials” involving the Schedule I substances.

The DEA’s quota process may undergo significant changes in the years ahead. The agency wants to be “more nimble” in responding to shortages and increases in demand. To do that, it is seeking access to sales and inventory reports from drug makers to better assess the supply that is available.

“DEA believes that changes to reporting requirements are necessary to improve both the type of data collected and the timeliness of that data, allowing DEA to be more nimble in its administration of the quota program. Future regulatory changes may seek to address the lack of real-time inventory and sales data accessible to DEA, the lack of information on production lead times, and issues of timeliness,” the agency said.

“DEA also is considering methods by which it might increase transparency in its quota setting process. Future regulatory proposals may define additional steps, including such concepts as public notification and an opportunity for public input when prescribing rates for controlled substances deviate substantially from FDA's estimate of future use. Furthermore, DEA is considering regulatory changes which will authorize it to reduce a manufacturer's individual manufacturing or procurement quota in order to apportion it to another manufacturer.”

To leave a comment on the DEA’s 2024 production quotas, click here. Public comments must be submitted online or in writing on or before December 4, 2023.

DEA Finalizes Cuts in 2023 Opioid Supply

By Pat Anson, PNN Editor

The U.S. Drug Enforcement Administration has finalized plans to further reduce the supply of oxycodone, hydrocodone and other commonly prescribed opioids by about 5 percent in 2023, ignoring complaints from patients and healthcare providers that a seventh consecutive year of cuts in opioid production would cause shortages and interfere with the treatment of pain patients.

In a notice published in the Federal Register, DEA said the reduced supply of opioids in 2023 would be “sufficient to meet all legitimate needs.”  The agency has broad legal authority under the Controlled Substances Act (CSA) to establish annual production quotas for drug manufacturers, based on estimated medical, scientific and research needs.  

The 5% production cut in 2023 for Schedule II opioids is not as steep as in prior years, but continues a trend that began a decade ago. Since their peak in 2013, DEA production quotas have fallen by 65% for oxycodone and 73% for hydrocodone.

It’s hard to find any evidence that reducing the opioid supply prevents overdoses. Prescription opioid use has fallen by nearly 50 percent in recent years, but drug deaths have climbed to record levels, fueled primarily by street drugs made with illicit fentanyl.

‘You’re Just Going to Kill People’

Over 350 people and organizations commented on the DEA’s new quotas during a 30-day public comment period that ended in mid-November. Many fear that further cuts in the opioid supply will lead to more suffering and suicides due to untreated pain.

“The DEA should not impose further reduction in the supply of Rx opioids for 2023. There is no correlation between prescriptions and diversion. All the street drugs out there come from Mexico by way of China, NOT a pharmacy,” wrote Anne Hoch. “The DEA are acting as doctors and determining how a doctor does his or her job. The government has to get out of healthcare and respect patient privacy again.”

“Stop reducing production of opioids. There already is a large shortage of pain meds. Why in the world are you reducing AGAIN??! Stop torturing Americans with your disastrous policies. It's quite clear that access to prescription opioids is a problem, so I'm not at all sure what you think you'll gain from reducing production -- you're just going to kill people,” wrote Amber Bullington.

Several people also pointed out that the CDC recently updated its opioid guideline to emphasize there is no hard limit on doses and to give doctors more flexibility in prescribing opioids.

“I believe that the DEA must take into consideration these revised Guidelines, because physicians will no longer be constrained to any arbitrary, hard and fast limit. More, rather than less, opioid daily dosages could be prescribed to certain individual patients who have high impact, intractable pain,” said an anonymous poster.

But the DEA said it would proceed as planned and take a wait-and-see approach to the revised guideline before making any changes to its aggregate production quotas (APQ).

“DEA will consider the impact of CDC's revised guidelines over time, in determining whether DEA may need to publish a revision to the currently proposed APQ values during the 2023 calendar year, when there is sufficient data to provide an understanding of the impact of the guidelines on the actual prescribing as practitioners seek to implement this guidance,” wrote DEA Administrator Anne Milgram, a former Attorney General of New Jersey who has no experience in medicine.

“In addition, DEA's regulations do not impose a maximum limit on the amount of medication that may be prescribed on a single prescription. DEA has consistently emphasized and supported the authority of individual practitioners under the CSA to administer, dispense, and prescribe controlled substances for the legitimate treatment of pain within acceptable medical standards.” 

That comment about no “maximum limit” on prescriptions and the DEA supporting the “authority of individual practitioners” would come as a surprise to many doctors. For years, DEA task forces have targeted doctors who prescribe high doses of opioids deemed to be “outside the usual course of professional practice.” 

