DEA Plans Further Cuts in Oxycodone Supply

By Pat Anson

The Drug Enforcement Administration is planning to cut the supply of oxycodone by over 6% in 2026, along with marginal reductions in the supply of hydrocodone, morphine and other Schedule II opioids. 

If the DEA’s plans are finalized after a short public comment period, it would be the 10th consecutive year the opioid supply has been reduced in the United States.

The DEA announced its plans Friday in the Federal Register. Under the Controlled Substances Act (CSA), the agency has broad legal authority to set annual aggregate production quotas (APQs) for drug makers – in effect telling them the amount of Schedule I and Schedule II chemicals and medications they can produce. 

The DEA is planning another round of cuts in the Schedule II opioid supply because it continues to see declines in the “medical usage” of opioids – an average decrease of 10.5% in 2024 alone. 

It’s important to note that medical usage is different from “medical need.” Doctors simply aren’t prescribing as many opioids as they used to, so while the need for pain relief hasn’t changed and may have even increased due a spike in rates of chronic pain, the number of prescriptions written for opioids has declined. 

DEA expects that trend to continue, based in part on data from IQVIA, a private company that tracks prescription drug use. The agency is also seeing fewer requests from drug manufacturers to make oxycodone.

“DEA projects that the medical usage of these controlled substances will continue to decline in 2026 based on a review of domestic usage data from IQVIA,” DEA said in its Federal Register notice. “Additionally, DEA has observed a significant decline in requests for product development quotas to support manufacturing towards FDA approval of drug products containing oxycodone.” 

DEA Opioid Production Cuts Planned for 2026

• Oxycodone          6.24% decrease

• Morphine             0.559% decrease

• Hydrocodone       0.529% decrease

• Hydromorphone  0.109% decrease

• Fentanyl              0.014% decrease

• Codeine               0.002% decrease

From year-to-year, the cuts may not appear significant. But over the past decade, there has been an historic decline in the nation’s opioid supply. If its current plan is adopted, DEA will have cut the supply of hydrocodone by 72.9% and oxycodone by 70.6% since 2014.

Some of the decline in “medical usage” is driven by scarcity. For example, Endo Pharmaceuticals recently informed the FDA it discontinued production of 2.5, 5, 7.5 and 10 mg Percocet (oxycodone/acetaminophen) tablets. Major Pharmaceuticals stopped making oxycodone/acetaminophen tablets a few months ago. And Teva Pharmaceuticals, a large generic drug maker, stopped making immediate-release oxycodone in 2023.  

The FDA does not currently list oxycodone products on its drug shortage database, but the American Society of Health-System Pharmacists (ASHP) has since 2023. Limited supplies of oxycodone are available from some manufacturers, according to ASHP, while others have the medications on back order.

Hydrocodone/acetaminophen tablets have also been on the ASHP’s shortage list (but not on the FDA’s) since 2023. Major and Camber Pharmaceuticals have both stopped making them.

Health Canada reported a nationwide shortage of oxycodone/acetaminophen combinations over the summer, a shortage that persists today but is expected to resolve soon.

Why would the DEA be reducing production quotas for opioids that are already in short supply?

DEA sets its APQs after consulting with states willing to share their prescription drug data, as well as federal agencies like Health and Human Services and the Food and Drug Administration. 

DEA also asked for input from the Centers for Disease Control and Prevention, an agency in turmoil after several months of layoffs, budget cuts and leadership changes. A response to that request “was inadvertently delayed” at CDC, but DEA says it will take it under consideration when or if it ever arrives. 

“DEA remains committed to monitoring drug shortages, limiting their impact, and resolving them as quickly as possible. DEA continues to seek additional information that will assist in accurately forecasting domestic medical usage and export requirements of schedule I or II substances,” DEA said.

Unlike previous years, when there was a 30-day period for public comments on the DEA’s quota proposal, the agency is only allowing about two weeks. You can leave a comment here, but it must be posted no later than December 15. DEA did not explain why it was reducing the amount of time the public can comment. 

The PAIN GAME: How Pain Medicine Was Criminalized

By Dr. Lynn Webster

“What happened?”

It’s the most basic question you can ask about the opioid crisis. Yet for more than two decades, most of the answers the public has been given have been pre-packaged: Greedy drug companies, corrupt “pill mill” doctors, desperate patients, and a heroic legal system swooping in to clean up the mess.

What almost no one has seen is what was happening inside those prosecutions as they unfolded; in the homes of the accused physicians, in the war rooms of their defense teams, in the quiet panic of the patients who depended on their care.

That’s what makes The PAIN GAME so extraordinary.

More than twenty years ago, filmmaker Erica Modugno Dagher did something journalists almost never do: she embedded herself at the center of an unfolding legal, medical, and political firestorm and started asking, with a genuinely open mind, “What happened?” 

Then she kept the camera rolling for two decades.

Writer and editor Amy Bianco, who now authors The PAIN GAME on Substack, has taken that trove of footage, documents and human stories, and begun unpacking how the legal system — especially the DEA and federal prosecutors — systematically confused pain medicine with crime, and how that confusion still harms patients today.

If you want to understand why doctors are afraid to treat pain, and why patients are still paying the price, I’d urge you to start with Bianco’s first episode. It’s one of the most important stories you’ve never heard.

Targeting Doctors

The origin of The PAIN GAME runs through the work of political scientist Ronald Libby, PhD, whose 2007 book “The Criminalization of Medicine: America’s War on Doctors” documented a wave of prosecutions in which physicians were recast as criminals. 

Instead of tackling the hard work of healthcare reform or rational drug policy, federal and state authorities went after doctors who billed heavily to Medicare and Medicaid, especially those caring for poor and disabled patients with complex pain.

According to Libby, the logic was simple and brutal:

• High billing = “fraud and abuse”

• High opioid prescribing = “drug dealing”

Under that lens, the DEA and U.S. attorneys didn’t need to understand the nuances of chronic pain, palliative care, or Ehlers–Danlos syndrome. They just needed numbers: prescription counts, morphine milligram equivalents, and outlier billing profiles. 

The more a physician’s practice reflected the grim reality of caring for very sick people, the more suspicious they looked on a spreadsheet.

By the early 2000s, news outlets were saturated with stories of “pill mills” flooding communities with OxyContin. Those stories had a ready-made villain and an easy fix: prosecute the doctor, shut down the clinic, and declare victory.

But as The PAIN GAME shows from the inside, it didn’t add up.

A Camera Inside the Crackdown

Because Libby had earned the trust of embattled clinicians, that trust extended to Erica. She was invited into defendants’ homes, their lawyers’ strategy sessions, back-hall conversations at medical and legal conferences, and even the corridors of Congress.

Crucially, she went in without an agenda. There was no narrative she needed to confirm and no “pill mill” caricature she had to deliver. She simply watched and listened as doctors, patients, lawyers, and advocates tried to understand why the government had suddenly turned medicine into a crime scene. That is what makes the series riveting.

Amy’s first episode on Substack tells this origin story from the inside. She weaves in her own path through the pain world, including her friendship with chronic pain advocate Siobhan Reynolds, founder of the Pain Relief Network, and her own diagnosis with Ehlers–Danlos syndrome. She then patiently walks readers through what the footage and documents reveal.

What emerges is not a defense of every prescribing decision ever made. It is something more unsettling: a portrait of a legal system that decided it was easier to dramatize a few high-profile prosecutions than to grapple with the real drivers of overdose and despair.

When the DEA Writes Medical Policy

Once you see these cases from the inside, the larger pattern comes into focus.

Prosecutors leaned on cooperating witnesses, often people who themselves had been charged, to transform complex medical practices into simple crime stories.

DEA agents and auditors treated prescribing volume as guilt, with almost no capacity to distinguish a high-complexity referral practice from a storefront drug operation.

The media, fed a steady diet of press releases and perp walks, amplified the “drug dealers in white coats” narrative until it hardened into common sense.

And while those courtroom dramas played out, something quieter, and more damaging. was happening across the country.

Doctors who were never criminally charged saw colleagues indicted or their offices raided — which led them to decide that continuing to treat high-risk patients simply wasn’t worth taking the chance. 

Pharmacists also grew skittish about filling legitimate prescriptions. Medical boards and hospital systems imposed rigid rules, less in the service of good medicine than to signal compliance and to distance themselves from the crisis that had been miscast in the public eye.  

The overdose crisis surged forward in the meantime, driven increasingly by illicit fentanyl and a volatile street supply that no prosecution could touch. Prescribing plummeted, while overdose deaths soared.

This is the great irony The PAIN GAME helps expose: The very tools we were told would “fix” the crisis — aggressive DEA enforcement against prescribers — did little to curb overdoses. But they have been devastatingly effective at making it harder for people in pain to get care.

Why The Pain Game is Timely Today

You cannot reconstruct this history by looking backward. Many of the key players are gone. The media environment has only grown more hostile toward anyone who challenges the standard narrative about opioids. The raw fear that Libby detected in the early 2000s has turned into a kind of enforced silence.

That’s why Bianco’s work on The PAIN GAME is so valuable. She and Erica were there as it happened. I have learned that they turned over every page in their research: trial transcripts, medical records, internal memos, and obscure legal filings. They followed the story from exam rooms and courtrooms all the way to Capitol Hill, and they never stopped asking, “What actually happened here?”

If you care about pain medicine, civil liberties, or the rule of law, you’ll find The PAIN GAME both captivating and deeply sobering. It shows, in human terms, how we let a criminal justice narrative substitute for real health policy, and how that mistake still shapes the lives of patients and clinicians today.

The first episode is your entry point into that world. Read it. Sit with it. And then, if you find yourself thinking, No one ever told this part of the story, hit the subscribe button on Amy Bianco’s Substack.

We cannot undo the damage that has been done, but we can tell the truth about how it happened. The PAIN GAME is one of the few places where that truth is being documented, carefully and courageously, in real time.

Lynn R. Webster, MD, is a pain and addiction medicine specialist and serves as Executive Vice President of Scientific Affairs at Dr. Vince Clinical Research, where he consults with pharmaceutical companies.

Dr. Webster is the author of the forthcoming book, “Deconstructing Toxic Narratives -- Data, Disparities, and a New Path Forward in the Opioid Crisis,” to be published by Springer Nature.

Chronic Pain Surged in U.S. After Pandemic

By Pat Anson

Rates of chronic pain and disabling pain surged in the United States after the Covid pandemic, reaching the highest levels ever recorded, according to a new study.

In 2019, about 20.5% of Americans (50 million people) had chronic pain and 7.5% had high-impact pain, which is pain strong enough to limit daily life and work activity.

Pain prevalence remained stable during the pandemic, and by some measures even declined, but in 2023 the chronic pain rate surged to 24.3% of Americans, while high-impact pain rose to 8.9% of the population.

That brought the total number of people who have chronic pain to 60 million, with 21 million having high-impact pain.

“We found that chronic pain, already a widespread health problem, reached an all-time high prevalence in the post-pandemic era, necessitating urgent attention and interventions to address and alleviate this growing health crisis,” wrote co-authors Anna Zajacova, PhD, at Western University in Ontario and Hanna Grol-Prokopczyk, PhD, at the University of Buffalo..

The study is based on results from the 2019, 2021 and 2023 National Health Interview Surveys (NHIS), a federal survey conducted every two years. A preprint of the study was released last year and has now been published in the peer-reviewed journal PAIN.

The 2023 surge in pain was observed in all age, gender, racial/ethnic groups, education levels, and in both rural and urban areas.

Pain increased in almost all body areas, including the back and neck; arms, shoulders and hands; hip, knees and feet; headache or migraine; and in the abdominal, pelvic, and genital areas. The lone area where pain declined was in the jaw or teeth.

Why did pain increase after the pandemic, but not during the pandemic — when people saw doctors less often and postponed or cancelled many health procedures?

One possible explanation is that Covid relief payments, expanded unemployment benefits, and eviction moratoriums eased financial stress.

Working from home and commuting less also lessened physical demands, while giving remote workers more opportunities for self-care.

PAIN journal

“The big question is why we saw this substantial increase in pain prevalence after the pandemic. We examined the role of long COVID and found that it explained about 13% of the increase,” said Grol-Prokopczyk. “None of the other measures we examined — including changes in income or physical health conditions — explained the increase.

“We speculate that abrupt termination of pandemic-era policies, such as remote work arrangements and expanded unemployment benefits, may have played a role.”

In addition to long Covid, researchers also noted an uptick in rates of health conditions that can cause pain, such as arthritis, cancer, cardiovascular disease, diabetes, depression, and anxiety.

The finding of an increase in pain rates conflicts with an FDA analysis that predicted the “medical need” for hydrocodone, oxycodone and other pain relieving Schedule II opioids would decline by 5.3% in 2023. The FDA also predicted a 7.4% decline in the medical use of opioids in 2024 and a 6.6% decline in 2025.

Those FDA projections are important because they are used by the DEA to establish annual production quotas for opioids, which have fallen for nine consecutive years. Since 2015, the DEA has reduced the supply of oxycodone by 68% and hydrocodone by 73%.

When short-term, acute pain is poorly treated, it can have long-term consequences for patients who may transition to chronic pain. Healthcare visits for non–Covid health issues declined dramatically in 2020 and 2021, particularly at hospitals and emergency departments, which are often the first site of care for acute pain management.

Researchers say the lack of adequate and timely pain management during the pandemic may have contributed to more people having chronic pain and high-impact pain in 2023.

“These findings highlight the importance of expanded epidemiological and clinical research on chronic pain to better understand population-level drivers of pain, and to improve national pain prevention and treatment efforts for the many Americans at risk of or affected by pain,” said Grol-Prokopczyk.

What Is Legitimate Pain?

By Dr. Forest Tennant

The question posed by the headline of this article may at first seem ridiculous or unneeded. But a definition of “legitimate pain” is really needed.

Federal government regulations require physicians to get a DEA license to prescribe opioids and other controlled substances. The prescribing must be for a “legitimate medical purpose” -- which is obviously intended to mean legitimate pain. 

It may be surprising, but the federal government doesn’t have a definition for legitimate pain.  State medical boards throughout the United States also do not define legitimate pain, although they monitor physicians for the “legitimacy” of their treatments. 

Recent history has shown that many physicians have been investigated and prosecuted for prescribing opioids without a “legitimate medical purpose,” despite the fact that there is no written definition of legitimate pain to be found in medical regulations and guidelines.

The lack of a written definition of legitimate pain has allowed wide discretion and abuse by prosecutors and their hired medical consultants, making it difficult for doctors to defend themselves against a system that is seemingly rigged against them.

Government agencies, medical boards, professional groups, and insurance plans also call pain “illegitimate” if they don’t like the treatment, dosage, brand, doctor, or cost. 