Last month the agency suspended the DEA license of Dr. David Bockoff, a California doctor who was treating 240 pain patients, including some from out-of-state who need high doses but were unable to find a local provider. Although Bockoff has practiced medicine for 53 years and has no record of any disciplinary action or complaints with the state medical board, the DEA alleged that he was “an imminent threat” to public safety. Milgram herself issued the order suspending Bockoff’s license to prescribe opioids and other controlled substances.

Within a week of the suspension, a distraught high-dose patient and his wife died in a double suicide in Georgia because he was unable to find another doctor willing to treat his pain. PNN has learned of a second Bockoff patient who died this past weekend, apparently from complications caused by opioid withdrawal. 

Is DEA Practicing Medicine Without a License?

By Pat Anson, PNN Editor

Tomorrow the U.S. Drug Enforcement Administration holds another Prescription Drug Take Back Day, a campaign that encourages people to help combat drug addiction and overdoses by disposing of their unneeded medication at thousands of drop-off locations nationwide.

It’s also a day the DEA uses to further stigmatize the prescription drugs that millions of Americans rely on to control their pain and have functional lives.

“The majority of opioid addictions in America start with prescription pills found in medicine cabinets at home. What’s worse, criminal drug networks are exploiting the opioid crisis by making and falsely marketing deadly, fake pills as legitimate prescriptions, which are now flooding U.S. communities,” DEA Administrator Anne Milgram said in a statement. “I urge Americans to do their part to prevent prescription pill misuse: simply take your unneeded medications to a local collection site.”

The DEA’s campaign to reduce the supply of opioid medication goes well beyond drug take back days. In 2022, the agency is planning to cut production quotas for oxycodone, hydrocodone and other widely used opioid pain relievers. If the proposed quotas published this week in the Federal Register are adopted – and past history indicates they will be – it’ll be the sixth consecutive year the DEA has reduced the supply of opioid medication. 

During that period, production quotas have fallen by 63% for oxycodone and 69% for hydrocodone. And opioid prescribing has fallen to levels not seen in 20-years.

But with drug overdoses climbing to record highs, critics say there is no evidence the DEA’s strategy is working. And they are alarmed that a law enforcement agency is setting policies that affect the healthcare choices of Americans -- in effect, practicing medicine without a license.

“I think a very strong argument can be made that DEA is inappropriately exercising medical judgment based on their reasoning for supporting another production reduction for opioid analgesics,” says Dr. Chad Kollas, a palliative care specialist in Florida. “Federal policy has encouraged blind reductions in opioid prescribing, so for DEA to cite that trend as evidence for a reduced need for the medical supply of opioid analgesics is a self-fulfilling prophecy.

“Reduced prescribing has not led to a reduction in overdose deaths involving opioids, but rather has been associated with an increase in overdose deaths and suicides in patients with chronic pain who have been forced off their pain medications. Federal opioid policy calling for non-focused, reduced opioid prescribing has been an abject failure.” 

18.88% Decline in ‘Medical Need’

Under federal law, the DEA is required to annually set production quotas for opioids and other controlled substances. It does so after consulting with the Food and Drug Administration, Centers for Disease Control and Prevention, and other federal agencies to establish the amount of drugs needed for medical, industrial and scientific purposes.  

"The responsibility to provide these estimates of legitimate medical needs resides with FDA. FDA provides DEA with its predicted estimates of medical usage for selected controlled substances based on information available to them at a specific point in time in order to meet statutory requirements,” DEA explained in the Federal Register.

“With regard to medical usage of schedule II opioids, FDA predicts levels of medical need for the United States will decline on average 18.88 percent between calendar years 2021 and 2022. These declines are expected to occur across a variety of schedule II opioids including fentanyl, hydrocodone, hydromorphone, oxycodone, and oxymorphone."

Asked to comment on the DEA’s statement, an FDA spokesperson said the agency sent a letter to the DEA in April 2021 using pharmaceutical sales data from prior years to create “statistical forecasting models to estimate medical need for the next two years.” The FDA letter never actually used the 18.88% estimate, that was a figure apparently calculated by the DEA itself.

“In the letter FDA provided an estimate for need of each individual active ingredient in various opioid medications for 2021 and 2022. It appears the DEA estimated the 18.88% decrease as an average across the list of opioid active ingredients, presumably based on the estimates we provided.  We do not disagree with their forecast for this decreasing trend of opioid need,” the FDA spokesperson wrote in an email to PNN.

Opioid ‘Red Flags’

In its statement in the Federal Register, DEA also said it relies extensively on data from prescription drug monitoring programs (PDMPs) to find “red flags” that may indicate a drug is being abused or diverted. The DEA is particularly concerned about daily opioid doses that exceed 240 morphine milligram equivalents (MME). That’s a very high dose for most people – and well above the CDC opioid guideline’s recommended limit of 90 MME.

“DEA believes that accounting for quantities in excess of 240 MME daily allows for consideration of oncology patients with legitimate medical needs for covered controlled substance prescriptions in excess of 90 MME daily. Higher dosages place individuals at higher risk of overdose and death. Numerous dispensings of prescriptions with dosages exceeding 240 MME daily may indicate diversion such as illegal distribution of controlled substances, or prescribing outside the usual course of professional practice,” the DEA said.

Where does the 240 MME threshold come from? That’s apparently another case of the DEA coming up with its own estimates to determine whether a dose is medical necessary. It certainly doesn’t come from the CDC guideline, which was never meant to include patients suffering from cancer pain or those in palliative care.

“The DEA is misapplying the CDC opioid guidelines, which were explicitly not meant to apply to patients receiving palliative care,” Dr. Kollas told PNN. “Moreover, it’s disingenuous for DEA to infer that patients receiving higher doses of opioid analgesics are diverting them, when the vast majority of opioid overdose deaths arise from illicit fentanyl in counterfeit pills.”

Just how serious is the drug diversion problem? Not so serious at all, according to the DEA’s own National Drug Threat Assessment, an annual report that for years has said that less than 1% of legally prescribed opioids are diverted.  

“The number of opioid dosage units available on the retail market and opioid thefts and losses
reached their lowest levels in nine years,” the DEA’s 2020 report found.

The same report also found that illicit fentanyl, not prescriptions opioids, is “primarily responsible for fueling the ongoing opioid crisis.” That’s a view shared by the American Medical Association, which declared in 2020 that “the nation no longer has a prescription opioid-driven epidemic.”

‘Stop Punishing Pain Patients’

If that makes you wonder why the DEA is so intent on further reducing the supply of opioids, you’re not alone.

“This is pure insanity. The scientific data from the CDC & NIH (National Institutes of Health) show that the overdose crisis is NOT due to prescription opioid analgesics,” wrote Chuck Robertson, one of hundreds who left comments in the Federal Register on the DEA proposal. “We are in the midst of the worst supply chain crisis in modern history, so you want to continue to cut back on production? All this is doing is putting hospitals and pharmacies at risk of being short medications that people need to control pain.”

“Please don’t cut production quotas of the opioids listed. There are hundreds of stories of people who need opioid medication therapy to even live at the most basic of functionality,” said Michelle Stifle, a chronic pain patient for 22 years. “This inhumane treatment is discriminatory. Stop punishing pain patients for the faults of others.” 

“Please do not cut the quotas anymore. My wife has several autoimmune diseases that cause horrible pain. She was completely cut off of her pain meds after almost 20 years of use,” said Jeffrey Smith. “She never took more than prescribed and never abused them. It allowed her to live somewhat normally. Now she suffers every day and has no life. I'm afraid the time is coming she won't be able to take the pain anymore.” 

“I was forced tapered off my pain meds after taking them responsibly for 17 years. I now spend 75 percent of time in bed. I cannot function and am in constant pain,” said Shelly Allen. “I recently tore my rotator cuff and couldn't even get a few days’ worth. Where there may have been overprescribing there is now underprescribing. It's my body, why can't I choose my own pain relief in reasonable doses?”

“We don't need more cuts to the supply of opiates. It doesn't help avoid addiction or address it. All cutting the supply further will do is promote health care rationing,” wrote Amber Smith. “Opiates are necessary for surgery and other medical needs. Would the DEA ever suggest cutting the supply of chemotherapy or insulin? No, yet those are every bit as necessary to patients as opiates are.”

The DEA did not respond to a request for comment on this story. To leave your comment on the DEA’s proposed 2022 production quotas, click here. Public comments must be received by November 17.

DEA Proposes Cuts in Opioid Supply for Sixth Straight Year

By Roger Chriss, PNN Columnist

The U.S. Drug Enforcement Agency is proposing more cuts in the supply of opioids and other controlled substances in 2022. If adopted, it would be the sixth consecutive year the DEA has reduced production quotas for prescription opioids and other Schedule I and II drugs under the Controlled Substances Act.

Specifically, the DEA is proposing a 5.4% reduction in the supply of oxycodone, 3.9% for hydrocodone, 19% for morphine and 5.4% for prescription fentanyl. That’s in addition to the significant cuts already made since 2017. 