As unbelievable as it may sound, I’ve read and heard some terribly biased and ignorant definitions of what is and isn’t legitimate pain. 

For example, I’ve heard that a simple need for opioids makes pain illegitimate. The new definition of pain, according to some physicians, is really “opioid use disorder,” which requires treatment for addiction. I’ve also read that pain is a character deficiency and a natural part of life that needs no treatment.

There are some well-meaning persons who claim that pain is whatever the patient says it is. Sorry patients, there are simply too many addicts prowling doctor’s offices with detailed, fraudulent claims of pain fabricated to obtain opioids. Common sense and science tell us to “find the cause of pain before you prescribe.”   

It’s hard to believe, but the International Association for the Study of Pain defines pain as “an unpleasant sensory and emotional experience.”  I can’t wait to ask United Healthcare and Medicare to pay for an expensive drug with this definition.

It is important to point out that the term “legitimate pain” is not only lacking in regulatory guidelines, but it is also not found in medical dictionaries.  Pain may be an experience, emotion or sensation, but it has historically been regarded as a symptom of an underlying disease or injury. 

For example, the Dunglison’s Medical Dictionary of 1874 says “pain is generally symptomatic.”  Medical practitioners today, however, need a new definition of pain because the term “legitimate” is now used to justify treatment with opioids and other controlled drugs. 

Here is my definition of pain, which I believe will generally satisfy all parties, including patients, practitioners, governmental bodies, insurance companies, and the media:

“A stressful symptom caused by a disease or injury that can be objectively identified by diagnostic tests or physical examination.”  

In the past, an argument was made that some causes of pain, such as fibromyalgia and headaches, can’t be objectively verified.  This may have been true in the past, but today’s technological advances in medical imaging and laboratory tests, along with a detailed physical examination, can objectively determine the cause of nearly every source of pain. 

An examination of my submitted definition not only implies that a medical practitioner has the right to treat the patient, it also implies that the practitioner has an obligation to treat both the pain and the cause. 

Forest Tennant, MD, DrPH, is retired from clinical practice but continues his research on the treatment of intractable pain and arachnoiditis. Readers interested in learning more about his research should visit the Tennant Foundation’s website, Arachnoiditis Hope. You can subscribe to its research bulletins here.   

The Tennant Foundation gives financial support to Pain News Network and sponsors PNN’s Patient Resources section.

Are ‘Addicts’ to Blame for Prescription Opioid Crackdowns?

By Crystal Lindell

It’s been nearly a decade since the CDC released its infamous 2016 opioid guideline. In the years since, millions of pain patients have endured immense suffering, as doctors significantly reduced the amount of opioid medication they prescribe.

But who is really responsible for all that pain?

It’s tempting to lay the blame for all the crackdowns on “addicts.” After all, if it wasn’t for them, the rest of us could still get opioids for pain relief, right?

Unfortunately, it’s not so simple. 

The real culprits are the DEA, CDC, and the medical community at large, all of which have worked together to criminalize pain and punish patients.

But blaming ‘addicts” for the crackdown on opioids is exactly what the people with real power are hoping you will do. First and foremost, it has the effect of pitting opioid users against each other, when in reality we’re already on the same team. And as the old saying warns: United we stand, divided we fall. 

Many people who use opioids illegally have chronic pain or other health issues that opioids help address. In a country that does not have guaranteed healthcare, much less guaranteed pain treatment, they are left to fend for themselves. So, it’s no wonder that some of them turn to illegal drugs for relief. 

Using opioids illegally will get you labeled as “an addict,” regardless of the circumstances. In fact, that’s a big part of the reason why I no longer use the word “addict” when talking about illegal users. It’s a murky diagnosis that's often given to deprive patients of a controversial but effective treatment. 

Furthermore, blaming people who use illegal opioids for the fact that many pain patients can’t get an opioid prescription only serves to let the true oppressors off the hook for their crimes. 

We have to remember, it’s not “legal users vs. illegal users.” It’s “all users vs. the DEA, CDC and the medical community.”

I understand where the desire to blame “addicts” comes from. After all, illegal users make a very tempting target. It’s much easier to hate them than to admit that maybe your doctor, who has a lot of power over your life, is actually the one causing you harm. 

It’s also human nature to want to identify yourself as “one of the good ones.” As in: Yes, I use opioids. But I’m different and have a legitimate medical need. 

I mean, obviously, it’s not that simple. But I get why pain patients want to tell themselves that it is. 

The thing is, there are real solutions to the lack of access to opioid pain medication. But we won’t achieve them unless we all work together. 

For example, we could advocate for selling hydrocodone the same way we sell nicotine, alcohol and caffeine: over-the-counter and without a prescription. Eliminating doctors from the equation would help countless pain patients finally get relief, whether they used opioids illegally or legally. And it would be a whole lot safer than the Russian Roulette of drugs on the black market. 

That’s the kind of solution that’s only possible if all opioid users unite in the fight against opioid restrictions. But it won’t happen as long as pain patients insist on telling themselves that there are “addicts” out there that aren’t as worthy as they are.

Because that’s the crux of the issue, isn’t it? Deep down, a lot of pain patients think that people using medications illegally are a separate class of people that need to be banned from accessing opioids “for their own good.” 

Here’s the secret that your doctors won’t tell you though: The medical community has already put you into that group as well. They already think you need to be kept away from opioids “for your own good.” 

In their eyes, both legal and illegal users are one group – so we might as well embrace it. After all, we’re all worthy of pain relief. And all of us should have the right and the ability to treat our own pain as we see fit. 

If we all work together, maybe one day we can make the right to pain treatment a reality. 

Experimental Cannabis Extract Has ‘Potential to Replace Opiates’

By Pat Anson

A German biotech company says it is seeking regulatory approval in Europe and the United States for an experimental cannabis extract that could be an alternative to opioid pain medication.

Vertanical recently completed two Phase 3 studies of its new drug – called VER-01 – on over 1,000 patients with chronic low back pain who didn’t get sufficient relief from non-opioid analgesics.

One study compared VER-01 to a placebo, while the second trial compared the drug’s safety and tolerability to patients treated with opioids. The company told The Times it was awaiting publication of the studies’ findings in The Lancet before making them public.

“VER-01 reduces pain without creating dependency or having an abuse potential,” said Clemens Fischer, MD, Vertanical’s CEO. “It has the full potential to replace opiates as it’s more effective. It’s a real alternative for chronic patients — the first one.

“Pain patients around the world are trapped in a vicious cycle of pain, insomnia, limited mobility, and depression. VER-01 has the potential to successfully break this cycle.”

VER-01 is a “full-spectrum” extract derived from cannabis sativa leaves and flowers. Although it contains THC, the main psychoactive substance in cannabis, Fischer says patients enrolled in the studies didn’t become high or intoxicated. About 25 percent did “feel a bit dizzy” for two weeks after they started taking it.

Participants also didn’t get “the munchies” or gain weight, a well-known side effect of cannabis.

“We were looking very carefully, because that’s what we hear from cannabis smokers — that the appetite increases as well their weight. But we haven’t seen any increase in weight,” Fischer told The Times.

Vertanical is seeking regulatory approval of VER-01 in Europe and with the UK’s Medicines and Healthcare Products Regulatory Agency. If granted, VER-01 would be the first cannabis-based medicine approved for chronic pain. It would be sold under the brand name Exilby and be taken orally in drops.

The timeline for approval in Europe may be as soon as this summer, but it’s likely to take longer in the U.S.

“We are seeking regulatory approval in the US and are in talks with the FDA. For approval in the US, a further phase 3 study with US patients in the indication of chronic low back pain will start in Q2 2025,” Merit Renner, Senior Manager of Business Development at Vertanical, told PNN in an email. “This, together with the phase 3 study successfully conducted in Europe, will form the basis for approval in the US.”

Vertanical also plans further studies of VER-01 on patients with osteoarthritis and peripheral neuropathy.

Research into the pain-relieving properties of cannabis has been slow in the U.S., in large part because of marijuana’s status as a Schedule 1 Controlled Substance, the same classification as LSD and heroin. The DEA recently allowed more marijuana to be used for research purposes, but has dragged its feet about reclassifying marijuana as a Schedule 3 substance that could be used for medical purposes. Until marijuana is rescheduled, VER-01 is unlikely to get FDA approval.

Some recent studies have shown that certain cannabinoids found in marijuana -- cannabidiol (CBD), cannabigerol (CBG), and cannabinol (CBN) – block pain signals in the peripheral nervous system, not the brain, and don’t have a psychoactive effect that could lead to abuse.

“These findings open new avenues for the development of cannabinoid-based therapies,” said Mohammad-Reza Ghovanloo, PhD, lead author of a study published in PNAS and a research scientist at Yale School of Medicine. “Our results show that CBG in particular has the strongest potential to provide effective pain relief without the risks associated with traditional treatments.”

The cannabinoids in the Yale study interact with a protein in cell membranes called Nav1.8, which blocks peripheral nerves from transmitting pain signals. Inhibiting Nav1.8 is the same method used by Journavx (suzetrigine), a non-opioid analgesic recently approved by the FDA for relieving moderate to severe acute pain in adults.

States Wrestle with Kratom Regulation

By Mara Silvers, KFF Health News

Montana lawmakers are grappling with how — if at all — the state should rein in kratom, an unregulated plant-derived substance with addictive properties sold mainly as a mood and energy booster at gas stations, vape shops, and elsewhere.

Kratom, which originates from the leaves of a tree native to Southeast Asia, is also touted for helping relieve pain and opioid withdrawal symptoms. But it can have wide-ranging mental and bodily effects, according to the federal Drug Enforcement Administration, addiction medicine experts, and kratom researchers. Reports of deadly kratom overdoses have surfaced in recent years, though often in combination with other substances.

But the drug is in a gray federal regulatory area: It’s designated by the DEA as a “drug and chemical of concern,” but it is not considered a controlled substance. Legislation introduced in Congress in 2023 to study kratom has not advanced.

The lack of federal regulation and congressional action has left it to states to step into the complex debate over how to clean up supply chains and protect users.

The kratom industry itself wants to help address this regulatory void. A bill drafted by the American Kratom Association, a national industry lobbying group, is pending in the Montana Legislature. In its current form, the industry-dubbed “Kratom Consumer Protection Act” would ban sales to people under 18 and restrict which products can be labeled as “kratom” based on the amount and potency of two chemical components, mitragynine, and 7-hydroxymitragynine.

Similar industry-backed bills have passed in 14 states, including Oregon, Texas, Kentucky, and Maryland, according to the American Kratom Association website. Other states, including Wisconsin and Arkansas, have enacted kratom bans by listing it as a Schedule I controlled substance.

Oliver Grundmann, a University of Florida researcher who has studied kratom since 2016, said industry-written bills often hinge on producers accurately representing what’s in their products. Lawmakers and the public in Montana may not be convinced that the proposed legislation will put public health considerations above commercial interests.

“Naturally, a company is driven by profits and making sure that they can retain their profits,” Grundmann said. “I’m skeptical of self-regulation.”

Whether the Montana bill will be effective hinges on the state’s having enough resources to regulate the industry, as well as industry retailers honestly testing and marketing their products, he said.

The bill’s sponsor, Republican Rep. Nelly Nicol, said she’s trying to bring her fellow lawmakers up to speed on a substance that few people understand. Nicol said she delayed House Bill 407’s first committee hearing to give herself more time to speak with legislators and to hear from groups that support and disagree with the industry’s suggested approach. She indicated she’s open to amending the bill, though it has not yet been rescheduled for a committee hearing.

“We’re going to be changing our minds and learning things and molding this as we’re going,” Nicol said in a February interview.

Potentially Addictive

Researchers and addiction medicine experts have struggled in recent years to pin down kratom’s health effects and patterns of use. A federal survey from 2021 estimated that 1.7 million Americans age 12 and older used the substance in some way the year before the study.

Medical providers and addiction researchers in Montana say patients often don’t disclose their kratom use to health care providers. Some consider it an herbal supplement, a perception driven by its accessibility in gas stations and vape shops, rather than a mind-altering and potentially addictive drug.

Megan Zawacki, a physician assistant and addiction medicine specialist in Helena, said many of her patients seek help for misuse of other substances and aren’t easily convinced of kratom’s negative side effects.

“The majority of my patients that are using it can’t even quantify to me how much they’re using,” Zawacki said.

But if their use spirals into addiction, she said, the consequences of the substance become clearer. At her clinic in Helena, Zawacki said, more of her patients are currently being treated for kratom addiction than for opioid use disorder.

“I’ve had two patients specifically in the last calendar year tell me, ‘We need to bring legislation against kratom,’” she said. “Because it is so readily available and so misunderstood that it just is wreaking havoc on their lives.”

Depending on how it’s manufactured and how much users consume, kratom can function as a stimulant or a sedative.

Though not an opioid, its key chemical components can target opioid receptors in the brain, leading some advocates to cite its potential for helping opioid users manage withdrawal.

Zawacki and other Montana providers say they have prescribed buprenorphine to help patients stop using kratom — the same treatment often used to manage opioid addiction.

“What we have seen in recent years is even stronger extracts that focus specifically on mitragynine and 7-hydroxymitragynine. These should not be seen as ‘kratom’ any longer.”

— Dr. Oliver Grundmann, University of Florida

Some Montana advocacy groups that work to prevent substance misuse have also flagged concerns about kratom use among minors. Beth Price Morrison, with the Alliance for Youth in Great Falls, said her organization has pressured gas stations in the area to stop carrying kratom products or at least keep them behind the counter.

“Our youth are really struggling with mental health right now, and they turn to substances to cope. And this stuff is easily accessible,” Price Morrison said.

Price Morrison and Nicol expressed support for raising the age limit on kratom sales to users 21 and older, rather than 18, which is in the current draft of the American Kratom Association bill.

The legislation would allow state regulators to screen kratom products coming on the market in Montana and create a registry of permitted distributors. Vendors would be banned from selling or promoting kratom products whose concentration of 7-hydroxymitragynine exceeds 2% of the total alkaloid content.

The American Kratom Association and other supporters say that such a restriction would help weed out natural forms of kratom from synthetic, higher-potency concoctions. Some kratom researchers have endorsed this type of market regulation, citing the chaotic array of products currently allowed to sport kratom labels.

Grundmann, the University of Florida researcher, said there has been an “evolution” in the United States of products being labeled and sold as kratom.

“The kratom that was on the market then was basically ground-up leaf powder that was not further concentrated,” Grundmann said. “What we have seen in recent years is even stronger extracts that focus specifically on mitragynine and 7-hydroxymitragynine. These should not be seen as ‘kratom’ any longer.”

Grundmann, who supported a similar version of legislation in Arizona in 2019, said Montana’s bill is a starting point for regulation. He said other states, including Colorado, began with a common framework and put more guardrails in place in recent years.