The DEA arrived at the quotas after consulting with the FDA, CDC, Centers for Medicare and Medicaid Services (CMS), and individual states to assess the medical, industrial and scientific need for controlled substances. The DEA also relied extensively on data from prescription drug monitoring programs (PDMPs) to identify “red flags” indicating the possible theft, illicit use and diversion of each substance.

Even though opioid prescribing has dropped significantly over the last decade, the DEA believes demand will fall even further in 2022.

“With regard to medical usage of schedule II opioids, FDA predicts levels of medical need for the United States will decline on average 18.88 percent between calendar years 2021 and 2022. These declines are expected to occur across a variety of schedule II opioids including fentanyl, hydrocodone, hydromorphone, oxycodone, and oxymorphone,” the DEA said in a statement published in the Federal Register.

The proposed opioid production quotas are the smallest in nearly two decades. The trend lines for several common Schedule II prescription opioids can be seen in the chart below. Since their peak in 2013, production quotas have fallen by 63% for oxycodone and 69% for hydrocodone.

Although the DEA maintains the “medical need” for opioids has declined, demand for healthcare has risen significantly. The U.S. population was 281 million in 2000 compared to 331 million today, and in the interim Americans have become older and less healthy, and surgical interventions for cancer and other diseases have become more common, as has trauma care.

In addition, the U.S. has been facing a pandemic for the past year and a half that increased the need for ICU with intubation, for which sedation with opioids is necessary. In 2020, the DEA raised its quotas for some substances because of this unanticipated demand.

In other words, the U.S. is trying to do more with less, trying to manage pain in a larger population with a higher disease burden while using fewer opioid analgesics.

The goal of these ongoing reductions is to address the overdose crisis. But as the CDC reported last week, the U.S. has seen over 96,000 drug fatalities in the 12-month period ending in March 2021. Some of this spike in deaths is a result of to the pandemic, but the ongoing saturation of the country with illicit fentanyl is clearly playing a key role. The DEA recently issued a public safety alert warning of a surge in counterfeit medication made with illicit fentanyl.  

How much further the DEA can go with quota reductions remains to be seen. Surgical and cancer care have been greatly impacted, and rapid tapering of people on long-term opioid therapy is causing harm.

The DEA has not been forthcoming about its ultimate goals and the methods used to assess progress, as it continues to shrink the supply of opioids. At this rate, we will likely reach pre-1995 prescribing levels within another year.

To make a comment on the DEA’s proposed 2022 production quotas, click here. Comments must be received by November 17.

Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society. Roger is a technical consultant in Washington state, where he specializes in mathematics and research. 

DEA Proposes Cuts in Opioid Supply for Fifth Consecutive Year

By Pat Anson, PNN Editor

For the fifth year in a row, the U.S. Drug Enforcement Administration is proposing significant cuts in the supply of hydrocodone, oxycodone and several other opioid pain medications classified as Schedule II controlled substances.

The cuts are partly based on a prediction by the Food and Drug Administration that medical need for the drugs will decline by over a third in 2021.

In a notice published Tuesday in the Federal Register, the DEA proposes to reduce production quotas for hydrocodone by 9 percent and oxycodone by 13 percent in 2021. The supply of hydromorphone would be reduced by nearly 20% and fentanyl by 29% next year.  

The DEA first proposed cuts in the supply of opioids during the Obama administration and the trend has accelerated under President Trump. If approved, the 2021 production quotas would amount to a 53% reduction in the supply of both hydrocodone and oxycodone since 2017.

DEA consulted with the FDA, CDC and the Centers for Medicare & Medicaid Services (CMS) before making its recommendations. The key analysis came from the FDA, which provides DEA with annual estimates of medical usage for controlled substances like opioids.

“FDA's predicted levels of medical need for the United States was expected to decline on average 36.52 percent for calendar year 2021. These declines were expected to occur across a variety of schedule II opioids including fentanyl, hydrocodone, hydromorphone, codeine, and morphine,” the DEA said.

The FDA’s analysis, however, came before COVID-19 infections became widespread in the United States. That led to an increase in demand for injectable opioids used to treat seriously ill coronavirus patients on ventilators.

Faced with growing shortages of those drugs, the DEA issued an emergency order in April raising production quotas for injectable pain medications. Many of those drugs, such as injectable fentanyl and hydromorphone, are still listed on an FDA database of drug shortages.     

DEA said its production quotas for 2021 reflect an “anticipated increase in demand for opioids used to treat patients with COVID-19.”

“Despite this public health emergency, DEA remains focused on the challenges presented by opioid addiction and its effect on the health and wellbeing of the millions of Americans and their families who have become dependent upon or addicted to them. The potential for addiction and misuse exists in every community and remains a pressing health issue with significant social and economic implications,” the agency said.