Price Morrison, the youth prevention advocate, said she has broader misgivings about any bill that normalizes the sale of kratom in Montana. In an ideal world, she said, she would like to see the product banned completely.

“We know that availability drives use. And when a product is marketed as regulated, it gains legitimacy,” Price Morrison said. “And more people, including those who are vulnerable, end up using it.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues.

A Pharmacist’s Oath: ‘The Relief of Suffering’

By Carol Levy

The words “First do no harm” are actually not in the Hippocratic Oath, at least not directly:

"I will follow that system of regimen which, according to my ability and judgment, I consider for the benefit of my patients, and abstain from whatever is deleterious and mischievous."

But the meaning is clear: Do no harm to patients.

I expect that from doctors, although many of us have been disappointed by their adherence to the Hippocratic Oath. What never occurred to me was that pharmacists also have an oath, which includes these pledges:

“I promise to devote myself to a lifetime of service to others through the profession of pharmacy. In fulfilling this vow: I will consider the welfare of humanity and relief of suffering my primary concerns.

“I will apply my knowledge, experience, and skills to the best of my ability to assure optimal outcomes for all patients. I will respect and protect all personal and health information entrusted to me.”  

The DEA has given pharmacists the freedom to ignore their oath, and has coerced some pharmacy chains into handing over our personal health information without a warrant.

Every time a pharmacist refuses to fill a prescription, questions why you need a medication, or asks personal questions, they are not using the “Oath of a Pharmacist.” They are instead exercising a “corresponding responsibility” under DEA regulations, which requires them to make sure a prescription for opioids and other controlled substances is valid and needed.

As far as the DEA is concerned, pharmacists have the same legal obligation as a physician to ensure that a medication has a “legitimate medical purpose.”   

The DEA essentially allows pharmacists to substitute their opinion for that of the doctor, even if it runs counter to their pledge about “the relief of suffering.” Refusing to dispense opioid medication to a pain patient who is dependent on them basically ensures suffering.

I can see some pharmacists saying, “Well, I think that opioids are dangerous. Not filling the prescription is absolutely for the welfare of the patient.”

That argument sounds legitimate. But is it?

The pharmacist has not examined the patient. He/she does not know their medical history or the effect on them when their pain goes untreated. They haven't seen the patient’s x-rays, imaging, and other tests that confirm an injury or disorder that’s causing their pain.

Pharmacists may see us as their “patient" but we are really their customers. They have a product that we want. We come to them with the legally required paperwork to make a purchase. If they have the medication, there should be no issue. They should hand it over and we should pay for it.

If you know little or nothing about a customer, where do you get the right to decide what medication they can get? That decision should be left to our doctors, not to pharmacists or the DEA. 

Those of us in chronic pain have a desperate need for doctors we can trust.  The next step is pharmacists we can trust. Pharmacists who honor their oath to relieve suffering. Not pharmacists who are so fearful of the DEA that they think their best option is to ensure our suffering.

Carol Jay Levy has lived with trigeminal neuralgia, a chronic facial pain disorder, for over 30 years. She is the author of “A Pained Life, A Chronic Pain Journey.”  Carol is the moderator of the Facebook support group “Women in Pain Awareness.” Her blog “The Pained Life” can be found here. 

Physicians and Pharmacists Fear the DEA. Should Patients Sympathize?

By Crystal Lindell

Many doctors and pharmacists are scared about giving patients opioid pain medication because they are worried about getting in trouble. 

They worry about facing consequences from the Drug Enforcement Administration or about breaking local laws and in-house policies. That could mean losing their license, going to prison, or being reprimanded.  

The question is, how much sympathy should this elicit from patients? How understanding should we be of their plight?

Because if you ask doctors and pharmacists, they think the potential consequences should elicit mountains of sympathy – to the point that patients should be able to completely ignore their own physical pain.. 

Whenever I interact with healthcare professionals online or in real life, they will often quickly cite these hypothetical consequences as their reason for limiting opioid prescriptions or administering none at all.

And make no mistake, they are definitely limiting opioid prescriptions. As someone who’s helped many family members navigate the healthcare system, I’ve seen first-hand doctors refusing to prescribe opioids for chronic pain, acute pain, post-op pain, cancer pain, and even hospice pain. 

Meanwhile, even if patients get a prescription, pharmacists seem to do everything possible to avoid filling it. They claim your insurance won’t cover it, that they ran out of your medication, or that they can’t find the prescription that your doctor sent over. 

Doctors and pharmacists will justify these excuses with something along the lines of “I could lose my license! I could be arrested! I could face fines!”

It’s not just my anecdotal evidence though. A study looked at how a 2018 West Virginia law limiting initial doses of opioid medication to a 4-day supply impacted physician attitudes toward opioids. 

In a series of interviews with primary care providers, researchers found that the law “exacerbated the pre-existing fear of disciplinary action and led many prescribers to further curtail opioid prescriptions.”

As one participant, a male primary care physician with 14 years of practice, said:

“[It] really started to scare a lot…of providers into feeling that it wasn't worth the risk to continue to prescribe for fear of being labeled as an over-prescriber or being outside of the norm or, you know, the potential liability that goes along with it.“ 

“Liability.” That’s the key word in that quote. They are worried about themselves. 

The researchers said many providers “felt that taking on patients who legitimately required opioids could jeopardize their career.”

“Their career.” Again, it’s about them.

It’s as though doctors and pharmacists are expecting people in pain to nod their heads sympathetically and respond with something along the lines of: “Oh wow! I didn’t realize how difficult this was for you! But now that you’ve explained your hypothetical consequences, I’ll just go ahead and endure my debilitating pain that’s making me suicidal! Sorry I have burdened you! I sincerely apologize!”

It’s also especially interesting to me that the researchers noted that many of the patients they were talking about "legitimately required opioids.” So it’s not like doctors have some delusion that all these patients they are refusing to treat are "illegitimately" looking for pain meds. 

Medical need is apparently irrelevant when a doctor or pharmacist may get in trouble. 

So I have to tell you, as a patient, I feel about as much sympathy for them as they feel for the patients that they are denying care to – which is to say, almost none. 

The most obvious problem with their reasoning is that these doctors and pharmacists are always citing the potential consequences that they could face when it comes to opioids, while ignoring the very real harm they are causing their patients. 

Make no mistake, they are definitely causing very real and immediate harm to patients when they refuse to treat their pain. People with untreated pain actually do lose their careers, because their pain makes it impossible to hold a job. And when pain patients are forced onto the black market to find relief, they risk losing their lives or their freedom if they get arrested. 

Not to mention the fact that prescription opioids do more than just make the patient feel a little better. They can help patients rest when their bodies need that rest to heal. And they can help patients get through needed treatments like physical therapy. 

This isn’t just a problem for pain patients though. The speed at which doctors and pharmacists have made it clear that they will forgo medical reasoning in favor of “just following orders” should concern all of us.

When doctors start to act as police, we are all in trouble.

DEA Keeping Supply of Rx Opioids Unchanged in 2025

By Pat Anson

The Drug Enforcement Administration says it can’t do anything about shortages of opioid pain medication at U.S. pharmacies and will keep the 2025 opioid supply essentially unchanged from this year’s levels.

Under the Controlled Substances Act (CSA), the DEA sets annual aggregate production quotas (APQs) for every drug maker, in effect telling them the amount of opioids and other controlled substances they can make every year.

The APQs for 2025 were recently published in the Federal Register after a public comment period that received nearly 1,900 responses, many from patients and providers worried about further cuts in the opioid supply.  

“DEA received a significant number of comments from pain advocacy groups, hospital associations, health professionals, and others who raised concerns over the proposed APQs for certain opioids in 2025,” DEA said. “After considering all of the relevant factors, DEA has determined… that U.S. manufacturers will need to manufacture approximately the same amount of those opioids in 2025 as in 2024 in order to meet legitimate needs.”

Although the FDA advised the DEA there will be a 6.6% decline in the medical need for opioids in 2025, the DEA adopted only minor reductions for several widely used opioid medications. They are the same amounts proposed by the agency in October.

DEA Opioid Production Quotas for 2025

• Oxycodone:  0.137% decrease

• Hydrocodone: 0.081% decrease

• Morphine: Unchanged

• Codeine: Unchanged

• Hydromorphone: 0.015% decrease

• Fentanyl: 0.0025% decrease

Although the reductions are tiny compared to previous years, 2025 will still be the ninth consecutive year that DEA has cut the supply of opioids. Since 2015, DEA has reduced production quotas for oxycodone by over 68% and hydrocodone by nearly 73%.

DEA acknowledged receiving many comments from pain patients who said their local pharmacies were often out of opioids, forcing them to contact additional pharmacies and travel further to get their prescriptions filled. DEA said those issues were out of its control.

“Drug shortages may occur due to factors outside of DEA's control such as manufacturing and quality problems, processing delays, supply chain disruptions, or discontinuations,” the agency said.  “Currently, FDA has not issued notice of any nationwide shortages of the types of opioid medications mentioned by these commenters.”

The FDA and DEA may not be tracking opioid shortages, but the American Society of Health-System Pharmacists (ASHP) is.

Opioids currently listed in short supply by the ASHP include oxycodone/acetaminophen tablets, oxycodone immediate-release tablets, hydrocodone/acetaminophen tablets, hydromorphone tablets and solution, fentanyl solution, and morphine solution.

Most opioid medications are generic and cheap to make, but they have low profit margins and come with high risks. Teva Pharmaceuticals, a large generic drug maker, recently discontinued production of oxycodone and potent fentanyl lozenges. The medications were entangled in costly litigation that resulted in Teva paying $4.25 billion to settle opioid liability lawsuits.

Opioid shortages at the pharmacy level are also linked to litigation. Under the terms of a 2022 settlement with drug distributors, opioids are tightly rationed at many pharmacies, resulting in patients with opioid prescriptions being unable to get them filled because pharmacies are out of stock.

Here again, the DEA said the shortages are out of its control and claimed its prosecution of doctors for “unlawful” opioid prescribing was a non-issue.

“Patients and medical professionals may notice specific drug products are out of stock in particular areas; however, DEA cannot dictate DEA registrants' distributions of drug products,” the agency said.

“Additionally, DEA's regulations do not impose restrictions on the amount and the type of medication that licensed practitioners can prescribe. 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.”

Quotas Don’t Prevent Overdoses

For patients reliant on opioids, including those with late-stage cancer, being unable to fill a prescription means withdrawal, uncontrolled pain, and little quality of life.

A palliative care physician recently wrote an op/ed in STAT about “Teresa,” a patient in her mid-60’s with advanced cancer that spread to her abdomen.

“Only her prescription morphine gave her the relief she needed to function and enjoy some small pleasures, like walking her dog in the park,” wrote Dr. Rebecca Rodin, an assistant professor at the Icahn School of Medicine at Mount Sinai.

“But one day, her pharmacy didn’t have her morphine in stock, nor did five other neighborhood pharmacies that she went to. I called another three pharmacies before finding one with a two-week supply available — but it was a 40-minute drive from her home.”   

Rodin says the real culprits in the overdose crisis are illicit fentanyl and other street drugs – not prescription opioids. And no amount of buck passing by the DEA will fix that problem.

“Quotas and resulting shortages of prescription pain medicines are not helping to prevent overdose deaths,” said Rodin. “Quotas are simply turning vulnerable patients with serious illness into collateral damage in a misguided effort to address the opioid epidemic.”   

Return to Sender: WIll Anyone Use FDA’s New Opioid Mail-Back Program?

By Crystal Lindell

The DEA has been hosting drug “Take Back Days” for over a decade, collecting over 9,200 tons of unwanted or expired prescriptions and over-the-counter medicines. The take-back program is seen as a key effort to prevent drug diversion and opioid addiction.

Now the Food and Drug Administration is expanding its own drug collection program – essentially making every day an opioid take-back day.  

Starting on March 31, 2025, drug makers participating in the FDA’s Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)  – which means every company that makes and sells opioids – will be required to provide pre-paid, drug mail-back envelopes “upon request” to pharmacies that dispense opioids. The pharmacies then have to give the envelopes to patients and caregivers who ask for them, so they can mail back any unwanted opioids. 

The fact that both pharmacies and patients have to request these envelopes makes me skeptical about how much this program will actually be used.

The press release from the FDA includes a quote that sounds surprisingly pro-patient though. So even if the program doesn’t have a high use-rate, perhaps an extra measure of safety will make it easier for patients to get opioid prescriptions. 

“We want to ensure patients have access to opioid analgesics in their pain management regimens and that they are educated about methods available to safely dispose of any leftover medicines, which could pose a real danger to their loved ones and pets,” said Marta Sokolowska, PhD, deputy center director for Substance Use and Behavioral Health at the FDA Center for Drug Evaluation and Research.  

It’s the part about ensuring that “patients have access to opioid analgesics” that stands out to me. Patients certainly need access to opioid pain meds. And if programs like this help doctors and medical professionals feel more comfortable prescribing opioids, then I fully support them. 

But I’m skeptical about whether that will be the actual outcome. The real question is whether anyone will use the mail-back program. 

The DEA has never released a full breakdown of the medications returned during its drug take-back days. But an analysis of the drugs returned at a take-back day in Lansing, Michigan in 2013 provides some insight. 

Of the nearly 2,500 medication containers that were returned, only 304 were for a controlled substance like opioids – about 12% overall. The most common types of medication returned were for pain/spasm, cardiovascular, and mental health conditions.

While hydrocodone/acetaminophen combinations (Norco) were the most returned medication at that 2013 event, it represented just 4.4% of all returned containers. 

The second most-common drug returned was ibuprofen (Advil) in 2.2% of the containers. Acetaminophen (1.7%) and aspirin (1.3%) also made the top ten list of most-returned medications. 

Something tells me that Advil isn’t what organizers had in mind when they asked people to bring in their unused drugs. 

In the end, the FDA’s new mail-back program will likely have a greater impact as a public relations initiative to make the agency look good, rather than keeping unwanted opioids off the street. 

In a world where doctors are so reluctant to prescribe opioids, I don’t blame people for wanting to hold on to the opioids they’re able to get. In a PNN survey of thousands of pain patients, nearly a third (32%) admitted hoarding their unused opioids because they’re unsure if they’ll be able to get them in the future 

If we’re lucky, the program will accomplish at least one of the goals that the FDA’s Sokolowska laid out: “We want to ensure patients have access to opioid analgesics.”

Given the federal government's abysmal track record with opioids and pain care in general, I’ll believe that when I see it.

Drug Shortages Easing, But Pain Patients Still Have Problems Getting Opioids

By Pat Anson

Shortages of prescription drugs and other medications appear to be easing in the United States, but with tight supplies of oxycodone, hydrocodone and other opioids persisting.