As PNN has reported, prescription opioids play only a small role in the U.S. opioid epidemic. A new CDC report estimates that nearly 85% of drug overdoses in the first six months of 2019 involved illicit fentanyl, heroin and other street drugs. Prescription opioids were linked to about 20% of overdoses.

In addition to reducing the supply of opioids, the DEA is proposing a significant cut in the production quota for marijuana, which is still classified as a Schedule I controlled substance. To accommodate increased demand for marijuana research, the DEA raised the 2020 quota for marijuana to 3,200 kilograms. Those gains would be reversed in 2021, with production quotas for marijuana and marijuana extracts being reduced to 1,700 kilograms.

Public comments will be accepted on the DEA’s proposed production quotas until October 1, 2020. Comments can be made by clicking here.

DEA Allowing More Production of Opioids

By Pat Anson, PNN Editor

Faced with growing concerns about drug shortages, the U.S. Drug Enforcement Administration has increased the production quotas for some opioid pain medications and other controlled substances.

The move is in response to reports that hospitals are experiencing shortages of injectable fentanyl, morphine and hydromorphone, which are used as analgesics to keep COVID-19 patients comfortable while on ventilators.

“DEA is committed to ensuring an adequate and uninterrupted supply of critical medications during this public health emergency,” acting DEA Administrator Uttam Dhillon said in a statement.  “This will ensure that manufacturers can increase production of these important drugs, should the need arise.”

The emergency order signed by Dhillon increases 2020 production quotas by 15 percent for some Schedule II controlled substances, including fentanyl, morphine, hydromorphone, codeine, ephedrine and pseudoephedrine, as well as other drugs used in their manufacture.

Although some of those drugs have been listed for years on an FDA database of drug shortages, the DEA said as recently as three weeks ago that it was “unaware of any shortages of controlled substances at this time.”

In addition to pain medication, Dhillon’s order increases the annual production quota (APQ) for methadone, which is used primarily to treat opioid addiction. The order also raises the amount of Schedule III and IV controlled substances that can be imported into the United States, including ketamine, diazepam, midazolam, lorazepam and phenobarbital, which are also used to treat patients on ventilators.

“These adjustments are necessary to ensure that the United States has an adequate and uninterrupted supply of these substances as the country moves through this public health emergency,” Dhillon said in the order.

“Although the existing 2020 quota level is sufficient to meet current needs, DEA is acting proactively to ensure that — should the public health emergency become more acute — there is sufficient quota for these important drugs.”

Shortages Began Before Coronavirus

The DEA began aggressively cutting the supply of opioids in 2016 during the Obama administration. The trend has accelerated under President Trump, who pledged to reduce the supply of opioids by a third by 2021.

As recently as last December, the agency reduced 2020 production quotas for hydrocodone by 19 percent and oxycodone by 9 percent. The supply of hydromorphone, oxymorphone and fentanyl was also cut.

Some health officials warned months ago – before the coronavirus outbreak -- that the cuts went too far.

“Some of these medicines, injectable fentanyl and hydromorphone specifically, have been subject to recent and frequent shortages, hindering the ability of doctors and hospitals to conduct critical surgeries and essential patient care,” Corey Brown, Executive Director of Government Affairs for Sanford Health, which operates 44 hospitals in the Midwest, warned in an October 14 letter to the DEA.

“There remains a legitimate need to assure that patients needing surgery and those with short-term or chronic pain in hospitals (or hospice) have monitored access to pain management medications. We are concerned that additional reductions in quotas of these vital medicines may further impact the ability of medical professionals across the country to provide needed care and comfort to patients in a hospital or hospice setting.”  

Last week the DEA issued an order allowing drug manufacturers to increase their inventory of Schedule II controlled substances. But no increase in the production quota was made at the time. A senior DEA official told Reuters the quotas were “completely sufficient” to meet high demand.

The agency changed course after receiving a joint letter from the American Medical Association, American Society of Anesthesiologists, Association for Clinical Oncology and the American Society of Health-System Pharmacists warning that injectable drug shortages were affecting the care of coronavirus patients.  

“Injectable opioid medications such as these are vital for sedation, pain management, and interventional procedures. While oral dosage forms may be available, these are not clinically indicated for ventilation,” the letter said. “Without sufficient IV opioid supply, patients will suffer.”

Once the coronavirus emergency ends, DEA said it would “reevaluate demand and adjust APQ levels as needed.”