As of September 30, the number of active drug shortages stands at 277, down from a record high of 323 at the end of last year, according to a new report from the American Society of Health-System Pharmacists (ASHP). The report found that shortages of drugs used for pain, anesthesia, chemotherapy and attention-deficit/hyperactivity disorder (ADHD) “continue to be problematic.”

Health systems also face significant shortages of medical grade intravenous (IV) and dialysis fluids, which have gotten worse in recent weeks due to production shortfalls in the southeast caused by Hurricanes Helene and Milton. To conserve supplies, some hospitals are giving patients Gatorade instead of IV electrolytes. The American College of Emergency Physicians also recommends using tap water to clean wounds rather than sterile irrigation fluids.

Over half of the drug manufacturers (60%) contacted by the ASHP did not provide a reason for the shortages, but others cited increased demand for certain drugs (14%), manufacturing problems (12%), business decisions (12%), and raw material shortages (2%).

The ASHP has also cited reduced DEA production quotas and the fallout from opioid litigation settlements, which have significantly reduced the supply of opioid medication and led to rationing at many pharmacies. In a recent PNN survey, 90% of patients with an opioid prescription said they had trouble getting it filled at a pharmacy.

Teva Pharmaceuticals, a large generic drug maker, recently discontinued production of potent fentanyl analgesics known as Transmucosal Immediate-Release Fentanyl Medicines (TIRF). That forced the FDA to end a program that supplied TIRF medication to about 150 patients, many of them suffering severe pain from late-stage cancer.

Teva has not made any public statements about its discontinuation of the TIRF drugs Actiq and Fentora. The most likely explanation for the discontinuation is that Teva’s bottom line was suffering due to the costs of opioid litigation. In 2022, Teva agreed to pay $4.25 billion to settle thousands of opioid liability lawsuits.

Opioids currently listed in short supply by the ASHP include oxycodone/acetaminophen tablets, oxycodone immediate-release tablets, hydrocodone/acetaminophen tablets, hydromorphone tablets and solution, fentanyl patches, fentanyl solution, and morphine solution. Most have been in shortage for over a year.

‘It’s So Hard to Find My Medications’

The Drug Enforcement Administration recently announced plans to further reduce the supply of prescription opioids in 2025, while raising production quotas for amphetamine and other stimulants used to treat ADHD.

Although the FDA advised the DEA that medical need for schedule II opioids will decline 6.6% next year, DEA is proposing only minor reductions in the supply of fentanyl, oxycodone, hydrocodone and hydromorphone, while keeping quotas unchanged for morphine and codeine. If the quotas are implemented, it would be the ninth consecutive year the opioid supply has been reduced.

Over 1,900 people submitted comments to the Federal Register on the DEA’s plans, many expressing frustration with chronic opioid shortages.

“It’s so hard to even find my medication anymore. I have to go from pharmacy to pharmacy and it causes so much anxiety. I feel so insecure and the unknown makes me sick,” wrote Sierra Shareiko. “It’s like kicking us down while we’re already down. We need to start being smart and looking into how much these medications are actually keeping us alive.”

“In the last year I have had to contact multiple pharmacies in order to get my monthly refill of opioid medication I take for a chronic disease I’ve dealt with for 16 years. Either the pharmacies are out of stock, or they will only fill prescriptions for acute pain,” said another patient. “By throttling production, you’re throwing an already precarious situation further into chaos. You’re putting pressure and stress on the entire medical system and it’s not solving any problems.”

One letter, signed by over two dozen geriatric and palliative care physicians in New York City, warned that any further cuts in the opioid supply would “cause significant harm” to patients.

“In my clinical experience, virtually every time we prescribe opioids for severe and disabling pain in the setting of serious illness, we are required to spend hours tracking down a pharmacy that has the medication in stock. Most do not because their suppliers can't get it for them,” wrote Dr. Diana Meier.

“Our inability to care effectively for our patients because of well-intended but harmful constraints on production and distribution of opioid analgesics is a major source of burn out, frustration, and anger among the already inadequate workforce available to care for the mostly older people living with serious and chronic illness.”

“As a recently retired pain doctor, I saw firsthand just how difficult opiate supply cutbacks made life for my patients. Some reported calling 20 or 30 pharmacies, or traveling a hundred miles, to find pharmacies that would fill their prescriptions,” said Dr. William Taylor. “These cutbacks are a backdoor way to deny medication to patients who have a legitimate medical need for opiate analgesics. There is no evidence that these cutbacks benefit patients in any way.”

The public comment period on the DEA’s proposed 2025 production quotas has ended. The agency is expected to release its final decision on drug quotas before the end of the year.

What Rescheduling Will Mean for Marijuana

By Dr. Chris Meyers

The Drug Enforcement Administration announced in early 2024 that it would act on President Joe Biden’s call to reclassify marijuana, moving it from the tightly controlled Schedule I category that it has been in since 1970 to the less restrictive Schedule III status of the Controlled Substances Act. That triggered a long process of hearings and reviews that will not be completed until after the presidential election in November.

The news drew strong reactions from critics: 25 Republican lawmakers sent a letter to Attorney General Merrick Garland protesting any changes to federal marijuana laws. They argued that the decision “was not properly researched … and is merely responding to the popularity of marijuana and not the actual science.”

As a philosopher and drug policy expert, I focus on assessing arguments and evidence rather than politics or rhetoric. So, what are the arguments for and against rescheduling cannabis?

Scheduling Under Controlled Substances Act

The Controlled Substances Act places each prohibited drug into one of five schedules based on known medical use, addictive potential and safety. Schedule I drugs – which, along with marijuana, also includes heroin, LSD, psilocybin, ecstasy (MDMA) and quaaludes – is the most restrictive category.

Schedule I substances cannot be legally used for any purpose, including medical use or research, though an exception for research can be made with special permission from the DEA. The criteria for inclusion in the Schedule I category is that the substance has a high potential for abuse, is extremely addictive and has “no currently accepted medical use.”

Schedule II, which is slightly less restrictive than Schedule I, includes drugs that are addictive and potentially unsafe but also have some accepted medical use. These include strong opioids such as fentanyl, as well as cocaine, PCP and methamphetamine. Though they are still tightly regulated, Schedule II drugs can be used medically with a prescription or administered by a licensed physician.

Schedule III is much less restrictive and is intended for substances with legitimate medical use and only moderate risk of abuse or dependency. This category includes low-dose morphine, anabolic steroids and ketamine.

Schedule IV – which includes the sedative Valium, the weak opioid tramadol and sleep medicines such as Ambien – is even less restrictive.

The least restrictive category is Schedule V, which includes cough syrups with codeine and calcium channel blockers such as gabapentin and pregabalin. All scheduled drugs require a doctor’s prescription and can be distributed only by licensed pharmacies.

Schedule III Would Only Legalize Some Medical Use

The push to reschedule is largely to make federal laws consistent with state medical marijuana programs that – as of October 2024 – are legal in 38 states plus the District of Columbia.

Moving marijuana to Schedule III would not change its legal status in states where it is banned. It would make marijuana legal at the federal level but only for medical use. Recreational use would still be federally prohibited, even though it is currently legal in 24 states plus Washington.

Rescheduling, however, might not make medical marijuana any easier for patients to access and could even make it much harder for some. Currently, getting a medical marijuana card is quite easy in most states. In Washington D.C., where I live, patients can self-certify.