DEA Proposes More Cuts in Rx Opioids

By Pat Anson, PNN Editor

For the fourth consecutive year, the U.S. Drug Enforcement Administration is proposing steep cuts in the supply of hydrocodone, oxycodone and three other opioid painkillers classified as Schedule II controlled substances.

In a notice published today in the Federal Register, the DEA proposes to reduce production quotas for hydrocodone by 19 percent and oxycodone by 9 percent in 2020. The supply of hydromorphone, oxymorphone, and fentanyl would also be cut.

“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,” acting DEA Administrator Uttam Dhillon said in a statement.

“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.”

In setting annual production quotas for controlled substances, DEA considers various factors such as medical need, estimates of retail consumption based on prescriptions, and forecasts from opioid manufacturers. Added to the mix this year is diversion.

The five opioids being cut are subject to special scrutiny under the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act, known as the SUPPORT Act, which was signed into law by President Trump on October 24, 2018. The law requires DEA to estimate the amount of diversion of the five opioids and “make appropriate quota reductions.”

The agency estimated that 57 kilograms – about 125 pounds – of oxycodone were diverted or stolen in 2018, along with 24 kilograms (53 pounds) of hydrocodone. There was diversion of relatively small amounts of fentanyl, hydromorphone and oxymorphone last year.   

Cuts Began in 2016

The DEA first began cutting the supply of opioids in 2016 during the Obama administration and the trend has accelerated under President Trump, who pledged to reduce the supply of opioids by a third by 2021.

If approved, the 2020 production quotas would amount to a 60 percent decrease in the supply of hydrocodone since 2016 and a 48 percent cut in the supply of oxycodone.

While overdoses involving prescription opioids have been declining, they’ve been offset by a growing number of deaths attributed to illicit fentanyl, heroin and other street drugs. “Mexican Oxy” – counterfeit oxycodone pills laced with fentanyl – are being trafficked throughout the United States and are blamed for overdoses from New York City to San Diego.

In addition to the five opioids, the DEA is setting production quotas on more than 250 Schedule I and II controlled substances. The agency is proposing to increase the amount of marijuana that can be produced for research by almost a third, from 2,450 kilograms in 2019 to 3,200 kilograms -- almost triple what it was in 2018. The increase reflects growing interest in marijuana research.

Public comments on the DEA proposal will be accepted until October 10. To make a comment online, click here. The agency will publish another notice later in the year on its final decision and begin informing drug manufacturers of their quota allotment.

Trump Administration Proposes More Rx Opioid Cuts

By Pat Anson, Editor

For the third year in a row, the U.S. Drug Enforcement Administration is proposing another round of cuts in the supply of opioid pain medication – a 10% reduction in manufacturing quotas in 2019 for several widely used opioids.  The Trump Administration says the pain relievers are “frequently misused” and reducing their supply will help prevent addiction and abuse.

The DEA proposal involves six opioids classified as Schedule II controlled substances:  oxycodone, hydrocodone, oxymorphone, hydromorphone, morphine, and fentanyl. Some of the medications are already in short supply, forcing some hospitals to use other pain relievers to treat surgery and trauma patients.

“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,” Attorney General Jeff Sessions said in a statement. “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 has already made substantial cuts in opioid production quotas, reducing them by 25 percent in 2017, followed by another 20 percent cut in 2018.  

The production cuts have had no effect on reducing the nation’s soaring overdose rate. According to a preliminary report released this week by the CDC, over 72,000 Americans died of drug overdoses last year, a 6 percent increase from 2016. The rising death toll is primarily attributed to illicit fentanyl, heroin and cocaine. Overdoses involving prescription opioids appear to have leveled off.

The DEA’s latest round of production cuts is in line with President Trump’s “Safe Prescribing Plan” which seeks to reduce "the over-prescription of opioids” by cutting nationwide opioid prescription fills by one-third within three years.

“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.”

‘Serious Consequences’ for Patients

But legitimate patients are losing access to opioids.  Many hospitals and hospices now face a chronic shortage of three intravenous or injectable opioids --  morphine, hydromorphone and fentanyl -- which are used to treat patients recovering from surgery or trauma. Shortages of these "parenteral" drugs have been primarily blamed on manufacturing problems, although some critics say it has been worsened by the DEA production cuts.

“The shortage has serious consequences for patients and physicians. Parenteral opioids provide fast and reliable analgesia for patients admitted to the hospital with poorly controlled pain, patients who have undergone painful procedures such as major surgery, and those who were previously on oral opioid regimens but are unable to continue treatment by mouth,” Edward Bruera, MD, an oncologist at The University of Texas MD Anderson Cancer Center, wrote in an op/ed published this week in The New England Journal of Medicine.

“Shortages of the three best-known parenteral opioids may increase the risk for medication errors when it becomes necessary to switch a patient to a less familiar drug or to use opioid-sparing drug combinations. Opioids are already among the drugs most frequently involved in medication errors in hospitals. There are also increased risks of delayed time to analgesia and of side effects resulting in unnecessary patient suffering and delayed hospital discharge.”

Although opioid prescribing guidelines are only intended for physicians treating patients with “chronic non-cancer pain,” Bruera says some cancer patients are being affected by opioid shortages and over-zealous enforcement of prescribing guidelines.

“Most hospitalized patients and almost all patients with cancer need opioids, either on a temporary basis after surgery or painful treatments such as stem-cell transplantation, or longer for cancer-related pain or dyspnea,” he wrote. “It is impossible to appropriately treat such a large number of patients unless most physicians are able and willing to prescribe opioids. There were not enough palliative care and pain specialists to meet patient needs before the shortages began, and universal referral of patients who need parenteral opioids will therefore only result in more undertreated pain.”

The rationale behind the DEA’s production cuts defy some of the agency’s own analysis. Less than one percent of legally prescribed opioids are diverted, according to a 2017 DEA report, which also found that admissions for painkiller abuse to publicly funded addiction treatment facilities have declined significantly since 2011, the same year that opioid prescriptions began dropping.

DEA Adopts Rule to Further Limit Opioid Production

Pat Anson, Editor

The U.S. Justice Department has finalized a new rule that will allow the Drug Enforcement Administration to reduce the amount of opioid pain medication a drug maker can produce if it finds the opioid is being diverted or misused.

The controversial change in the opioid production quota system was adopted despite warnings from patients, doctors and drug makers that it targets the wrong the problem and could worsen shortages of some pain medications.

The DEA maintains the rule change will “encourage vigilance” on the part of opioid manufacturers to prevent their drugs from being abused.

“These common-sense actions directly respond to the national opioid epidemic by allowing DEA to use drug diversion as a basis to evaluate whether a drug’s production should be reduced,” said DEA Acting Administrator Uttam Dhillon in a statement. “This also opens the door for increased communication and better information sharing between DEA and individual states, as we work together to address the opioid problem plaguing our country.”

The final rule greatly enhances the roles played by states and other federal agencies in setting opioid production quotas. It requires DEA to share proposed quotas with state attorneys general, who could object to a quota and demand a hearing.

The rule also allows DEA to consider “relevant information” from all 50 states, the Department of Health and Human Services, Food and Drug Administration, the Centers for Disease Control, and the Centers for Medicare and Medicaid Services, before setting a quota.

"DEA must make sure that we prevent diversion and abuse of prescription opioids. Today's new rule, by taking diversion of these opioids into account, will allow the DEA to be more responsive to the facts on the ground. More importantly, it will help us stop and even prevent diversion from taking place,” said Attorney General Jeff Sessions.

Sessions announced the proposed rule changes in April, and DEA received over 1,500 public comments during an unusually short comment period. A clear majority opposed the new rule.

“This does nothing to stop addiction or overdose deaths. Addicts will find a high anywhere and where they find it now is street drugs! Illicit drugs are what’s killing, not doctor prescribed opioids filled at a pharmacy. The reporting you all are using is inaccurate and false,” wrote Amy Vallejo.

“By creating quotas, and thereby shortages, you are committing torture,” said Kimberley Comfort, who lives with arachnoiditis, a chronic spinal disease. “There is no reason why people having surgeries, people who suffer from incurable diseases, should be left to suffer when we are a nation that has the ability to take care of its citizens. The DEA does not have a clear understanding of the so-called opioid crisis and therefore needs to cease and desist making opiates harder to get.”

“Again, we have the DEA making laws and quotas on something they should not be. Let them worry about the drugs coming in from China, Mexico etc. which are illegal,” said Sarah Yerxa. “By cutting the quotas all they are doing is sending needy pain patients to the streets, which will just raise the addiction... and overdose problem.”

Opioid Shortages

The DEA has already made substantial cuts in opioid production quotas, reducing them by 25 percent in 2017, followed by another 20 percent cut in 2018. This year’s cuts were ordered despite warnings from drug makers that reduced supplies of opioids “were insufficient to provide for the estimated medical, scientific, research and industrial needs of the United States.”

Many hospitals and hospices now face a chronic shortage of intravenous and injectable opioids, which are used to treat patients recovering from surgery or trauma. The shortage has been primarily blamed on manufacturing problems, although some critics say it has been worsened by the DEA production cuts.