If marijuana is reclassified as Schedule III, medical marijuana programs will have to start requiring a doctor’s prescription, just like with all other scheduled substances. And it could be distributed only by licensed pharmacies, which would put medical dispensaries that are now selling it without a license from the Food and Drug Administration out of business.

Rescheduling, however, would give medical marijuana legitimacy as a bona fide medicine. And the intent of the move is to increase access, even if it is unclear how rescheduling would achieve that.

So, assuming that rescheduling would have the intended effect of expanding access to medical marijuana, should it be rescheduled?

Medical Uses of Marijuana

Though there are three criteria for Schedule I in the Controlled Substances Act, the DEA in fact relies on only the medical use criterion. This was the basis of the DEA’s proposal to reschedule marijuana. The fact that almost 75% of Americans live in a state with a medical marijuana program suggests that marijuana has an accepted medical use.

More importantly, Schedule III of the Controlled Substances Act already includes dronabinol, which is delta-9 THC, the active ingredient in marijuana. Although dronabinol is synthesized in the lab rather than extracted from the cannabis plant, it is the exact same molecule. The FDA approved THC in the form of dronabinol in 1985 for treating anorexia caused by HIV/AIDS as well as nausea and vomiting due to chemotherapy. Placing marijuana in the same schedule as its primary active ingredient makes a lot of sense.

Another argument in favor of rescheduling is that it would open up new opportunities for medical research into marijuana’s effects, research that is currently hampered by its Schedule I status. This work is critical because the system of cannabinoid receptors through which marijuana causes its therapeutic and psychoactive effects is crucial for almost every aspect of human functioning.

Research has shown that cannabis is effective not only in treating nausea and AIDS but also chronic pain and some symptoms of multiple sclerosis.

There is also good evidence that marijuana can help treat other conditions, including Lou Gehrig’s disease (amyotrophic lateral sclerosis, or ALS), glaucoma, irritable bowel syndrome, insomnia, migraine, post-traumatic stress disorder and Tourette syndrome. Keeping marijuana in the Schedule I category severely hampers research that might establish more effective treatments for these conditions.

Balancing Risks and Benefits

Those opposed to rescheduling cite possible health risks associated with marijuana consumption. Heavy use is linked to an increased risk of developing schizophrenia. However, the increased risk of schizophrenia from cannabis use is comparable to that caused by watching excessive television, eating junk food or smoking cigarettes.

Long-term marijuana use can also lead to sleep problems and diminished visuospatial memory. It can also cause gastrointestinal trouble, such as cannabis hyperemesis syndrome, which is characterized by nausea, vomiting and abdominal pain. The symptoms, while extremely unpleasant, are temporary and occur only after consuming marijuana. The condition disappears in people who stop using.

Marijuana use can also be addictive. According to the Centers for Disease Control and Prevention, about three out of every 10 regular marijuana users meet the diagnostic criteria for cannabis use disorder.

All of the concerns above are legitimate, though it is worth noting that virtually no effective medicine is free from undesirable side effects. And although marijuana can be habit-forming, it is not as addictive as alcohol, tobacco, oxycodone, cocaine, methamphetamine or benzodiazepines. None of those other drugs are categorized as Schedule I, and alcohol and tobacco are not scheduled at all.

Unlike most other prescription medications, marijuana use is associated with many benefits. For example, in states where marijuana has been legalized, worker’s compensation payments have fallen by an average of 21% among people over 40. Researchers think that this is because marijuana helps workers better manage chronic pain. The use of marijuana for pain management also helps to reduce dependency on opioids. One study found that U.S. counties with one or two marijuana dispensaries had an average of 17% fewer opioid-related fatalities compared with counties with no dispensaries.

Research also shows that marijuana use can help to prevent Alzheimer’s by blocking the enzymes that produce amyloid plaques. It also shows promise for reducing a person’s risk of developing Type 2 diabetes by helping the body regulate insulin and glucose levels.

All of these benefits add up to marijuana users having an overall lower rate of premature death than nonusers.

Chris Meyers, PhD, is an Adjunct Professor of Philosophy at George Washington University. His main area of research is in moral psychology, moral theory, and applied ethics/public policy. Meyers is the author of “Drug Legalization,” a textbook that looks at the pros and cons of prohibiting recreational drugs.

This article originally appeared in The Conversation and is republished with permission.

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.

DEA Delays Decision on Reclassifying Marijuana Until After the Election

By Crystal Lindell

The Drug Enforcement Administration has likely eliminated any possibility of marijuana being rescheduled until after a new president is sworn into office next year. The agency will hold a public hearing on the matter on December 2nd —  nearly a month after the presidential election —  according to a notice published yesterday in the Federal Register. 

The hearing will help determine if marijuana should be re-classified under Schedule III of the Controlled Substances Act (CSA) from its current status as an illegal Schedule I substance. 

Moving marijuana to schedule III would place it in a category of drugs that are considered to have an accepted medical use. Rescheduling would also indicate that cannabis has less potential for abuse than Schedule I and II substances, with only moderate to low risk of physical or psychological dependence. 

But the DEA has also made it clear that rescheduling does not equal legalization, noting that “the manufacture, distribution, dispensing, and possession of marijuana would remain subject to the applicable criminal prohibitions of the CSA.” 

To make a cannabis-based medicine legal under Schedule III, the Food and Drug Administration would first have to approve it for a specific medical condition, which would likely require a lengthy clinical trial process that could take years to complete.

The National Organization for the Reform of Marijuana Laws (NORML), an advocacy organization that has long fought for cannabis to be legalized, says it’s not surprised that the DEA wants to have public hearings. 

“Hearings are an integral part of the rescheduling process. To think that the DEA, which historically has opposed any changes to cannabis’ prohibitive status, would sign off on the most significant proposed change in federal marijuana policy in over fifty years absent such hearings was always wishful thinking,” said NORML Deputy Director Paul Armentano.

“That said, the scientific evidence in favor of removing cannabis from Schedule I remains overwhelming. Cannabis clearly has legitimate therapeutic value and it possesses a superior safety profile compared to other Schedule I or Schedule II controlled substances.”

The Biden Administration initiated the regulatory process to review the scheduling of cannabis in late 2022, a review that has dragged on for nearly two years. The Department of Health and Human Services (HHS) recommended marijuana be moved to Schedule III in August 2023.

But the Justice Department and DEA Administrator Anne Milgram – who has the final say on rescheduling – have yet to approve the HHS recommendation.  The DEA published the proposed change in cannabis’ classification in May in the Federal Register. That notice drew over 43,000 responses during a 60-day public comment period, with numerous requests for a public hearing.

Seeing the process take so long is frustrating. With 38 states and the District of Columbia allowing medical cannabis, it’s clear that marijuana has a legitimate medical use – a fact confirmed by the HHS recommendation to reschedule. So why are the DOJ and DEA dragging their feet?  

Holding the public hearing after the presidential election also risks that it won’t be done at all, depending on who wins and what their policy preference is on the matter. 

Although Democratic nominee Kamala Harris is likely to continue President Joe Biden’s push to have marijuana reclassified, we can’t be sure what she would do. Republican nominee Donald Trump has also indicated in recent days that he favors “decriminalizing” marijuana, but we also don’t know with certainty what he would do. 

With so many states having already legalized the medical and recreational use of marijuana, it’s become increasingly clear that there are no compelling health-related reasons to continue classifying cannabis as a Schedule I controlled substance. And the longer the DEA delays changing marijuana’s status, the more it should make all of us question how much health concern there really is behind the Controlled Substances Act.