“I believe Attorney General Jeff Sessions needs to sit down and talk to some of these physicians who are pain specialists and understand that what he’s doing is going to put the chronic pain patient, the post-operative patient, and the patient that comes to the emergency room in serious jeopardy,” Tony Mack, CEO and chairman of Virpax Pharmaceuticals, told PNN in an earlier interview.

“I think that Jeff Sessions is not educated well. I think he is picking on something that sounds good politically but doesn’t make sense socially. It’s socially irresponsible.”

In a public notice announcing the rule change, the DEA said it was not responsible for “perceived shortages” of injectable drugs and blamed the “manufacturer induced shortages” on “internal business decisions.”

The agency also deflected criticism that it was targeting the wrong problem. Recent studies indicate that overdoses involving illicit fentanyl, heroin and other street drugs now outnumber deaths linked to prescription opioids.   

“The DEA acknowledges that prescriptions for opioid drug products have decreased over the last several years due to the stepped up civil, criminal, and regulatory enforcement efforts of the agency. However, while there is a downward trend in prescribing, these Schedule II prescription opiates continue to have a high potential for abuse and dependence and require the annual assessment of quotas,” the DEA said.

The agency also claimed prescription opioids were “inextricably linked” to overdoses from heroin and illicit fentanyl, because many addicts start by taking pain medication from family medicine cabinets and then move on to street drugs.

The DEA statement defies some of its own analysis. Less than one percent of legally prescribed opioids are diverted, according to a 2017 DEA report, which also found that admissions for painkiller abuse to publicly funded addiction treatment facilities have declined significantly since 2011, the same year that opioid prescriptions began dropping.

FDA Uncovers Errors in Opioid Database

By Pat Anson, Editor

The U.S. Food and Drug Administration has identified potentially serious errors in a database of opioid sales maintained by IQVIA - a private company that provides data to the federal government on the volume of drugs sold by manufacturers and wholesalers to pharmacies and hospitals.

The FDA said the errors “raise serious questions” about the reliability of IQVIA’s database, which is used by the Drug Enforcement Administration to set opioid production quotas for drug makers. In the last two years, the DEA has reduced opioid production quotas by as much as 45 percent, claiming there was less demand for opioids and that the market was oversupplied with them.

“When we discover irregularities or inconsistencies in the data we use, we take such deficiencies very seriously,” the FDA said in a statement. "The FDA uses these data to assist the DEA in determining the medical and research needs for Schedule I and II controlled substances in the U.S. for the upcoming year."

The FDA believes the error was caused when IQVIA incorrectly converted into kilograms the amount of prescription fentanyl contained in transdermal skin patches and other fentanyl products. As a result, FDA researchers believe the company overestimated the amount of fentanyl sold in the U.S. in the last five years by over 20 percent.

“This error caused IQVIA to overestimate the total amount of fentanyl distributed into the marketplace,” the FDA said. “As a result of this work, we identified additional data quality issues related to several other controlled substances with similar weight-based conversion factors, including oxymorphone and hydrocodone. These additional errors raise serious concerns about systemic issues with IQVIA’s data and quality control procedures.”

Fentanyl is a potent synthetic opioid that is used to treat severe chronic pain and acute pain in patients recovering from surgery and trauma. There is currently a nationwide shortage of intravenous fentanyl and other opioids that has forced some hospitals to postpone surgeries or use other pain medications that are less effective.   

FDA Commissioner Scott Gottlieb, MD, called on IQVIA to immediately hire an independent, third party auditor to conduct a review of its database. Gottlieb said he would brief members of Congress about the data issues and their potential impact on public health.

IQVIA was formed in 2016 after the merger of IMS Health and Quintiles, two prominent healthcare research firms. The company released a statement saying it identified the problems in its opioid database last month and notified customers.  

“Recently, we made a correction to a kilogram conversion measurement in the United States IQVIA National Sales Perspective (NSP) market research service affecting reported measurements for transdermal patches in the opioid market,” the company said. “IQVIA’s internal processes had already identified the measurement conversion issue prior to the FDA’s notification. We notified our clients about this measurement conversion issue in April of this year. Ongoing steps have been undertaken to correct this measurement conversion issue.

“We stand behind our data methodologies. We value our long-standing relationship with the FDA. We take the FDA’s concerns seriously and will continue working with the FDA to resolve these concerns to its satisfaction.”

If confirmed, the database errors would be the second admission by federal agencies this year that their analysis of opioid prescriptions relied on faulty data. In March, four researchers in the CDC’s ironically named Division of Unintentional Injury Prevention acknowledged that many overdoses involving illicit fentanyl and other synthetic black market opioids were erroneously counted as prescription drug deaths.